Traceability

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Traceability

• G. Judge
• Academy of Medical Laboratory Science Adelaide
  Meath NCH

2
EU Directive
Parliament council
Mother Directive
Daughter Directive
Commission
3
Directive 2002/98/EC

• Quality and safety human blood and blood
  components

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Draft commission Directive ..//EC of
implementing directive 2002/98/ECArticle 2
Traceability

• Member states shall ensure the traceability of
  blood and blood components through accurate
  identification procedures, record maintenance and
  an appropriate labelling system
• that the traceability system in place in the
  blood establishment enables the tracing of blood
  components to their location and processing
  stage.
• .that every blood establishment has a system in
  place to uniquely identify each donor, each
  blood unit collected and each blood component
  prepared, whatever its intended purpose, and the
  facilities to which a given blood component has
  been delivered
• ..that all facilities have a system in place to
  record each blood unit or blood component
  received, whether or not locally processed, and
  the final destination of that received unit
  whether transfused discarded or returned to the
  distributing blood establishment.
• ..that every blood establishment has a unique
  identifier that enables it to be precisely linked
  to each unit of blood that it has collected and
  to each blood component it has prepared.

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Establishment
Red cellsPlateletsPlasmaCryo
Tracing within establishment to component
processing Accurate identification, records, and
labelling

• Record of data on traceability to keep
• Establishment identification
• Blood donor identification
• Component identification
• Date of collection
• Facility sent to

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Establishments

• Article 7
• Member states shall ensure that for imports of
  blood and blood components from third-country
  blood establishments have a system of
  traceability in place equivalent to that provided
  for in Article2(2) to 5

• Article 2(3) to uniquely identify each
  donor
• Imported Plasma from USA Each lot (batch) of
  Octoplas can have 1700 2000 donors

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Number of units to be tracked

• Non IBTS establishments would need to look at
  level of documentation required
  

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Hospital
Verified as used on ward
Stored issue/ satellite Fridge returned discarded
Blood arrives in hospital
Check
Autoused
Matched to named patient labelled Urgent
O Neg
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Article 2 Hospital Blood Bank has in place a
system to record each blood unit or component
received final destination of the unit
transfused discarded or returned.

• Unit transfused
• Electronic
• Can it handle components with lot numbers?
• interfaces with laboratory system?
• Unique donation number
• Paper
• Label or form to match up
• Transfusion record
• Can it be scanned in?

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Article 3 or the hospital blood bank has in
place a procedure to Verify that each unit has
been transfused to its intended recipient or if
not transfused to verify its subsequent
disposition

• establish the truth or correctness of ..
• Chart
• Prescription
• Patient obs
• signatures
• Paperwork in massive transfusion
• Electronically

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Article 4Member states shall ensure that blood
establishments, hospital blood banks, or
facilities retain the data set out in Annex I for
at least 30 years in an appropriate and readable
storage medium in order to ensure traceability

• Annex I
• Blood component supplier identification
• Issued blood component identification
• Transfused recipient identification
• For blood units not transfused, confirmation of
  subsequent disposition
• Date of disposition (year/month/day)
• Lot number of the component if relevant

• Storage medium
• Laboratory computer
• Transfer of data from old to new computer
• Manual records
• All data does not have to be stored in same area
  
• Charts
• Destruction Policy

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Conclusion

• Establishments
• Level of documentation required by non IBTS
• Donor information on imported products
• Hospitals
• Incoming stock documentation
• stock reconciliation
• Record fate of unit
• Verify fate of unit
• Store information for 30 years
• Entry into force - not yet!
• END