National Haemovigilance Office Report 2006

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National Haemovigilance Office Report 2006

• Marina Cronin
• On behalf of National Haemovigilance Office
• 07/11/2007

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Breakdown of SAR SAE/IBCT Reports 2000-2006
(N1349)
SAE/IBCT- Incorrect Blood Component Transfused
STTI- Transfusion Transmitted Infection AA-
Severe Acute Allergic/ Anaphylactic
Reaction TRALI- Transfusion Related Acute Lung
Injury TACO- transfusion Associated Circulatory
Overload PAD- Pre- Deposit Autologous
Donation DHTR- Delayed Haemolytic Transfusion
Reaction AHOSTR- Acute Haemolyic or Other Severe
Acute Transfusion Reaction
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Reports received to National Haemovigilance
Office 2006, N 344
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REPORTS OF SERIOUS ADVERSE REACTIONS
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SAR 2006,N117
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Acute haemolytic and other severe transfusion
reaction, n 40
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FNHTR N38

• Age categoriesAdult 31-69-39, Elderly gt70- 42
• Most common symptoms- rise in temperature (0.5-
  3.5 degrees), chills and rigors, tachycardia
• Recovery
• Without ill effects 36
• Unspecified- 1
• Died unrelated to transfusion -1

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Components implicated in FNHTR, N 38
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Imputability of FNHTR, N38
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Investigations conducted in FNHTR N38
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Acute immunological haemolysis due to other
alloantibody N2

• Red cells implicated in both
• Both cases involved limitations in laboratory
  systems
• Case 1-Patient developed increased temp, rigors
  and vomiting. Reaction associated with weak
  anti-E not detected at crossmatch due to the use
  of an insufficently sensitive technique.

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Acute immunological haemolysis due to other
alloantibody N2

• This elderly man received 6 RCC for
  gastrointestinal haemorrhage. At that time he
  had anti-E and anti-Cw antibodies and was given
  E/Cw negative red cells.
• Ten days later he was transfused a further RCC
  for low Hb
• Approx 150mls had been transfused, he developed
  hypertension, tachycardia and a temperature rise
  of 1.7oC and rigors. Bilirubin LDH were
  raised.
• Serological investigations on the post
  transfusion sample showed that the DAT was
  positive. Additionally he had developed anti-
  Fya, anti-K, anti-Jkb and anti-S. The phenotype
  of the transfused unit was Fya, Jkb positive.
• Further investigations found that the patient had
  been crossmatched through human error on a sample
  which was eight days old instead of a fresh
  sample and the patient had developed multiple red
  cell antibodies since his initial transfusion
  leading to acute haemolysis

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Anaphylaxis /Hypersensitivity N29

• Formely known as AA
• Age range neonate (1) to elderly (gt70 yrs)-4
• Time range of onset of symptoms immediate to
  6.25 hours
• Most common symptoms- urticaria, tachycardia,
  dysponea, chills/rigors, restlessness/anxiety

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Components implicated in Anaphylaxis/Hypersensitiv
ity N 29
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Imputability of Anaphylaxis/Hypersensitivity N 29
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Anaphylaxis /Hypersensitivity N29
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Delayed Immunological Haemolysis due to other
Allo Antibody N 4
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TRALI N2

• Reports of suspecd TRALI 8
• DNP- 2
• TRALI investigations conducted -4
• Reclassified as TACO- 4
• Confirmed TRALI- 1
• Possible TRALI -1

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Case history -TRALI

• Six days after surgery an elderly female patient
  had a transfusion of a unit of red cells.
• One hour into the transfusion she developed
  hypotension, tachycardia, falling O2 saturations
  and chest x-ray changes compatible with Acute
  Lung Injury, requiring ventilation.
• Class I HLA antibodies were detected in the
  patient.
• Investigation of the female donor showed the
  presence of anti HLA class I antibodies with
  multiple specificities including anti A1, as well
  as class II antibodies.
• Granulocyte antibodies were not detected in
  either the donor or patient at the Platelet and
  Granulocyte Immunology Laboratory, NBS, Bristol.
  
• The donor has been permanently deferred. The
  patient remained ventilated and recovered, but
  remained ill from underlying disease

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TRALI

• Definition of TRALI is a clinical one acute
  onset, hypoxemia with bilateral infiltrates on
  chest x-ray and absence of circulatory overload
  occurring within six hours of transfusion
• Confirmation of TRALI is based based on
  laboratory investigations
• Laboratory investigations ensure safe blood
  supply.

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TACO N34

• Age Adult (31-69) -13, Elderly (70yrs) -19
• Time to onset of symptoms 20 mins 12 hours (7
  cases outside 6 hours)
• Most frequently reported symptoms dyspnoea,
  hypertension, falling O2 sats.
• Components implicated RCC- 32, multiple
  components 2
• 44 were single unit transfusion events

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Imputability of TACO N 34
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TACO case history

• This case clearly illustrates the potential for
  TACO associated with replacement therapy for
  severe bleeding.
• A previously healthy young female patient with
  severe anaemia and intra abdominal bleeding
  received 2 units of red cells in 1 hour followed
  by 2.5 L fluids over a short time and developed
  respiratory symptoms. While pulmonary oedema
  was initially deemed unlikely, it was later
  confirmed on x-ray, and the patient recovered
  following Frusemide and Continous Positive
  Pressure Ventilation (CPAP).
• Report initially submitted as TRALI-donor
  investigations were negative.

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Outcome of TACO N34
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Role of BNP

• It can often be difficult to differentiate
  between TRALI and TACO.
• Pre and post transfusion B-natriuretic peptide
  (BNP) levels may be helpful in differentiating
  TACO from TRALI (Zhou et al 2005).

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Viral STTI N5
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Bacterial STTI, N3
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Reports of SAE /IBCT
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Definition - IBCT

• IBCT ( non-mandatory SAE) the transfusion of a
  blood component / product which did not meet
  appropriate requirements and / or was intended
  for another patient

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Definition-SAE

• Serious Adverse Event (SAE) ..any untoward
  occurance associated with the collection,
  testing, processing, storage and distribution of
  blood and blood components that might lead to
  death or life threatening, disabling or
  incapacitating conditions for patients or which
  results in , or prolongs hospitalisation or
  morbidity.

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Breakdown of IBCT / SAEs Involving Components by
Nature of Event (n155)
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Findings N155
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What is other (N61)?

• Transposition of labels in cross match 5
• Units unlabelled for transfusion -3
• Otherwise low risk (level 3) events
• Transfusion time exceeded-16
• Failure to prescribe, document or correctly
  identify patients- 10

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Unnessary transfusion- N51
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Unnessary transfusion- N51

• Clinical errors -49
• Errors in sampling -7
• Verification errors -9
• Inappropriate use of SD plasma- 11
• Errors in clinical judgement RCC-11
• Errors in clinical judgement Platelets- 5
• Administration errors_at_ bedside -5
• Failure to check patients blood count - 1
• Laboratory processing errors- 2

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Incorrectly stored units transfusedN12

• All events involved RCC
• 4 events- units returned after 30 minutes and
  subsequently transfused after recommended 4 hours
• 4 units returned to BT lab for disposal, not
  placed in a quarantined area, and were
  subsequently collected for transfusion
• 2 units stored in a unmonitored ward fridge
• 2 units returned, but not logged in and were
  re-issued for transfusion without confirmation of
  how long out of fridge

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Who discovered the error?N155
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High Risk Steps in the Work Process/Site of first
error N155
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Root cause of errors at prescription /request,
N64
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EU Haemovigilance-Reporting of SAR/SAE/IBCT 2006
IBCT 123
SAE-EU 32
SAR-4 SD plasma, 1 serological reaction
SAR-EU 112
EU SAR
SAR 5
EU SAE
IBCT (non mandatory reports -components)
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Breakdown of SAEs N32
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Key take home messages

• Importance of investigation of SAR at hospital
  level
• Investigation of SAE/IBCT
• involves risk assessment,
• looking at how and why,
• action to be taken to correct and minimise risk
  of recoccurance.
• Importance of HVO audit clearly identified.
• Inappropriate /unnessary transfusion

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Changing Profile of IBCT/SAE Reports 2000 -2006