Documentation and Traceability

Documentation of Transfusions and Inventory for Traceability

There is a requirement that ALL donations of blood can be traced from the donor to the final fate of the product/component. Essentially this means that no matter how many products and components ARCBS makes from a donation each part MUST be traceable to its fate, even if the fate is that it is destroyed unused.

Documentation of the Decision, Consent, Request, and the Transfusion Episode

Good documentation of transfusions allows easy and accurate review of records when required, for reasons such as:

  • Investigation of a transfusion-related adverse event,
  • Facilitating donor and recipient ‘look back’ exercises,
  • Performance of quality improvement audits,
  • Management of legal risk (1),(2).

The following is recommended:

  • The prescribing doctor should document the transfusion decision rationale (based on recognised clinical practice guidelines) in the medical notes. This should detail the outcome of the informed consent process. Patients should be informed of the potential benefits and risks of transfusion in their particular case and their right to receive or refuse it. This decision should also be recorded.
  • The prescription for blood and blood components is the responsibility of a doctor. The prescription should be documented and specify the blood or blood components to be administered, the quantity, the duration of transfusion and any special requirements.
  • A permanent record of the transfusion episode should be kept in the medical notes, including the following:
    • the blood transfusion record which includes:
      - date and time transfusion commenced and completed
      - type of blood component usednumber of units transfused
      - donation/batch number
      - signature of person administering the transfusion
      - signature of person confirming the identity of the patient
    • the sheets used for the prescription of blood or blood components
    • nursing observations during the transfusion
    • whether or not the transfusion achieved the anticipated benefit
    • management of any adverse events.
  • All records must be held for the required legislated period.

ARCBS recommends you set a laboratory/hospital policy based on the highest standards that you use for the storage of medical records within your facility. This requirement will vary between states and territories.

Documentation of Inventory

In addition to transfusion records you must also keep an inventory record of products received and their fate so that the final whereabouts of all products and components is known.
It is suggested you maintain an inventory register to record receipts of products/components and what their fate is.

Data collected should include:

  • Product
  • Unique or Batch Number
  • Blood Group (if applicable)
  • Expiry Date
  • Date received
  • Fate of item (transfused with patients name, wasted with reason, sent to where etc)
  • Date fate applied

Traceability and the ARCBS

Occasionally donors who were well when they donated subsequently inform ARCBS that they have developed symptoms of a disease state.

Usually this is not a problem but certain diseases can be of concern. The ARCBS endeavours to locate the fate of units donated by any potentially harmful donation and where possible (and time permits) quarantine the item(s) so they are not transfused pending further tests.

Occasionally it may be necessary to trace the recipients of the donations and offer them medical advice.

ARCBS can only achieve this through the availability of well maintained records showing receipt and fate of products/components.

References

(1) Circular of Information - An Extension of Blood Component Labels, 2007. Published by ARCBS 2007.

(2) AHMAC Blood and Blood Products Committee - Commonwealth Department of Health and Aged Care, Review of the Alternatives to Homologous Blood Donation, June, 2000, Australia.