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