Annual Notification Form of EU Directive Findings 2006 by lonyoo

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									Annual Notification Form
of EU Directive
Findings 2006

      Jacqueline Sweeney
 National Haemovigilance Office



                                  1
    EU Directive 2002/98/EC
    Annual Report
   EU Directive 2002/98/EC      applies to:
    -EU Member states
    required to submit an       • Red cells
    annual report by 30th
    June of each year for the   • White cells
    preceding year              • Platelets
o   Serious Adverse Events
                                • Plasma
      (SAE) Annex ІІІ Part
    C                           • Whole blood
o   Serious Adverse Reactions   • Other e.g
    (SAR)Annex ІІ Part D
   NHO collated reports           granulocytes,
    for 2006  submitted to        cryoprecipitate
    competent authority Irish
    Medicines Board (IMB) –
                                                     2
EU Directive –annual notification of
Serious Adverse Events & Reactions
(ANSAR/E)

    ANSAR/E data may           Does not apply to
    differ from NHO             blood products.
    data:                      SAR’s and SAE’s
   EU Directive does not       related to SD plasma
    cover clinical errors       not reportable under
    some cases have on         EU Directive -but
    review have been            NHO collects
    recategorised (2006         reactions on
    not submitted to EU)        ANSAR/E



                                                       3
EU Haemovigilance-
Reporting of SAR/SAE/IBCT 2006
                 IBCT
                  123
        SAE-EU
            32

                         SAR-4; SD
                         plasma, 1
         SAR-EU          serological
         112             reaction

                         EU SAR
          SAR 5
                         EU SAE

                         IBCT (non
                         mandatory
                         reports -
                         components)
                          Reactions reported for Annual
                          Notification 2006 (N=112)
                     40
                                                                                                                                36      34
                     35

                     30                                             27
                     25

                     20

                     15

                     10
                                5
                     5                             2                            2                              3
                                                                                               1                          1                               1
                     0




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                                                                                                   N.B some cases involved multiple components.
  ae




                                                                                                                                                              5
  .h
Im
        What SAR’s were reported?
        Red blood cells
Total number of reactions = 86        Other serious reactions =65
One death                             These included:
(possibly related to transfusion)     o  Febrile Non-Haemolytic
                                        Transfusion Reaction
•   Immunological haemolyis – due     o TACO involved ANSAR/E )
    to other allo-antibody = 5        o Unclassified
•   Anaphylaxis/ hypersensitivity =   NB: some of these cases
    9                                   involved multiple components.
•   Transfusion Related Acute Lung
    Injury (TRALI) = 2
•   Viral = 5



                                                                    6
        What SAR’s were reported?
        platelets
Total number of reactions =29      These included:
 Anaphylaxis/
                                  o FNHTR 7 (one case
  hypersensivity = 19                 involved multiple
                                      components)

   Transfusion-transmitted       o   TACO 1
    bacterial infection =2            (one case involved
                                      multiple components)

   Other serious reactions = 8
                                       *Only one reaction reported
                                       Whole Blood- FNHTR

                                                                7
            2006 – Reactions Reported
            comparison for ANSAR and to NHO
                                                                                     Reactions NHO =117
40
                                                                                     Reactions ANSAR=112
35                                                                                       • 1 TTI with SD
                                                                                         Plasma, not
30                                                                                       reportable for
                                                                                         ANSAR/E
25                                                                                       •Some of these
                                                                                         associated with
20                                                                                       multiple
                                                                                         components
                                                                                         •Immunological
15                                                                                       haemolysis = 3
                                                                                         DHTR & 2
10                                                                                       AHOSTR
                                                                                         •(1 serological
5                                                                                        DHTR reported to
                                                                                         NHO not
0                                                                   .
                                                                                         reportable under
        C   O      A   LI   AA     TI           HT
                                                   R
                                                                sis             ss       ANSAR/E )
     TA         TR               ST        / FN             oly           cla
                                         TR              em             Un
                                    H OS            m .Ha
                                  AN           / Im
                                            TR
                                         DH
Imputability
   Reporters must               Only serious adverse
    determine the                 reactions of imputability
    likelihood a serious          level 2 or 3 attributable to
    adverse reaction in a         the quality and safety of
    recipient is due to the       the blood need to be
    blood/blood                   reported to the competent
    component.                    authority.
   levels included in NHO       Can cause difficulty – but
    handbook, NHO                 if a case is reported as a
    questionnaires and on         level 2 or 3 and
    ANSAR/E form.                 subsequently down-graded
                                  it must be included on the
   determined by                 ANSAR/E
    hospital-any change of
    imputability – NHO
    notifies hospital by
    letter.                                                  9
             Imputability of reactions
             (N=112 )
60                                      53


50                                                                                       Red
                                                                                         cells


40                                                                                       Platelets



30                                                                                       Whole
                                                                                         blood
                                              18
20                        16

         7                                             7
10              5               5
                                                              1

0    Excluded /unlikely   Possible   Likely/probable   Certain
                                                           N.B Some reactions involved multiple
                                                           components
       Serious Adverse Events
       (SAE)
   Confusion over what SAE’s reportable.
   Only report events occurring with transfused
    components
     e.g. SAE’s 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                                           11
     Breakdown of SAE (N=32)
16
14
                                                  Human
12                                                Error
10
8                                                 Other
6
4
2
0    Testing of   Processing   Storage   Others
     donations                                            12
       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 SAE’s reported under “testing”re:categorised e.g. failure to
    select antigen negative or Rhesus negative component
                                                                       13
       SAE’S –STORAGE
   involves all stages of cold      most of these cases
    chain including storage in        involved removal of
    the laboratory/satellite          component from
    fridges.                          controlled storage in
    e.g components out of             excess of recommended
    controlled storage beyond         time –returned to fridge
    recommended time –                and transfused.
    returned to fridge and           Others storage errors
    subsequently transfused.          included placing
                                      component in wrong
                                      fridge.


                                                             14
SAE’s –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.

                                              15
       SAE’s –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
                                                        16
      Reporting of SAE’s
   Materials - A hospital blood       Processing: does not
    bank should report SAEs             apply to hospital blood
    relating to a deviation in          banks.
    materials in association with      Blood establishments
    testing, storage and                reported the number
    distribution.                       of units “processed”.

   – no SAE’s associated with         Processing errors
    materials reported.                  Human error -
                                         1 case -blood
                                        establishment issued
                                        non-irradiated
                                        component.
                                                               17
       REPORTING OF SAE’s
   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 SAE’s reported associated with distribution.
   Paedipacks –should be included with red cells and
    counted as 1 recipient irrespective of number of
    aliquots                                        18
       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.
                                                            19
          IBTS issues versus issues
          reported on ANSAR/E 2006
                                          Red cells
                                          & whole
           138,540                        blood
                            134,378
140,000                                   Platelets
120,000
100,000
 80,000
 60,000
 40,000          20,355          19,639   *Hospital Issues for
 20,000                                    cryoprecipitate
                                           & FFP very similar
      0                                    to IBTS issues
           IBTS issues    ANSAR/E data      (not shown)




                                                                 20
        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.
                                                      21
       Conclusion- uses of data
   Reports on incidence of SAR’s 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                                               22

								
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