Title

Start reviewing and authorizing results (i.e. validation of results) before releasing the report

Why

Transcription of information is an activity that is prone to errors. Therefore, to assure that results and other important information (such as patient information) on reports are transcribed correctly from the Request Form, work forms and the register, and that the reports are complete, a second staff member, additional to the staff member drafting the Result Reports, must verify that the correct values and information have been transcribed.

What

Establish a procedure for reviewing results and important information and authorizing each Result Report for release. The person authorized to perform this procedure must be somebody in a management position (either the head of the data management section, the head of the section where the testing was performed or the laboratory manager him/herself).


In this procedure a review is done to verify that all the data and results in the Result Report have correctly been transcribed from the Request Form, the work forms and the register. It must also be verified that results are legible and that quality controls were correctly performed on the day the results were produced (to determine if the examinations were performed correctly and that reagents and equipment were performing correctly). In addition, it must be verified that the report is complete and contains all the information necessary. Once it has been determined that everything was done correctly and all the information is complete and correct, the authorizer may sign the report and thereby authorize the report for release.


You can make use of a checklist to ensure that every review and authorization of Result Reports is done completely. An example of such a checklist is provided in the right-hand column.


Later in phase 2 the SOP for Recording, Reporting and Archiving of Results will be developed. This SOP will include the protocol for this procedure.

How & who

Laboratory Manager:

  1. Adapt the Authorization Matrix to include the responsibilities and tasks of reviewing results and report authorization.
  2. Determine who will be authorized to review results and authorize the reports for release (this can also be you). Also determine who can replace this staff member in case of absence, to ensure that there is always somebody present for reviewing results and authorizing reports for release.
  3. Explain the assigned staff member and the back-up staff member the tasks and responsibilities and why this procedure needs to be performed on every Result Report.
  4. Adapt the Personal Job Description of the staff members to include the new set of tasks and responsibilities belonging to this procedure.
  5. Assist the staff members the first few days in performing this procedure to assure that it is performed correctly and runs smoothly.

Back to Roadmap Activity Overview
This activity belongs to the QSE Information Management
ISO15189:2007: 5.7.1
ISO15189:2012: 5.8.1
ISO15190:2003: