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The Aintree Approach to Transfusion Incident Management _CMc JG_


									         Christine McQuillian
(Transfusion Laboratory Manager-TLM)
               Jan Gorry
     (Transfusion Practitioner-TP)
To share and discuss our Incident
reporting policy cited as best practice at
MHRA and CPA inspections

To explain how we investigate incidents

To demonstrate our tracking and trending
Aintree is a 1000 bedded acute
Foundation Hospital which also provides
transfusion services to The Walton Centre,
and The Women s Aintree site, plus a
private hospital and dialysis unit.
In total we transfuse 10-11,000 red cells
per year, and around 1,800-1,900 platelets
and FFP.
We process 23,000 group and screens.
All staff have a duty to report transfusion
incidents and near misses regardless of the
impact on the person involved.
The member of staff who connects the pack is
responsible for reviewing the observations to
detect a possible transfusion reaction.
The clinician who is asked to manage a
suspected reaction is responsible for reporting
the reaction to the Transfusion Department
Any person who discovers a transfusion near-
miss or adverse event is responsible for
reporting it to the transfusion department.
The TP or TLM is responsible for logging the
incident on the incident record sheet.
The TP is responsible for investigation of clinical
reports / logging in Q-Pulse/ external reporting
The TLM is responsible for investigation of
laboratory reports / logging in Q-Pulse/ external
The Transfusion Team are responsible for
reviewing and categorising serious reports
The TP is responsible for correlating all
reports into a risk report on a quarterly
basis-reviewed at HTC and by the Trust
Risk Group.
Trust clinical incident (DATIX) reports are
also completed for serious reports
(SAR/SAE and SHOT incidents/NM).
Serious adverse reaction (SAR)
Serious adverse event (SAE)
SHOT near miss
Minor non compliance (MNC)- For example on wards
this would be a missing traceability record or failure to
follow procedure. For the laboratory this would for
example be a minor data entry error, or failure to spot a
sample labelling error at first check.
Quality Incident (QI) examples: communication
problems, QC problems, equipment problems, failure to
follow procedure etc
Blood storage
Wrong blood in tube
Erroneous sample
Erroneous request
Labelling error
Data entry
Laboratory process
Collection/ administration
             QI, MNC, SHOT NM, SAR, SAE reported to
                      Transfusion Department

   Incident is logged via Transfusion Department Incident Record
   Sheet and also the QPulse Compliance and Improvement
   Management System.

         Incident categorised and discussed by HTT.

    SHOT NM            SAE             SAR            MNC
                                                      or QI

    Report to SHOT /SABRE via SABRE                      Report to Clinical
                 Website                            Governance / Clinical Risk
                                                   dept via Risk complaints and
                                                   Quarterly Report, Standards
                                                   for Better Health Report, and
                                                   Clinical Risk Working Group

Corrective procedures actioned via HTT liaising with HTC/ Clinical Risk/
                     Clinical Governance Groups

Corrective actions logged via QPulse Management System.
2 no-harm events where blood was issued
after the sample had passed 72 hours
valid time.
One no harm event when blood was
issued and transfused to a patient which
should have been E negative (the patient
did not have Anti-E)
An antibody identification panel was used
for testing after the expiry date.
                        Summary of Transfusion Errors Between 01/01/08 and 31/03/08

                                                                                                         Lab Testing
       90%                                                               3
% of Error Category

                                                                                                         Collection / Administration
       80%                                11
                            4                              1                                             Blood Storage
                                                                                                         Wrong Blood in Tube
       60%                                                               4
                                                                                                         Erroneous Sample
       50%                                10                                                             Erroneous Request
       40%                                                               2
       30%                                                               1
                            4                              1                                             Requirement
                                                                         2                               Data Entry
       10%                                 6
                      Lab Minor Non- Ward Minor Non- Lab SHOT Near   Ward SHOT   Lab SHOT    Ward SHOT
                        compliance     compliance         Miss       Near Miss    Incident    Incident

                                                        Error Category
                            Laboratory Incidents Jan 09 - Mar 09

                 Supplier Error, 1
                                        Haem Cover Communication, 3

                                                                               Haem Cover Communication
Chart Error, 5                                     Compliment, 1
                                                                               Batch Product
                                                                               Transfer Problem
                                                        Batch Product, 2
                                                                               Process Error
                                                                               Data Entry
                                                                               Chart Error
                                                         Transfer Problem, 1
                                                                               Supplier Error

Data Entry, 5

                                           Process Error, 6
SHOT near miss:
38% Laboratory / 62% Clinical areas

36% Laboratory / 64% Clinical areas
Comprehensive policy and process
Local investigation and review
Means that hopefully we have a good idea
where our risks/problems are and where
we need to concentrate scarce resources.
Inspectors saw evidence that the Trust
responds to risks which HTT escalated.
MHRA Inspector commented that the
incident sheet sometimes lacked sufficient
As a learning point we now copy and keep
all associated documents with incident
140                                  126          transfusion 'SHOT
                                                  incident' (or SAE from
120                                               2006)
100                                               near-miss
 80                       75    72
                   39                      48     minor non-compliance
 40         26                                    or quality issue
 20 7      7      8
                         1      3    4
    2003   2004   2005   2006   2007 2008
Sample received details on request form
(addressograph) and sample bottle
(handwritten) match
Sample processed grouped A RhD Pos
Historical record 0 RhD Pos
Second sample requested 0 RhD Pos
Wrong Blood in Tube (WBIT)
                            Establish who took
                            Visit staff/area involved
                            Discuss events which led
                            to mistake
                            Sample taken the labelled
                            remotely from patient
                            using incorrect details on
                            request form
                            Breach of TRUST
                            POLICY identified

Incident Form Completed
SHOT NEAR MISS (category)
Recommend attend
venepuncture update
NPSA Competency
Importance of correct
procedure as per
Trust Policy
Incident highlighted to
Line Manager and
Clinical Risk Lead
Q Pulse Completed             Datix Completed
Unique Ref Number Generated

                               Copy sent to Clinical Risk Lead
Discussed at HTT & HTC Actions formulated
Highlighted at Clinical Risk Group Meetings
Copy sent to Clinical Risk & Clinical Governance
Devised Safety Posters for Trust wide distribution
Added to Induction & Mandatory training Sessions
Lesson of the Month July 2008
On going education/awareness
NPSA Competency assessments ongoing
Suspected TRALI - this involved a patient transferred
from affiliated Trust to ITU at UHA with ARDS within
24hours of having a transfusion (6units RBC).
Confirmed platelet reaction involving a patient who
displayed signs of a reaction after approximately 50mls
were transfused
Delayed Transfusion Reaction patient was admitted
one week post transfusion of 4 units RBC with sudden
onset jaundice and haematuria. Symptoms were
consistent with a (DTR). This type of reaction is
recognised as an unavoidable risk of transfusion, where
an antibody developed in the past drops to levels
undetectable in laboratory tests.
Quarter on quarter, year on year trending
would be useful.
Plan to amend incident form to match
Q-Pulse data entry.

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