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

Merging Patient Records

Clarification November 2007

The Serious Hazards of Transfusion (SHOT) annual reports highlight the clinical problems that can arise with duplicate (or multiple) patient records. Transfusion laboratories endeavour to ensure that only one patient record is in existence. Latterly, amalgamation of hospitals/Trusts has increased the instances where more than one hospital number is available for patients.

The MHRA has raised concern about the possibility for traceability records to become lost when merges are undertaken in the Laboratory Information System (LIS), especially if the LIS is the primary method of maintaining the traceability record for 30 years (Blood Safety and Quality Regulations 2005).

On merging, it is imperative that the historical data and the results ascribed to them must not change.

To ensure that the process for merging is clear, hospital transfusion laboratories (HTL) should have the following in place: -

  • Only nominated staff with appropriate password privileges can use the merge function.
  • Clear, precise documentation on when a merge can be undertaken (SOP), including the safety criteria and checks applied to ensure that the merge is correct. This should address the retention of all historical group and screen information, special requirements (e.g. irradiation) and any specific antibody investigation information plus the identity of the person undertaking the merge.
  • Training procedures (and records) relating to the SOP.
  • Ensure that documentation is maintained to (i) ensure that Traceability requirements as listed in the Blood Safety and Quality Regulations 2005 are met, and (ii) provide an audit trail of the individual records merged to form the single record.

If merging of patients is undertaken by members of staff outside the transfusion laboratory, the following must be followed: -

  • Understanding of the affect of patient merges on the LIS
  • Clear, precise documentation on when a merge can be undertaken
  • Where transfusion records are present it should be specified that the merge can only be undertaken following written authority from the HTL in advance of the merge taking place.
  • Documentation sent to the laboratory on what and who has been "merged"
  • Ensure that traceability records are maintained

The likelihood of Traceability being lost is even higher if patient merges require unmerging. Consideration should be given to whether paper or suitably archived electronic records may need to be maintained to ensure that Traceability and other information critical to patient safety is protected. These may need to be kept for 30 years if used for Traceability purposes. These archived records should ensure that merged patient data can be correctly split into their original component parts, in case it becomes apparent that an error was made in the merging process.

The MHRA would support the process of merging duplicate records provided that this is performed in a controlled, robust manner, to ensure that risks to patient health through incomplete patient records are minimised (i.e. multiple concurrent records which may all hold different safety information).