National Haemovigilance Office working within the EU Directive

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National Haemovigilance Office- working within
the EU Directive

• Marcia Kirwan
• NHO Haemovigilance Officer
• May 2005

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Haemovigilance defined as

• A set of organised surveillance procedures,
  relating to serious adverse events or unexpected
  events or reactions in donors or recipients and
  the epidemiological follow up of donors
• EU Directive 2002/98/EC

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Remit of NHO

• Receive, collate and follow up reports of adverse
  reactions and events, and provide analysis and
  feedback
• Support training of hospital based haemovigilance
  staff
• Advise on best transfusion practice and
  guidelines
• Support the training of clinical staff at
  hospital level in best transfusion practice
• Support the audit function of hospitals in
  relation to transfusion
• Report quarterly to IMB

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Focus of Directive

• On collating and reporting function of NHO
• On reporting relationship of NHO with IMB
• Other functions are ongoing - but not directly
  referred to by the directive!

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Reporting System
Adverse Transfusion Reaction/Event
Hospital TSO/Lab investigation
Hospital Transfusion Committee Consultant
Haematologist
NHO
Feedback
IMB
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EC Directive 2002/98/EC

• Article 15Member states shall ensure that...
• .any serious adverse reactions observed during
  or after transfusion which can be attributed to
  the quality and safety of the blood are notified
  to the competent authority ie serious adverse
  reactions notification mandatory
• Serious Adverse events (Accidents and Errors)
  related to the collection, testing,processing,stor
  age and distribution of blood affecting quality
  and safety are also notifiable but distribution
  means delivery not issuing of blood and therefore
  does not apply at hospital level

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Events/Reactions

• Severe Adverse Events
• Incorrect Blood Component Transfused
• Transfusion Associated Circulatory Overload

• Severe Reactions
• Acute haemolytic or other severe acute
  transfusion reactions
• Allergic/Anaphylactoid
• Transfusion Related Acute Lung Injury
• Delayed Haemolytic
• Post Transfusion Purpura
• Suspected Transfusion Transmitted Infections
• Graft Versus Host Disease
• Other

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Events/Reactions 2003
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Events/Reactions 2003 (as categorised by EU
Directive 2005)
No patient reaction Not mandatory Not
confirmed
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Events/Reactions 2003
TRALI (1)
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Changes to reporting Reactions

• Reporting of serious adverse reactions is
  mandatory
• Additional simple forms, incorporated in NHO
  forms, to be completed at hospital level and
  submitted
• The competent authority have advised us
• that traceability is to be maintained therefore
  patient identifiers will be required
• that both paper records and database records must
  be maintained for 30 years

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Changes to Reporting Serious Adverse Events

• Mandatory reporting of those events which relate
  to the quality and safety of the blood
• Patient and hospital identifiers required for the
  above
• Additional forms at hospital level for events
  affecting the quality and safety
• Records to be kept for 30 years on the above
• All other events no changes in NHO procedure

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Other Events

• Reporting remains a professional responsibility,
  but is not mandatory
• Anonymised system remains
• Reporting forms remain unchanged
• Details shredded on publication of the report

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In Addition

• The competent authority has advised us that all
  donor reactions must be collated by the NHO
  mandatory under directive
• All reactions occurring to autologous donors are
  reportable

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EU Directive 2002/98/EC

• Article 14 Traceability
• Member States shall take all necessary measures
  to ensure blood and blood components
  collected..released and /or distributed on their
  territory can be traced from donor to recipient
  and vice versa.
• Data needed for full traceability in accordance
  with this article shall be kept for at least 30
  years

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Implementing Traceability in Hospitals

• Decisions on implementation should be taken
  through a collaborative process involving
• Hospital management
• Consultant Haematologist
• Chief in Blood Transfusion
• Haemovigilance Officer and professional line
  manager

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• Electronic systems are advised
• Surveillance of all units by Haemovigilance
  Officer is only practicable in very low blood use
  hospitals (NHO Audit, 2004)
• In the absence of electronic systems traceability
  must be maintained at hospital level
• Consensus is required at hospital level on how to
  achieve this

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• Thank you