"Device, Applied"
Data elements that meet criteria using this datatype should document that the device indicated by the QDM category and its corresponding value set is in use, or impacts or alters the treatment, care plan, or encounter (e.g., an antithrombotic device has been placed on the patient's legs to prevent thromboembolism or a cardiac pacemaker is in place).
Timing:
- relevantPeriod addresses:
- startTime - when the device is inserted or first used.
- stopTime - when the device is removed or last used.
- relevantPeriod references a start and stop time for a device if the application occurred over a time interval.
- relevant dateTime addresses the time the device is applied if it was used at a single point in time.
- author dateTime references the time the action was recorded.
- Refer to the eCQM expression to determine allowable timings to meet measure criteria.
Note: negation rationale indicates a one-time documentation of a reason an activity is not performed. Negation of QDM datatype-related actions for a reason always use the author dateTime attribute to reference timing and must not use relevantPeriod.
See Appendix 6.1 for updated guidance regarding how to use Device, Applied
Device
Device represents an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including a component part or accessory, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and not dependent on being metabolized to achieve any of its primary intended purposes.
Documented evidence of a device may exist in a clinical record in various ways:
- A provider may document placement of a device as an intervention or procedure (e.g., the QDM datatypes Intervention, Performed, or Procedure, Performed). Example: Procedure, Performed: Pacemaker insertion.
- The provider may document presence of the device as a finding, perhaps including the finding on the problem list. Example: Diagnosis: Pacemaker present, or Assessment, Performed: Pacemaker present.
- A provider may also document the device in a specific device use statement or assessment.
- Example: Device, Applied: Transtelephonic monitoring of pacemaker assessment. Note that the current use of the QDM datatype 'Device, Applied' usually references the procedure to 'apply' the device (i.e., to use for the patient, to use on the patient's body, or to implant in the patient's body). Each of these current uses should address the concept using the QDM datatypes, Intervention, Performed, or Procedure, Performed.
anatomicalLocationSite
- Where the diagnosis/problem manifests itself (a).
- That is the focus of the action represented by the datatype (b).
authorDateTime
The time the data element was entered into the clinical software. Note, some datatypes include both relevant dateTime and author dateTime attributes. When both are present, author dateTime is included to accommodate negation rationale.
The author dateTime addresses when an activity is documented. Documentation can occur at the beginning, during, at the end, or subsequent to the end of the activity. The author dateTime should be used only if the relevantPeriod cannot be obtained or to represent the time negation rationale is documented.
Note: negation rationale indicates a one-time documentation of a reason an activity is not performed. Negation of QDM datatype related actions for a reason always use the author dateTime attribute to reference timing and must not use relevantPeriod.
negationRationale
Indicates the reason that an action was not performed. Only QDM datatypes that represent actions (e.g., performed, recommended, communication, order, dispensed) allow the negation rationale attribute. The intent is to indicate a justification that such action did not happen as expected. This attribute specifically does not address the presence or absence of information in a clinical record (e.g., documented absence of allergies versus lack of documentation about allergies). QDM assumes a world view that absence of evidence indicates information does not exist or an action did not happen. To express such lack of evidence, an eCQM author should use the CQL expression not exists with reference to the data element rather than the QDM data model. negation rationale in QDM signifies only a reason for such absence, i.e., the reason must be present to qualify for negation rationale. The syntax in the human readable HQMF is addressed in CQL examples and in the MAT User Guide. Prior versions of QDM used the syntax, "Procedure, Performed not done." QDM versions starting with 5.3 use the syntax, "Procedure, not Performed." Section A-5 provides examples for expressing negation rationale in CQL.
Note: negation rationale indicates a one-time documentation of a reason an activity is not performed. Negation of QDM datatype-related actions for a reason always use the author dateTime attribute to reference timing and must not use relevantPeriod.
performer
reason
relevantDateTime
relevantPeriod
Relevant Period addresses the time between the start of an action to the end of an action. Each datatype using relevant period defines specific definitions for the start and stop time for the action listed.
Note: negation rationale indicates a one-time documentation of a reason an activity is not performed. Negation of QDM datatyperelated actions for a reason always use the author dateTime attribute to reference timing and must not use relevantPeriod