Article 15 Explained

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Article 15 Explained!

• Marina Cronin
• National Haemovigilance Office

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• Member States shall ensure that those facilities
  where transfusion occurs..notify blood
  establishments without delay of any serious
  adverse reactions observed in recipients during
  or after transfusion which may be attributable to
  the quality or safety of blood and blood
  components.
• (Directive 2005/61/EC Article 5)

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• Member States shall ensure that reporting
  establishments have procedures in place to
  communicate to the competent authority as soon
  as known all relevant information about
  serious adverse events which may put in danger
  donors or recipients other than those directly
  involved in the event concerned. (Directive
  2005/61/EC Article 6)

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Article 15 tells you

• What to report?
• To whom are you reporting?
• When to report?

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Serious Adverse Reaction

• An unintended response in the patient associated
  with the collection or transfusion of blood and
  blood component that
• Is fatal
• Is life-threatening
• Causes disabling or incapacitating conditions for
  patients
• Results in, or prolongs, hospitalisation or
  morbidity

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Immunological haemolysis (I)

• Post transfusion RCC destruction following immune
  response
• As a result of
• ABO incompatability
• Other alloantibody
• Acute -lt 24 hours
• Delayed -gt 24 hours

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Immunological haemolysis (II)

• NHO- Acute Haemolytic Transfusion Reaction
• Defined as reaction occurring within 24hrs of
  transfusion where clinical and/or laboratory
  features of haemolysis are present

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Delayed Haemolytic Transfusion Reaction (DHTR)

• Defined as evidence of clinical or laboratory
  features of haemolysis occurring more than 24
  hours following the transfusion of a blood
  component.
• Associated with evidence of red cell antibodies.
• (ISBT, Capetown, 2006)
• Red cell antibodies detected over a month after
  transfusion without evidence of haemolysis are
  termed delayed serological reactions
• not reportable to National Haemovigilance Office

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Immunological haemolysis - due to other
alloantibody

• Usually Delayed Transfusion Reaction
• Haemolysis due to other incompatible antigen e.g.
  anti Rh, Kell or Jka antibodies.
• lt 24 hours- usually as a result of poor antibody
  screening technique

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Non- Immunological Haemolysis

• Haemolysis as a result of other causes
• drugs mixed with the blood component,
• mechanical factors, malfunction of a pump, blood
  warmer etc
• NHO -Acute Haemolytic Transfusion Reaction

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Transfusion transmitted bacterial infection

• Incorporates reports of suspected bacterial TTIs-
  definitions unchanged
• Following careful clinical review- subject to
  RAPID ALERT NOTIFICATION
• Contact IBTS / supplier immediately

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Anaphylaxis /Hypersensitivity

• NHO - Acute Allergic and Anaphylactic Reaction
  (AA)
• AA reactions span a range of symptoms of varying
  severity
• Stridor
• Wheeze
• Angioedema
• Bronchospasm
• Hypotension
• Anaphylactic reaction (anaphylaxis) severe
  hypotension collapse /- laryngeal oedema
  respiratory obstruction

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Transfusion Related Acute Lung Injury

• Characterised by acute respiratory distress, with
  bilateral pulmonary oedema but no evidence of
  cardiac failure or fluid overload
• Symptoms typically begin within 1-2 hrs of
  transfusion and always within 6 hrs
• Canadian Consensus Conference suggests that TRALI
  incidents be divided into TRALI and possible
  TRALI
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  (Kleinman et al, 2004)

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TRALI characteristics

• Acute onset of symptoms
• Hypoxemia SpO2 lt 90 on room air or other
  evidence of hypoxemia
• Bilateral infiltrates on frontal chest X-ray

• No evidence of circulatory overload
• No pre-existing acute lung injury (ALI) before,
  during, or within six hrs of transfusion
• No alternative risk factors for Acute Lung Injury
  present

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Possible TRALI

• is characterised by the following
• ALI as described above
• No pre-existing ALI before, during, or within six
  hrs of transfusion
• Presence of alternative risk factors for Acute
  Lung Injury (see handbook)

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TRALI

• Following careful clinical review - subject to
  RAPID ALERT NOTIFICATION
• Contact IBTS / supplier immediately

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TRALI (I)

• Confirmation only following clinical assessement
  and donor investigations

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TRALI Investigations carried out by IBTS

• Patient HLA investigations
• Donor HLA investigations
• Donor granulocyte investigations

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Suspected Transfusion Transmitted Infection

• Post transfusion infection is confirmed as
  transfusion-transmitted once investigations are
  complete and the following criteria are fulfilled
• 
  
• 
  
  (SHOT, 1999)
• Recipient shows evidence of infection following
  transfusion, with no evidence of infection prior
  to the transfusion
• And either
• A donor who had evidence of the same
  transmissible infection, donated at least one
  component received by the infected recipient
• Or
• At least one component received by the infected
  recipient was shown to have been contaminated
  with the same infectious agent

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Suspected Transfusion Transmitted Infection

• The NHO collects and investigates reports on the
  following
• All suspected transfusion-transmitted viral
  infections relating to blood components which
  have been transfused after the introduction of
  mandatory testing for that virus i.e. HIV 1 2,
  HCV, HBV, HTLV III.
• Viral infections which not covered by mandatory
  testing, e.g. Hepatitis A virus, CMV and
  Parvovirus, but which are suspected to be
  associated with a blood transfusion.
• Transfusion-transmitted bacterial and parasitic
  infections i.e. Malaria, toxoplasmosis.

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Transfusion transmitted viral parasitical
infection

• Incorporates reports of suspected TTIs-
  definitions unchanged
• Following careful clinical review - subject to
  RAPID ALERT NOTIFICATION
• Contact IBTS / supplier immediately

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Transfusion transmitted infection
Investigations carried out by IBTS

• No. of donors implicated
• Donor investigations

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Post transfusion purpura Graft V Host Disease

• Incorporates reports of above reactions -
  definitions unchanged

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Transfusion Associated Circulatory Overload

• Reported under the Directive as other serious
  reaction
• Acute pulmonary oedema secondary to congestive
  cardiac failureusually manifesting during/within
  6 hrs of completion of transfusion

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Febrile non haemolytic transfusion reactions
(FNHTR)

• Defined as fever of gt1.5oC than normal baseline
  value
• together with
• rigors or chills, occurring during or within four
  hours following transfusion may be accompanied
  by other symptoms e.g headache, nausea
• and
• where symptoms lead to morbidity or prolonged
  hospitalisation for patients
• without
• any other cause such as haemolytic transfusion
  reaction, bacterial contamination or underlying
  condition

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Previously Unreported Complication of
Transfusion (PUCT)

• Defined as the occurrence of an adverse effect or
  reaction temporally related to transfusion which
  cannot be classified according to an already
  defined Adverse Transfusion Events and with no
  risk factor other than transfusion
• 
  (ISBT Working Party,2006)
• Reported within Other category

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Adverse reactions not generally reportable to NHO

• Simple febrile reactions with no related symptoms
• Simple urticaria, pruritis, rash

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Imputability

• . the likelihood that a serious adverse reaction
  in a recipient can be attributed to the blood or
  blood component transfused or that a serious
  adverse reaction in a donor can be attributed to
  the donation
• (Directive 2005/61/EC Article 1)
• Must determine Imputability of SAR
• (Directive 2005/61/EC Article 5)

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Evaluating SAR
Directive 2005/61/EC Annex 2 Part B
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Serious Adverse Event

• Any untoward occurrence associated with the
  collecting, testing, processing, storage and
  distribution of blood and blood components that
  might
• Lead to death
• Be life-threatening
• Cause disabling or incapacitating conditions
• Result in, or prolong, hospitalisation or
  morbidity

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EU Directive Serious Adverse Events

• Covers errors associated with storage and
  distribution
• Distribution does not cover issue for
  transfusion within hospital (covers supply
  centre to hospital)
• ABO incompatible without reaction
• no mandatory requirement to report to EU, but
  reportable to NHO
• Mandatory where associated with haemolytic
  reaction
• However INAB accreditation will require evidence
  of serious adverse event collection and
  reporting to NHO

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NHO Serious Adverse Events

• NHO will continue to collect
• Incorrect Blood Component Transfused (IBCT)
• IBCT Incidents involving Anti D Immunoglobulin
  or Factor Concentrates

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• IBCT
• The transfusion of a blood component/product
  which did not meet appropriate requirements
  and/or was intended for another patient
• IBCT Anti D and Factor Concentrates
• Incidents involving errors, delays or omissions
  relating to Anti D or Factor Concentrates

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Examples of reportable IBCT

• ABO incompatible transfusions
• (with or without reaction)
• Wrong blood to wrong patient
• (even when found to be ABO and Rh D
  compatible)
• Sample/identification errors resulting in wrong
  transfusion
• Rh positive RCC given to a woman of child bearing
  potential or
• Rh D positive components administered to a
  Rh D negative patient in error
• Failure to give antigen negative blood to patient
  with known antibodies
• Transposition of crossmatch labels
• Between patients
  (level 1)
• Within
  crossmatch (level 2)

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Examples of reportable IBCT (II)

• Failure to give CMV negative or irradiated blood
  components where required
• Errors surrounding collection, storage or
  improper handling of blood
• Spiked unit returned to fridge and subsequently
  transfused
• Blood stored in ward fridge
• Transfusion of RCC which were returned to storage
  having been out for over 30 mins
• Wrong giving set used
• Other fluids (apart from saline) or drugs
  transfused with blood component through same line
• Transfusion time exceeded
• Expired units transfused where commenced after
  expiry time
• Inappropriate use of mechanical devices pumps etc
• Components administered too quickly to at-risk
  patients

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Examples of reportable IBCT (III)

• Transfusion of blood components/products, which
  were not necessary (due to errors in clinical
  decision-making or incorrect laboratory results).

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Pre-Deposit Autologous Donor Incidents

• defined as an adverse or unforeseen event,
  experienced by donor during or following a
  pre-deposit autologous donation (PAD) procedure
• Note Institutions undertaking PAD are Blood
  Establishments and reporting of serious adverse
  events is mandatory

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• To whom are you reporting?

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Hospital Blood Bank
Clinical and Lab HVO
Haematologist
Individual Serious Adverse Reactions and
Events Currently captured by NHO
Annual Report of Serious Adverse Reactions
EU reportable
SAR SAE
NHO
IMB

EU
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When to report?

• As SAR and SAE occur unchanged
• Rapid Alert unchanged
• Annual basis CHANGED

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Timelines for reporting

• SARs and SAEs (as covered by Directive) occurring
  after Nov 2005 accepted at any time
• SAEs /IBCTs (not included in Directive) within
  one year

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• SARs involving SD Plasma
• Report to NHO (not covered by EU Directive)
• NHO will forward to IMB and manufacturer
• SAEs relating to SD plasma
• Report to NHO (not covered by EU Directive)
• Treated as IBCT
• SARs (Anti D and Factor Concentrates)
• Report directly to IMB (not covered by EU
  Directive)
• SAEs (Anti D and Factor Concentrates)
• Treated as IBCT (not covered by EU Directive)

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Annual Notification Form

• Annual report to competent authority (Articles 5
  6, Directive 2005/61/EC)
• Issued from NHO in January
• Captures reports of SAR and SAE collected during
  preceding year, reportable under Directive
• Competent Authority submits report to EU by 30
  June (Article 8 Directive 2005/61/EC)

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In conclusion

• What to report
• SAR and SAE as outlined
• To whom are you reporting
• NHO -IMB -EU
• When to report 3 timelines,
• Usual
• Rapid Alert
• Annually

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In conclusion

• Handbook Currently under review by IMB

thank you