Annual Notification Form of EU Directive Findings 2006

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Annual Notification Form of EU Directive
Findings 2006

• Jacqueline Sweeney
• National Haemovigilance Office

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EU Directive 2002/98/ECAnnual Report

• EU Directive 2002/98/EC -EU Member states
  required to submit an annual report by 30th June
  of each year for the preceding year
• Serious Adverse Events
• (SAE) Annex ??? Part C
• Serious Adverse Reactions (SAR)Annex ?? Part D
• NHO collated reports for 2006 ? submitted to
  competent authority Irish Medicines Board (IMB)

• applies to
• Red cells
• White cells
• Platelets
• Plasma
• Whole blood
• Other e.g granulocytes, cryoprecipitate

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EU Directive annual notification of Serious
Adverse Events Reactions (ANSAR/E)

• ANSAR/E data may differ from NHO data
• EU Directive does not cover clinical errors
• some cases have on review have been
  recategorised (2006 not submitted to EU)

• Does not apply to blood products.
• SARs and SAEs related to SD plasma not
  reportable under EU Directive -but NHO collects
  reactions on ANSAR/E

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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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Reactions reported for Annual Notification 2006
(N112)
N.B some cases involved multiple components.
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What SARs were reported? Red blood cells

• Total number of reactions 86
• One death
• (possibly related to transfusion)
• Immunological haemolyis due to other
  allo-antibody 5
• Anaphylaxis/ hypersensitivity 9
• Transfusion Related Acute Lung Injury (TRALI) 2
• Viral 5

• Other serious reactions 65
• These included
• Febrile Non-Haemolytic Transfusion Reaction
• TACO involved ANSAR/E )
• Unclassified
• NB some of these cases involved multiple
  components.

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What SARs were reported?platelets

• Total number of reactions 29
• Anaphylaxis/
• hypersensivity 19
• Transfusion-transmitted bacterial infection 2
• Other serious reactions 8

• These included
• FNHTR 7 (one case involved multiple components)
• TACO 1
• (one case involved multiple components)

Only one reaction reported Whole Blood- FNHTR
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2006 Reactions Reported comparison for ANSAR
and to NHO

• 1 TTI with SD Plasma, not reportable for ANSAR/E
• Some of these associated with multiple components
• Immunological haemolysis 3 DHTR 2 AHOSTR
• (1 serological DHTR reported to NHO not
  reportable under ANSAR/E )

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Imputability

• Reporters must determine the likelihood a
  serious adverse reaction in a recipient is due to
  the blood/blood component.
• levels included in NHO handbook, NHO
  questionnaires and on ANSAR/E form.
• determined by hospital-any change of imputability
  NHO notifies hospital by letter.

• Only serious adverse reactions of imputability
  level 2 or 3 attributable to the quality and
  safety of the blood need to be reported to the
  competent authority.
• Can cause difficulty but if a case is reported
  as a level 2 or 3 and subsequently down-graded it
  must be included on the ANSAR/E

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Imputability of reactions (N112 )
N.B Some reactions involved multiple components
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Serious Adverse Events (SAE)

• Confusion over what SAEs reportable.
• Only report events occurring with transfused
  components
• e.g. SAEs associated with testing but not
  transfused not reportable.
• Blood establishments completed all areas of the
  SAE table.
• Blood banks completed highlighted areas.
• If a patient had a reaction as a result of an
  SAE captured as an SAR if no reaction -
  recorded as a SAE

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Breakdown of SAE (N32)
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Testing of donations

• Compatibility testing is considered to fall
  within the term testing - includes adverse
  events caused by testing failures, failure of
  equipment.
• Examples include
• on- call staff incorrectly grouped
  patients,
• or blood group given on results of first
  spin
• Re-spun and different result obtained.
• One was due to the introduction of new
  technology where donor
• was previously grouped Kell neg- then
  Kell pos.
• Several SAEs reported under testingrecategoris
  ed e.g. failure to select antigen negative or
  Rhesus negative component

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SAES STORAGE

• involves all stages of cold chain including
  storage in the laboratory/satellite fridges.
• e.g components out of controlled storage
  beyond recommended time returned to fridge and
  subsequently transfused.

• most of these cases involved removal of component
  from controlled storage in excess of recommended
  time returned to fridge and transfused.
• Others storage errors included placing component
  in wrong fridge.

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SAEs OTHER

• SAEs affecting the quality and safety of the
  blood or blood component not covered by the above
  categories but occurring within the Hospital
  Blood Bank.
• Includes selection of blood for special
  requirements, e.g. specific patient requirements
  such as blood suitable for exchange transfusions.

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SAEs OTHER

• Other (must be specified)
• (Human error) 16 cases reported.
• These included
• failure to select CMV negative component.
• failure to select Rhesus negative or antigen
  negative components.
• transfusion of expired components
• (should not have been available for
  transfusion)
• incorrect labelling of component

• .

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Reporting of SAEs

• Processing does not apply to hospital blood
  banks.
• Blood establishments reported the number of
  units processed.
• Processing errors
• Human error -
• 1 case -blood establishment issued
  non-irradiated component.

• Materials - A hospital blood bank should report
  SAEs relating to a deviation in materials in
  association with testing, storage and
  distribution.
• no SAEs associated with materials reported.

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REPORTING OF SAEs

• Distribution The act of issuing blood and blood
  components to other blood establishments,
  hospital blood banks and manufacturers of blood
  and plasma derived products.
• Does not include issuing of blood or blood
  components from hospital blood banks for
  transfusion.
• Blood banks reported number of units issued
  to clinical areas for transfusion.
• No SAEs reported associated with distribution.
• Paedipacks should be included with red cells
  and counted as 1 recipient irrespective of number
  of aliquots

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Problems encountered Reporting SAE

• Number of units issued- no. of components issued
  from the laboratory included transfused
  clinical wastage.
• Note did not include number of
  cross-matches done in laboratory (many hospitals
  did include cross-matches ? resubmitted)
• Number of recipients transfused-no of patients
  transfused ( if available many LIS unable to
  provide this figure)
• Note if a patient admitted several times
  in one year counted only once- not at each
  admission.
• Number of units transfused-
• (if available)- no. of units transfused-
  (excluded wastage). Some LIS could not provide
  this.

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IBTS issues versus issues reported on ANSAR/E 2006
Hospital Issues for cryoprecipitate
FFP very similar to IBTS issues (not
shown)
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Next year?

• NHO currently developing online reporting for
  annual notification.
• Hospital HVO will complete online- will receive
  acknowledgement of receipt from NHO.
• Alternatively complete excel spreadsheet
  submit electronically to NHO.
• Manual facility will also be available.
• Hospitals may be asked to submit HV numbers for
  cases entered on form to facilitate
  reconciliation.

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Conclusion- uses of data

• Reports on incidence of SARs versus units
  transfused, or number of recipients transfused
  (previously unavailable).
• Reports for each hospital and by hospital
  category.
• Data on size of hospital versus blood usage.
• Reports by reaction and what events reported. e.g
  SAE related to storage.
• Will be able to compare reports on a year on year
  basis.
• Forms will be issued in January 2008 for 2007-
  to be returned by given date as IMB must report
  to EU 30th June -.
• Thanks hospitals, NHO colleagues Maria
  Flanagan (IBTS) IMB