Introduction
A series of frequently asked questions around certain audit trails and their interpretation.
How do I know if data was collected using a device?
Observation
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, inspecting the Item Data and Item Group Data associated with a form will reveal that specific data was designed, and intended to be collected, using a device interface.
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 attributed are not present when there is no intended device interface for that data.
Under certain circumstances, the operator may need to over-ride the device integration and submit data manually…
Every time this occurs an unlocking Annotation is created, capturing the ‘unlock reason’ provided by the user.
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 was collected manually or by means of a device integration.
How do I know if data is a calculated or derived rather than entered by hand?
Observation
Non-user entries (e.g., Calculations, device, and imported data) appear to be stamped as user instead of systems
Response
With newer releases of ClinSpark calculations such as Methods are clearly flagged as such.
In this case the response to the question Are Vital Signs Out of Range? has been derived by a Method and determined to be No.
This is clearly shown here at item 1.
In addition, an Annotation (2) shows that the Item is a Calculated Entry.
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.
What time is shown on a form when data is collected using a device?
Observation
For device uploaded data, the collection date/time shown in ClinSpark represents when the user performed the upload rather than the actual collection
Response
This is not strictly true and will vary depending 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 a measurement time to ClinSpark. 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)…
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.
ECG - example
In another example we see a device integration where the device captures a measurement time and is capable of transferring this to ClinSpark. 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
You may find the following articles useful…