Electronic Signatures

LabDriver uses two types of electronic signatures the Esig and the Qsig.

This is a record which user made which change to a result. The Esig and QSig appear on a lab report and in the audit trial. The electronic signature is a record of which user made the most recent change to a lab result or record.

An Esig does not need to be created for all users, but must be given to users who will enter and validate lab results. Users who are not authorised to enter or validate results (such as a user who will only be producing invoices) do not need an Esig or Qsig. Users that do not have an Esig will still have their user name recorded in the Audit Trail.

The Esig is normally the initials of the user and is unique to that laboratory. For example a user called John Smith may have an Esig JAS. The Esig is different to the Username of that person. The Esig can be created for a person at any time, when their user account is setup, or later on if their job role changes. Only a user in the Superuser group can setup an account and assign an Esig.

A Qsig is given to a user with the authority to check results. A user with an Esig does not necessarily have to have a Qsig. Some laboratories prefer that one person should enter results and a different person should check them, in which case there will be two different Esigs and Qsigs on the lab report.  

The Esig of the user is recorded whenever lab results are entered or validated. Laboratory results can be entered manually or imported via an analyser interface. The Esig of that user is recorded against the profile of the results they have validated.

This means that the person who changed a result has taken responsibility for all the results in that profile. If a result is changed the Esig is changed to that of the the person who changed the result, even if only one result in a profile of 30 tests is changed.

If a result is outside of the reference range it must be validated. When a result is validated the Esig for that profile is updated to that of the current user, irrespective of whoever first entered or imported the results.

An extract for the audit history is shown below. The Esig and Qsig appear in the sample and profile changes log. The extract show a sample booked in on 5 Jan and completed the same day with a Qsig. The sample time was found to be incorrect and it was then changed on the 31 Jan. The sample status changes from Complete to Active and the Qsig is now blank. When the sample time has been entered again and the sample checked a new Qsig appears and the sample is marked as complete.


Sample Changes Log:
Name                    Date             Log time type:    from                       to
Steve Bridge        05/01/2007  11:36:06      SStatus      Active
Sophie King         05/01/2007  11:53:48      SStatus      Active                     Complete
Manual entry
Steve Bridge        05/01/2007  11:56:46      QC-Esig                                 SLB
Steve Bridge        05/01/2007  11:56:46      SStatus      Complete                   Checked
Sharon Ridge        31/01/2007  12:49:50      QC-Esig      SLB
Sharon Ridge        31/01/2007  12:49:50      Sample2      05/01/07@14:00     
Manual entry
Sharon Ridge        31/01/2007  12:49:50      SStatus      Checked                    Complete
Manual entry
Sharon Ridge        31/01/2007  12:49:50      Lab rec.     05/01/2007                
Manual entry
Sharon Ridge        31/01/2007  15:27:13      QC-Esig      SLB                        SLR
Sharon Ridge        31/01/2007  15:27:13      SStatus      Complete                   Checked
Profile                                                ESig comment
CHEMISTRY             Serum                            Commented PB
COAGULATION           Plasma                           Commented SK
DRUGS OF ABUSE        Urine                            Commented PB
ENDOCRINOLOGY         Serum                            Commented SLR
HAEMATOLOGY           Whole Blood                      Commented SK
HIV                   Serum                            Commented PB
MICROSCOPY            Urine                            Commented SLR
URINALYSIS            Urine                            Commented SK
URINE HORMONES        Urine                            Commented SLR
VIROLOGY              Serum                            Commented SK