...
A series of frequently asked questions around certain audit trails and their interpretation.
...
Item audit stamps do not indicate source of data (e.g. device vs user). For example: An audit stamp of User: “Jane Doe” with Reason: “User Entry” appears to be used for both direct data entry and externally sourced data.
...
Response
Critical to this question is an understanding that data is not automatically imported from medical devices used at the bedside. It typically requires a user to initiate a measurement (Invoke Device
) in order for the data to be imported from the configured device.
...
For this reason the audit trail appropriately lists the user name for that member of staff responsible for the procedure.
Once captured, when inspecting the Item Data
and Item Group Data
on associated with a form , it is easy to tell that will reveal that specific data was designed, and intended to be collected, using a device interface. You
For Item Data Details
there is a ‘Device Parameter' field that will indicate the item values were meant to be collected by way of a specific interface parameter.
...
When reviewing the related Item Group Data
on the form, you will see a Device Profile
listed...
...
The Device Parameter
and Device Profile
is attributed are not present when there is no intended device interface for that data.
...
Every time this occurs an unlocking Annotation
is created, capturing the ‘unlock reason’ provided by the user.
...
The When using device connected forms, the logged in user responsible for operating the equipment is recorded in the Audits
...
...
In every case, it is always possible to determine whether an item Item was collected manually or by means of a device integration.
...
As always, the logged in user responsible for triggering the Method is recorded in the Audits (3)…
...
In summary, where you see Calculated Via Method
or Calculated Entry
this denotes that the value has been determined programmatically by the system.
...
This is not strictly true and will vary from device to devicedepending on the design of the form, and the particular device that may be integrated with the form.
Vital Signs - example
In the following example we see a Vital Signs device integration being used. Due to technical limitations, the device itself does not pass the a measurement time to ClinSpark. What is For that reason, the form was designed without any specific Items intended to capture and use a datetime from the device and attribute to the collection time.
When a user Saves the form, the collection time is recorded with that action.
When inspecting the form Item Group Details, recorded is the time that the form is saved (at 1 and 2)…
...
It is therefore When relying on this kind of device and form design, it is incumbent upon users to complete the procedure smoothly and quickly and to save the form as soon as the measurement has been captured and thus best representing the measurement time. With typical workflows it is expected that this should occur within seconds of the measurement being performed.
...
In another example we see a device integration where the device captures the a measurement time and is capable of transferring this to ClinSpark. The Collected This device measurement time can be used as the form collection time.
The design of the ECG form contains a particular Item called EGDTC
intended to be used as the time the measurement occurred. This item will represent the acquisition time of the ECG, provided from the device.
...
When inspecting the ECG form after it’s been collected on, it can be confirmed that this Item datetime value was collected as part of a device parameter…
...
… and that the corresponding Item Group is using that Item datetime as the collection time of the form.
...
Additionally, collection times shown in (1) and (2) can be seen on the ’source’ ECG waveform as well by clicking View
(3)…
...
Further Reading
...