Meeting Traceability Requirements

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Meeting Traceability Requirements

• Gerry Judge

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Article 14 Traceability

• 1 Member states shall take all necessary
  measures in order to ensure that all blood and
  blood components collected, tested, processed
  stored, released and/or distributed on their
  territory can be traced from donor to recipient
  and vice versa.
• 3. Data needed for full traceability in
  accordance with this Article shall be kept for at
  least 30 years
• The Directive is law and we have to adhere to it
  now.
• Traceability is Law since end of August 2006
• The method of assessing our compliance with these
  laws is through Accreditation.
• IMB and INAB published Minimum Requirements for
  Blood Bank Compliance with Article
  14(Traceability) and Article 15(Notification of
  Serious Adverse Reactions and Events) of EU
  Directive 2002/98/EC

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Details that have to be kept

• Blood component supplier identification
• Issued blood component identification
• Transfused recipient identification
• For units not transfused, confirmation of
  subsequent disposition
• Date of Transfusion/disposition
  (year/month/day)
• Lot number of component
• Identity of person witnessing the transfusion

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What this means is-

• Have to be able to give the full history of a
  unit of blood or component
• Transport
• Storage
• Documentation
• Validated equipment
• Final fate
• 30 years
• At all stages blood bank management requirements
  need to be in place e.g. SOP, training records

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1.Order it from Establishment

• Usually by phone
• Need a list of who can order
• Document the units ordered

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2.Transport from Establishment

• Routine delivery IBTS van
• Emergency often taxi Garda escort in
  emergency.
• Private ambulance
• Validated systems

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3. Receipt

• Some labs use the IBTS delivery docket and
  date/time stamp
• Others stamp delivery docket and fill in details
• Need a visual check on units

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4. Stock entry

• Entered into stock
• Book or ledger e.g if no computer
• Placed in stock fridge- Is the fridge at correct
  temp?
• Computer

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Stock entry
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5. Storage

• Fridges/Freezers
• Validated
• Temp mapped
• Theatre

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6. Selection of blood for Compatibility testing

• Policy needs to be defined
• Group specific
• Emergency O Neg
• Compatability SOPs will cover this
• Giving platelets changing groups

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8. Labelling

• Labelling blood very critical
• Clear and uncluttered area.
• Double check label
• All documented in SOP

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7. Release and Issuing

• Compatibility results negative
• This is usually performed as an authorisation
  step on computer

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9. Request to clinical area

• Phone call or bleep to porter
• Printout in porters office or in lab
• Paper request from ward
• Electronic request
• Blood has to be signed out

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10. Transport within hospital

• Various transport boxes
• 30 min rule

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11. Quarantine

• Need a quarantine fridge.
• Blood not for use should go to this fridge e.g.
  recall, out of fridge too long

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14. Release to clinical area

• Who is allowed to collect blood
• Password or swipe controlled

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12. Sending blood with patient

• To another hospital
• Validated container
• See Academy guidelines
• Documentation sent with units
• SOP required

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13. Blood Component administration

• SOP on administration Prescription
• Pre trans checks etc
• Pre transfusion obs
• Transfusion commenced

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16 Traceability in clinical area

• Need to know name of patient that got blood and
  document it in Blood Bank
• Number of ways of doing this

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Traceability in clinical area

• Personally
• go to ward and get the details
• Electronically
• Method of choice. Units are wanded at bedside and
  details sent back to lab.
• traceability and safety
• wanding at station

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Traceability in clinical area

• Manual paper based
• paper with unit and patient details filled in on
  ward and sent back to Blood Bank

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Traceability

• Detachable label on blood pack
• Nurse signs it and leavesin box at station
• Porter collects every day
• Lab wands into computer
• Label is attached to signout
• Keep for 30yrs?

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Traceability contd

• Manual system a stopgap while awaiting electronic
  system
• Lots of bits of paper to mind
• Legally only IBTS product master file need to be
  tracked but we tract all products
• Compliance is good Nurse practice did a lot of
  training
• If not signed we check chart

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17 Traceability of blood transferred with patient

• Receiving hospital to inform sending hospital of
  fate of unit
• Can be difficult cause sometimes lab is not
  informed

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15 Return of blood/components to inventory

• Was the blood stored properly while assigned to a
  patient?
• How long was it held?
• SOP required

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18 Traceability in Hospital Blood Bank

• Auto used switched off
• Traceability labels
• Discards
• Blood sent with patient
• Expired blood or platelets
• Blood returned to IBTS
• Need a system of reconciling stock received with
  fate or status
• Check computer inventory for units not fated

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19 Disposal of used packs

• What happens the used blood packs
• disposed with clinical waste
• some labs get them back and dispose with Blood
  Bank waste
• Need an sop

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• Time to bin this talk all we have to do now is
  wait for the assessor!
• Thank you