DCM4MD:Project Use Cases

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DCM4MD:new document

:: May 2011 Use Cases ::

The following use cases have been identified to be in scope for the May 2011 ballot of the DCM for Medical Devices Project. The focus of this ballot will constitute DCMs that are required to support

  1. patient-to-device association in order to assign the data produced by the device to appropriate patient for charting and,
  2. time consistency across information systems and devices.
  3. operator-to-device association in order to assign the data produced by the device to the attending caregiver for charting

These use cases need to address the situation when there multiple patient identifiers with the same or different assigning authority

Intubation Business Use Cases

The following use workflow descriptions have been revised based on the Septebmer 2010 Ballot Comments

Rationale for the use of clinical workflows

The following paragraph contains proposed rationale for the use case analysis and clinical workflows: Rationale: The workflows described in this section are intended to illustrate the typical workflows to describe how medical devices are used to support the needs of clinicians. These clinical workflow descriptions are not intended to provide clinicians guidance on how to practice medicine but rather to describe to other stakeholders (e.g. IT, vendors, integrators, clinical engineering). The Business Use Cases in Section 1 and the Clinical Workflows in Section 2 of the DCM for Medical Devices document are intended to determine the conventions of clinical practices and to make sure that the rest of the analysis including information and system interactions.

Intubate Patient - Unplanned - Worfklow

2.1 Intubate Patient (Unplanned).jpg]

Manage Patient on Ventilator Workflow

2.2 Manage Patient on Ventilator.jpg

Liberate Patient from Ventilator

2.3 Extubate Patient, Planned (includes ventilator weaning).jpg

Associate the Medical Device with a Patient by Location

This use case is currently implemented by most legacy devices in critical and acute care environments. These legacy devices do not have the ability to record the patient's medical record number or receive patient demographics from hospital information systems.

Actors

Pre-Conditions

  • The patient is associated with a specific bed/location and the location is tracked by a hospital system. This use case applies only to specific inpatient and ambulatory settings.
  • The device is associated with a specific bed/location and it is not moved from that location until its location is recorded in an information system.
  • The device is not capable of acquiring an accurate date/time from a reference server. TheDevice Manager provides the time/stamp and, optionally, the location if it's not reported by device itself.

Main Scenario

The patient is placed at a specific location/bed and the medical devices are used to monitor specific physiological parameters or deliver specific therapies. The information produced by the device reports the location where the device was placed.

Alternate Scenario

Instead of the device, the Device Manager or concentrator is associated with the patient location. The information system or EHR-System- uses the information reported by the device or the configure configuration reported by the device manager along with the known location of the patient to infer whose data/results/therapy needs to be recorded.

Post-Conditions

The information/data produced by the device is added to the patient's medical record based on the device to location to patient assignments perfore the Device Manager and EHR-system respectively. In some cases, the data may need to be validated by a clinician (e.g. nurse) before it is permanently committed to the patient's record.

Dependency

Synchronize Time is used to synchronize the device clock to ensure that the results are reported accurately.

Associate the Medical Device with a Patient by Identifier and Point-of-Care

Both location and patient's identifier are used to determine whether the device should be associated with a specific location.

This use case may represent a transitional state of interoperability.

Actors

Pre-Conditions

  • The device is able to record the patient's identity

Main Scenario

  • The operator scans or enters the patient's identity into the device using its user interface, bar code reader, etc.
  • The device is used to treat or monitor the patient's condition.
  • Once the device is not longer needed, the operator discontinues the association. This removes the patient's identity from the data produced by the device.

Post-Conditions

When the device is no longer acquiring data for the patient, the association with the medical device is broken. In some cases, the data may need to be validated by a clinician (e.g. nurse) before it is permanently committed to the patient's record.

Dependency

Synchronize Time is used to synchronize the device clock to ensure that the results are reported accurately.

Associate the Medical Device with a Patient by Selecting Patient on Device

This use case is applicable in highly integrated environments. It requires an encounter management system (ADT) integrated either with the Medical Device directly or through its Device Manager or an Order Entry System.

The identity may be established indirectly through an order number (e.g accession number, placer order number) that is used by the device to reference its measurmenent.  
The association may need to confirmed by end-users.

Actors

Pre-Conditions

  • The device or its device manager is tracking encounter events (e.g admission) or queries its Device Manager for patients as needed.

Main Scenario

  • The operator enter a set of patient identifier traits into the medical device to loop up the patient's identity.
  • The operator selects the appropriate patient record and associates the device with the patient.
  • When the device is disconnected from the patient, the association is automatically broken.

Post-Conditions

The information reported by the device while the device was associated with the patient is charted to the patient's record. In some cases, the data may need to be validated by a clinician (e.g. nurse, respiratory therapist) before it is permanently committed to the patient's record.

Dependency

Synchronize Time is used to synchronize the device clock to ensure that the results are reported accurately.

Associate the Medical Device with a Patient by Patient Identifier Only

This use cases provides the most efficient patient-to-device association provided that the patient's identifier is entered correctly into the device.

Actors

Pre-Conditions

  • The device is able to record the patient's identity.

Main Scenario

The Operator enter the patient's identity using the device input device (e.g. keyboard, bar code scanner). The precision with which the patient's identifier is entered into the device determines how accurate the association between the patient and device is, and consequently, how accurate the patient identity component of the output data is.

Post-Conditions

The information is received by the destination information system or EHR-System and associated with the patient identified by the their patient identifier. In some cases, the data may need to be validated by a clinician (e.g. nurse) before it is permanently committed to the patient's record.

Security Risk Assessment

  • The date in transit may not require encryption since no identifiable patient information needs to be sent by the device

Dependency

Synchronize Time is used to synchronize the device clock to ensure that the results are reported accurately.

Synchronize Device Time Across the LAN

Actors

Pre-Conditions

Main Scenario

The medical device connects to the Network Time Server to set up its clock to accurate date/time. The device clock is used to timestamp the results or parameters reported by the device to the EHR-System.

Post-Conditions

The device is synchronized with the Network Time Server and implicitly with any other information systems or devices.

Synchronize information from patient transport

High priority for clinicians to discuss this use case.
  • This use case includes moving the patient between care units in the patient.
  • The patient stays associated with the device regardless of the location of the patient.
  • There are no interruptions in the flow of information - even though the device may not be connected at all times to the EHRS.
  • The measurements are reported to the EHRS regardless of the patient location.

Actors

Pre-Conditions

Main Scenario

Post-Conditions

Associate the measurement with a clinician

In addition to the device-patient association, the providers organizations would like to record in the EHRS the clinician's id. Ideally this identifier would be scanned into the device.

  • The identifier may be entered at the point-of-care
  • The identifier is authenticated with the device or device manager

EHR-System.