JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

Traceability update 2014

What is the expectation from the MHRA in relation to those occasions when return of crossmatch labels, namely traceability, is below the required 100%?

The UK Blood Safety and Quality Regulations 2005 (as amended) defines “traceability” as “the ability to trace each individual unit of blood or blood component from the donor to its final destination (whether this is a recipient, a manufacturer of medicinal products or disposal) and from its final destination back to the donor”. The Regulations place an obligation upon both Blood Establishments (regulation 8) and hospital blood banks (regulation 9) “to ensure full traceability of blood and blood components”.

The MHRA expectation is that traceability information will therefore be available for all blood and blood components, and retained in a retrievable form for 30 years.

However, it is accepted that occasionally, the final fate of a specific blood component cannot be confirmed. The expectation for management of these situations is as follows:

  • The monitoring for missing traceability information should be performed on a frequent and on-going basis, as the likelihood of a successful investigation gathering information to confirm final fate reduces as time progresses.
  • Steps should be taken by the blood establishment or hospital blood bank to investigate each traceability failure. This should include a review of patient notes and other relevant records, with the aim of gathering information to confirm final fate.
  • Failure to confirm final fate after investigation should result in a deviation / non-conformance report within the BE or HBB quality system.

Key Performance Indicators should be routinely analysed to identify unfavourable trends that may require preventive action (Directive 2005/62/EC/Annex 9.4.2). Information on traceability failure (including any initial delay or failure to return the expected traceability information to the BE or HBB) should be trended on an on-going basis to determine whether the system as designed and operated remains under an acceptable state of control.

  • The suitability of the KPIs reviewed should be reviewed periodically as part of management review. Trending of traceability performance on ‘percentage compliance’ alone may not be sufficiently robust, particularly at high blood usage sites, where a 1% traceability failure rate may correspond to several hundred individual blood components per month. Consideration should also be given to the numbers of units which remain unfated following investigation.

For the purposes of compliance with the regulations, only the final fate of each component need be recorded and retained. Where traceability information has been confirmed following further investigation, this may be recorded as a compliant traceability record.