VIEWS: 24 PAGES: 27 POSTED ON: 1/29/2011
Christine McQuillian (Transfusion Laboratory Manager-TLM) and Jan Gorry (Transfusion Practitioner-TP) To share and discuss our Incident reporting policy cited as best practice at MHRA and CPA inspections To explain how we investigate incidents To demonstrate our tracking and trending process Aintree is a 1000 bedded acute Foundation Hospital which also provides transfusion services to The Walton Centre, and The Women s Aintree site, plus a private hospital and dialysis unit. In total we transfuse 10-11,000 red cells per year, and around 1,800-1,900 platelets and FFP. We process 23,000 group and screens. All staff have a duty to report transfusion incidents and near misses regardless of the impact on the person involved. The member of staff who connects the pack is responsible for reviewing the observations to detect a possible transfusion reaction. The clinician who is asked to manage a suspected reaction is responsible for reporting the reaction to the Transfusion Department Any person who discovers a transfusion near- miss or adverse event is responsible for reporting it to the transfusion department. The TP or TLM is responsible for logging the incident on the incident record sheet. The TP is responsible for investigation of clinical reports / logging in Q-Pulse/ external reporting The TLM is responsible for investigation of laboratory reports / logging in Q-Pulse/ external reporting The Transfusion Team are responsible for reviewing and categorising serious reports The TP is responsible for correlating all reports into a risk report on a quarterly basis-reviewed at HTC and by the Trust Risk Group. Trust clinical incident (DATIX) reports are also completed for serious reports (SAR/SAE and SHOT incidents/NM). Serious adverse reaction (SAR) Serious adverse event (SAE) SHOT near miss Minor non compliance (MNC)- For example on wards this would be a missing traceability record or failure to follow procedure. For the laboratory this would for example be a minor data entry error, or failure to spot a sample labelling error at first check. Quality Incident (QI) examples: communication problems, QC problems, equipment problems, failure to follow procedure etc Blood storage Wrong blood in tube Erroneous sample Erroneous request Labelling error Requirement Data entry Laboratory process Collection/ administration Traceability QI, MNC, SHOT NM, SAR, SAE reported to Transfusion Department Incident is logged via Transfusion Department Incident Record Sheet and also the QPulse Compliance and Improvement Management System. Incident categorised and discussed by HTT. SHOT NM SAE SAR MNC or QI Report to SHOT /SABRE via SABRE Report to Clinical Website Governance / Clinical Risk dept via Risk complaints and Quarterly Report, Standards for Better Health Report, and Clinical Risk Working Group Corrective procedures actioned via HTT liaising with HTC/ Clinical Risk/ Clinical Governance Groups Corrective actions logged via QPulse Management System. 2 no-harm events where blood was issued after the sample had passed 72 hours valid time. One no harm event when blood was issued and transfused to a patient which should have been E negative (the patient did not have Anti-E) An antibody identification panel was used for testing after the expiry date. Summary of Transfusion Errors Between 01/01/08 and 31/03/08 Lab Testing 100% Traceability 90% 3 % of Error Category Collection / Administration 80% 11 4 1 Blood Storage 70% Wrong Blood in Tube 60% 4 Erroneous Sample 50% 10 Erroneous Request 40% 2 Labelling 30% 1 4 1 Requirement 20% 2 Data Entry 10% 6 1 0% Lab Minor Non- Ward Minor Non- Lab SHOT Near Ward SHOT Lab SHOT Ward SHOT compliance compliance Miss Near Miss Incident Incident Error Category Laboratory Incidents Jan 09 - Mar 09 Supplier Error, 1 Haem Cover Communication, 3 Haem Cover Communication Chart Error, 5 Compliment, 1 Compliment Batch Product Transfer Problem Batch Product, 2 Process Error Data Entry Chart Error Transfer Problem, 1 Supplier Error Data Entry, 5 Process Error, 6 SHOT near miss: 38% Laboratory / 62% Clinical areas MNC : 36% Laboratory / 64% Clinical areas Comprehensive policy and process Local investigation and review Trending Means that hopefully we have a good idea where our risks/problems are and where we need to concentrate scarce resources. Inspectors saw evidence that the Trust responds to risks which HTT escalated. MHRA Inspector commented that the incident sheet sometimes lacked sufficient detail. As a learning point we now copy and keep all associated documents with incident sheet. 180 180 160 140 126 transfusion 'SHOT incident' (or SAE from 120 2006) 100 near-miss 80 75 72 60 39 48 minor non-compliance 40 26 or quality issue 17 20 7 7 8 1 3 4 0 2003 2004 2005 2006 2007 2008 Sample received details on request form (addressograph) and sample bottle (handwritten) match Sample processed grouped A RhD Pos Historical record 0 RhD Pos Second sample requested 0 RhD Pos Wrong Blood in Tube (WBIT) Establish who took sample Visit staff/area involved Discuss events which led to mistake Sample taken the labelled remotely from patient using incorrect details on request form Breach of TRUST POLICY identified Incident Form Completed SHOT NEAR MISS (category) Recommend attend venepuncture update NPSA Competency assessment Importance of correct procedure as per Trust Policy Incident highlighted to Line Manager and Clinical Risk Lead Q Pulse Completed Datix Completed Unique Ref Number Generated Copy sent to Clinical Risk Lead Discussed at HTT & HTC Actions formulated Highlighted at Clinical Risk Group Meetings Copy sent to Clinical Risk & Clinical Governance Devised Safety Posters for Trust wide distribution Added to Induction & Mandatory training Sessions Lesson of the Month July 2008 On going education/awareness NPSA Competency assessments ongoing Suspected TRALI - this involved a patient transferred from affiliated Trust to ITU at UHA with ARDS within 24hours of having a transfusion (6units RBC). Confirmed platelet reaction involving a patient who displayed signs of a reaction after approximately 50mls were transfused Delayed Transfusion Reaction patient was admitted one week post transfusion of 4 units RBC with sudden onset jaundice and haematuria. Symptoms were consistent with a (DTR). This type of reaction is recognised as an unavoidable risk of transfusion, where an antibody developed in the past drops to levels undetectable in laboratory tests. Quarter on quarter, year on year trending would be useful. Plan to amend incident form to match Q-Pulse data entry.
Pages to are hidden for
"The Aintree Approach to Transfusion Incident Management _CMc JG_"Please download to view full document