shot information and teaching slide set oct 2014-forpdf (2).ppt

Paula Bolton-MaggsMedical Director

SHOT

Copyright SHOT October 2014

Lancet April 30, 1983

The baby was transfused in March 1981 but there was reluctance by reviewers and publishers to publish rapidly

NEJM: Confirmed link between transfusion and AIDS 28% of 2157 patients with AIDS had previously been transfused


Surveillance procedures from the collection of

blood and its components to the follow up of the

recipients

To collect and assess information on unexpected

and undesirable effects resulting from the

therapeutic use of labile blood components

And to prevent their occurrence or recurrence


Identify trends in adverse reactions and eventsInform policy within transfusion services, DH, EU Target areas for improvement of practice

Aid production of clinical guidelines for use of blood componentsPromote development of suitable education and trainingIdentify and promote standards of practice

Stimulate research and detailed auditRaise awareness of transfusion hazards and their preventionBe an early warning of new complicationsImprove safety of transfusion for patients


In 1990s - growing awareness of safety issues in blood transfusion

especially HIV, HCV, hospital errors (McClelland BMJ 1994;308:1205)Incidence of major complications of blood transfusion was unknown

Working group set up in 1994 to consider haemovigilance SHOT launched 1996SHOT report first published for 1996-1997 data

Increasing number of reports each yearEvolution of new categories reflecting reports

17th report (2013 data) published July 2014


Professionally led scheme providing analysis of anonymised data by experts in each area of reporting

Regular output in annual report, papers, meetingsRecommendations for actions made to CMOs, DH, hospitals, professional bodies and blood services

Measurable impact on patient safetyReduction in transfusion-related acute lung injury (TRALI)Reduction in ABO incompatible transfusionsReduction in bacterial contamination


Hospital transfusion teamsConsultant haematologistLaboratory managerTransfusion practitioner

On-line reporting systemCategoriesFollow up with incident investigationAnnual reports www.shotuk.org


The European Directive2002/98/EC Blood Safety and

Quality Regulations 2005To set high standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components

To reassure the public that human blood and components, which are derived from donations in one member state, meet the same requirements as those in their own country


UK Blood Safety and Quality Regulations (BSQR) 2005 (SI 50)

Became law Nov 2005

MHRA became the competent authority


All serious adverse reactions same as for SHOTAll serious adverse events signalling a process failure in the Quality Management System (QMS) occurring within the responsibility of the Blood Establishment or the Hospital Blood Bank, regardless of whether the component was transfused (SHOT reportable if transfused)Adverse events involving only clinical staff are not reportable to MHRA, but are reportable to SHOT, comprising the largest sub-group of SHOT reports


Competent Authority appointed by DH to implement new legislation and as regulator

product quality and safety compliance with requirements for QMS

Legal requirement to send numbers of SAEsand SARs to EU annually

first year of mandatory reporting 2008 (June)

May impose sanctions and demand corrective actions on individual sites

not analysing trends or making recommendations


MHRAMHRAMedicines and Healthcare Products Regulatory Agency

SHOTSHOTSerious Hazards of Transfusion

Competent Authority for theBSQR 2005

QMS in blood establishments and hospital blood banks

Competent Authority for theMedicines Act 1968

Competent Authority for theMedical Devices Regulations 2008

STATUTORY reporting

Confidential enquiry

Serious adverse reactions/events AND near misses all of which occur in BOTH a laboratory and CLINICAL environment

PROFESSIONALLY MANDATED reporting

Decision to transfuse

Prescription/request

Sampling for pre-transfusion testing

Laboratory testing

Collection of blood from issue fridge

Bedside administration

Monitoring the patient


SHOT since 1996 set standards in EU and beyond

BSQR implemented from November 2005adverse event reporting to EU mandatory

SABRE web based reporting to MHRA 2005Web-based reporting to SHOT 2010

Initial data entered via SABRE to link case numbers


So what is the greatest risk of transfusion


SHOT Cumulative data: 17 years n=13141

Adverse events due to mistakes

Transfusion reactions which may not be preventable

Possibly or probably preventable by improved practice and monitoring


Errors 77.6%

+

Incorrect blood component transfused Where are the mistakes made?

Copyright SHOT 2014

Laboratory errors

Clinical errors

Incorrect blood component transfused

Data from 220 reports547 errors

Copyright SHOT 2014

Incorrect blood component transfused

Data from 220 reports547 errors

The common combinations of three:

78% request, prescription and administration12% collection, prescription and administration

Copyright SHOT 2014

IdentificationDocumentationCommunication

Copyright SHOT October2014

Outcome of ABO incompatible red cell transfusions66% have no adverse effect

15 deaths to 2005

BSQR

Copyright SHOT 2014

4 deaths 2006-2013

NPSA SPN 14Competency assessments

Immediate and life-threatening : ABO incompatibility; anaphylaxisHours: pulmonary complications, bacterial infections, transfusion reactionsDays: Haemolytic reactionsLate (months or years): viral infections; iron overload


Transfusion reactions may have many overlapping symptoms and signs with varying severityFever, chills, rigor, myalgia, nausea, urticaria, itching, swelling, respiratory symptoms......etc.Advise patients to report any adverse events in 24 hrs after transfusion


A 56 year old man with acute myeloid leukaemia is having a platelet transfusion5 minutes into the transfusion he feels unwellHis temperature has increased to 40oCHe is sweating with severe hypotension


(Choose 1)

1. Allergic reaction2. Haemolytic reaction3. Infection in central venous line4. Infection in platelet bag


ABO incompatibilityContact laboratory immediately

Bacterial infectionCentral and peripheral blood culturesStart broad spectrum antibioticsInform laboratory and haematologist to arrange culture of the unitInform the Blood Service


Stop the transfusion, maintain IV access with saline and check the bag and patient IDRapid medical assessmentInform the transfusion laboratoryBlood culture and return blood bag to labRenal function

Monitor fluid balance (input and output)Collect first and subsequent urine samples


Correct patient identification is vital

PatientPatient

Blood Blood ComponentComponent

TestingTesting

SampleSample


Diagnosis and identification of possible need to transfuseDecision to transfusePhlebotomy for group and crossmatchWritten request to lab for bloodWritten prescription/order/authorisation for transfusionLaboratory testing, component selection and issueCollection from issue siteBedside checking of patient, unit ID and administrationMonitoring/observing and noticing adverse event or reactionAppropriate management of adverse event or reaction


Transposed patient ID during phlebotomy leads to ABO incompatible transfusion

Patient A, blood group O RhD negative, was transfused 2 units of A RhD positive blood during cardiac surgeryOn arrival in ICU he received two more group A units without apparent adverse events.Following transfusion, the patient showed evidence of haemolysis, with a fall in Hb requiring further transfusions, and rise in bilirubin to 241mmol/L within 6 daysHe had an extended stay in ITU.


Patient A and patient B were sampled at the same time in a preoperative clinic. The nurse was distracted while bleeding patient A, did not complete the process at the bedside, and so patient details were transposed when labelling the samples. Near Miss: Patient B s mislabelled sample was detected in the laboratory, because a historical group was available. Adverse event: Patient A had no historical group and the error was not detected.


Why did it happen?What can be learned from it?Corrective and preventive actions to reduce likelihood of recurrence


A child with beta thalassaemia major, blood group O, receives 3 mL of an incompatible unit of blood group ARecognised early, stopped, no harm done, but kept in hospital overnight for observationBlame culture dreadful deed, sack the nurseNo-blame culture- understand the circumstances which led to this and take action to prevent recurrence


(James Reason, 2004)


Likelihood multiplied by the consequence gives a RISK SCORE


Likelihood multiplied by the consequence gives a RISK SCORE

She did not intend to make this mistake but it could have resulted in death, and was very likely to happen again, so was treated as a very serious incident with a high risk score


The nurse was working alone in the day unitThree people needed transfusions she collected all three units at the same timeShe borrowed a nurse from the next ward to check all three, putting each down on a table beside the patientShe was using aseptic technique to access the portacath, and the second nurse handed her the wrong unit which was not checked again at the bedsideIncident recognised when next unit put up with bedside check


The nurse was working alone in the day unitThree people needed transfusions she collected all three units at the same timeShe borrowed a nurse from the next ward to check all three, putting each down on a table beside the patientShe was using aseptic technique to access the portacath, and the second nurse handed her the wrong unit which was not checked again at the bedsideIncident recognised when next unit put up with bedside check

The staff were accepting a culture of chronic understaffing audit showed solo working 75% of the time. Lone working was also associated with a poor record (42%) of correct observations during transfusion. As a result of this investigation, an addition member of staff was employed

The transfusion training of both nurses was out of date, and she forgot that collection of more than one unit at a time was against policy but also it was difficult to get away from the ward on three separate occasions while working alone

The layout of the day unit was reviewed and changed

Key Root Cause: Collection of three units at the same time, and later failure to do the final bedside check immediately prior to transfusion

So, the RCA resulted in several SOLUTIONS to improve the system


An elderly male patient received the first unit of FFP to correct a coagulopathy

Half-way through the unit, he developed marked hypotension (from 100/60 to 50/20) and a widespread urticarial rash and shortness of breath with wheeze


(Choose 2)

1. Discontinue the transfusion2. Continue the transfusion more slowly3. Give hydrocortisone and piriton4. Give adrenaline5. Try a different unit


Allergic or anaphylactic reactions are unpredictable and usually occur earlyThis is why all patients having blood products must be monitoredAdrenaline (IM) is the treatment of choice and should be available in all areas where transfusions take place


Minor reactions excluded


Life threateningRequires immediate interventionIntramuscular adrenalineSupport the airway (oxygen)Longer term: discuss with immunologist how to manage future transfusions

See BCSH guidelines on acute transfusion reactionswww.bcshguidelines.com


An elderly woman with cirrhosis, ischaemic heart disease and a coagulopathy had an elective knee replacementShe was transfused with 2 units FFP and 2 doses of platelets to cover removal of lines and epidural30 mins after completing the transfusion she became suddenly breathless and hypoxic with signs of heart failure


The CXR showed bilateral shadowing and she was known to have impaired left ventricular function


(Choose 1)

1. TACO (transfusion-associated circulatory overload)

2. Chest infection3. Acute myocardial infarction4. TRALI (Transfusion-associated acute

lung injury)


Consider TRALI or TACOCheck airway and give oxygenGet expert medical assessmentCXR and oxygen saturation


Acute dyspnoea with hypoxia and bilateral pulmonary infiltrates during or within 6h of transfusion, not due to circulatory overload or any other likely causes.Most suspected cases are complexNeed expert panel assessmentSerology: find anti-leucocyte antibodies in donor which react with recipient neutrophilantigens


Important cause of transfusion-related mortality and major morbidityCaused by HLA/HNA abs main source is donor plasma:

A donor with a history of transfusionA female donor with a history of pregnancy abs in 10-15%


She was ventilated for 5 days and made a full recoveryShe was also treated with diuretics and IV fluidsShe was investigated for TRALI and this was confirmed by serological evidence of concordant HLA antibodies in one female donor of the apheresis platelets


TRALI relative risk from different components 1996-2003

Red cells Cryo FFP Platelets

TRALI cases 33 2 31 27

Components issued 18,370,000 634,000 2,515,000 1,842,000

Risk/component issued

1:556,000 1:317,000 1:81,000 1:68 000

Relative riskcompared to red cells


Decision to use male donors for FFP


TACO is much more common than TRALI and it can be difficult to confirm the cause of acute respiratory symptomsElderly patients are particularly at risk of TACOEven small transfusions may be enoughAll patients need careful monitoring and appropriate investigation


(unsatisfactory definition)

Any 4 of the following occurring within 6h of transfusion

Acute respiratory distressTachycardiaIncreased blood pressureAcute or worsening pulmonary oedemaEvidence of positive fluid balance


TRALI TACO

Type of component

Usually plasma or platelets

Any

BP Often reduced Often raised

Temperature Often raised Normal

Echo Normal Abnormal

Diuretics Worsen Improve

Fluid loading Improves Worsens


An 83-year-old male with refractory anaemia related to CRF received 2 units of RBCs, each over approximately 1.5 2.5 hours.He had continuing bradycardia during the second unit. He remained stable, but the bradycardiapersisted at 40 45 bpm.Within 15 minutes of the start of the 3rd unit of RBC, he became unresponsive with no cardiac output. Resuscitation was ultimately unsuccessful.A post-mortem examination showed acute LVF, hypertensive heart disease with mitral valve prolapseand hypertensive nephropathy. TACO following RBC transfusion to elderly male with renal impairment and cardiac failure


May need investigation in similar waySustained rise in temperature and/or other systemic symptoms (chills, myalgia, nausea) may indicate bacterial infection or haemolysisManagement may include antihistamines, oxygen etc.


A woman with Hb SC was transfused 2 units of red cells after an emergency caesarian section10 days later she presents with Hb 67g/L, fever hypoxia and pain


(choose 1)

1. Sickle cell crisis2. Delayed haemolytic transfusion reaction3. Bacterial infection4. Pulmonary embolism


She underwent exchange transfusion for sickle crisis but still had symptoms The Hb dropped below pre-transfusion levels with evidence of haemolysis noted on the blood film


(choose any that are relevant)

1. None2. Pre and post-transfusion samples for

group and antibody detection3. Direct antiglobulin test4. Recheck cross match5. Eluate of pre and post-exchange

samples


DAT positive with anti-Jka detectable in eluate on pre- and post-exchange samplesFour out of six units for exchange transfusion were Jk(a+)The anti-Jka became detectable in the plasma after a couple of days


Delayed transfusion reactions in sickle patients may be confused with sickle crisesAntibodies may only be detectable by washing them off the red cells (eluate)Sickle cell disease patients are at particular risk of alloimmunisation and missed special requirements because clinicians forget to tell the lab


Young woman with history of multiple transfusions admitted with Hb 78g/LTransfused 7 d earlier; raised bilirubin and creatinine on this admissionAnti Fyb found now in addition to previously known anti sTwo Fy(b-) s- units transfused but during 2nd unit she had rigors and respiratory arrest


ITU admission for a weekInvestigation: new weak anti-Jka by enzyme onlyBoth units were Jk(a+) as were 2 of the 4 transfused 7 d beforeAcute and delayed HTR


Symptoms Investigations

Fever >2oC rise or >39oC

Standard plus repeat compatibility testing, DAT, LDH and haptoglobinBlood cultures from patientCoagulation screenDo not discard unitSustained fever: return unit to lab, repeat antibody screen and DAT

NB. Standard investigations for all transfusion reactionsFBC, renal and liver function, assessment of urine for haemoglobin


Symptoms Investigations

Mucosal swelling Standard, plus IgAIf <0.07g/L and no general hypogammaglobulinaemia confirm and look for IgA antibodies

Dyspnoea, wheeze or features of anaphylaxis

Standard, plus oxygen saturation/blood gases, CXR;

Hypotension (isolated fall systolic of > 30mm resulting in level >80mm

Investigate as for feverIf allergy suspected, IgA


Definition: sudden onset of thrombocytopenia occurring 5-12 d following red cell transfusion associated with antibodies in the patient directed against human platelet antigen systems. Commoner in women, rare (1-2 pa)Management: IVIgWomen are at risk of neonatal alloimmunethrombocytopenia in future pregnancies


Category Risk per components issued

Total risk of death (including probable cases) 1 in 125,000

Total risk of major morbidity 1 in 19,157

Risk of death from error 1 in 454,545

Risk of major morbidity from error 1 in 196,078

Risk of death from TACO 1 in 227,273

Risk of major morbidity from TACO 1 in 81,3000

Risk of major morbidity from ATR 1 in 36,764

Category Risk of infected donation entering blood supply

HBV 1 in 1.3 million

HCV 1 in 28.6 million

HIV 1 in 7.1 million


Viral infectionsIdentify and reportEstablish link with previous transfusionCounselling and management

Iron overloadThink of this in any chronically transfused patient and do regular assessment of iron loadingMay be missed in young patients undergoing cancer chemotherapy?


(n=39)

ADU 1 Inappropriate and 5 delayed transfusions

IBCT 1 ABO incompatible transfusion

PTP 1 Post-transfusion purpura

ATR 2 Acute transfusion reactions

HTR 3 Haemolytic transfusion reactions

TRALI 2Transfusion-related acute lung injury

TACO 20 Transfusion-associated circulatory overload

Unclassifiable 3 - 2 infants with necrotising enterocolitis and 1 adult after IVIg

TA-GvHD 1 transfusion-associated graft versus host disease


Fludarabine introduced for CLL induces profound lymphopeniaTA-GvHD cases reported in 1993, 1994, 1996Guidelines for irradiated blood components 1996 (latest update 2010) B cell diseases are not an indication on their own for irradiated products


Omission of irradiation in 999 patients at risk

Many cases missed in patients who have received fludarabine

Leucodepletion is protective


Patient group NumberTreatment with purine analogues 178

Hodgkin lymphoma 68

Haemopoietic stem cell transplants 44

Others 99


Reasons for failure to provideirradiated components

Haematology clinical staff forget/fail to inform the transfusion laboratoryNeed for irradiation overlooked when patient is admitted to a different specialty or hospitalNeed for irradiation is forgotten when historical (e.g. HD, fludarabine many years before)Immune deficiency not recognised (CVID, Di George syndrome)Overlooked in infants needing later top-up transfusion after intrauterine or exchange transfusion


UK Transfusion Laboratory

Collaborative2009

BCSH Guidelines


1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Better blood transfusion initiativesDH circulars

Working group set up to discuss national strategy for

haemovigilance

SHOT launchedStart ofNPSA

NBTC

Nationalcomparative audit

programme UKTLC

NPSA SPN14 Right patient, right blood

competency assessment

NPSA SPN11 Patient identificationWristbands

NPSA RRR 17Transfusion in an

emergency

Figure 1

SPN 24


A programme of clinical audits looking at use and administration of blood and blood components in England and N WalesFunded by the NHSBTStarted 2003, in collaboration with the clinical standards unit of the RCP

http://hospital.blood.co.uk/safe_use/clinical_audit/national_comparative/index.asp


http://hospital.blood.co.uk/safe_use/clinical_audit/national_comparative/index.asp

IdentificationDocumentationCommunication


Further information available:

http://www.shotuk.org/Educational resourcesCategory definitionsAnnual Reports (including key to abbreviations)

http://www.mhra.gov.uk/


Hazel Tinegate and the transfusion task force of the BCSH for ATR guidelinesHospitals for reporting cases to SHOTSHOT experts and incident specialists


shot information and teaching slide set oct 2014-forpdf (2).ppt

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