DCM4MD:Project Use Cases

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• Reference to Actors
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:: 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.

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 number or receive patient demographics from hospital information systems.

Actors

• Medical Device
• Device Manager
• Operator
• EHR-System

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 untils its location is recorded in an information system.

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 informaiton 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.

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

Actors

• Medical Device
• Device Manager
• Operator

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.

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.

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

Actors

• Medical Device
• Device Manager
• Operator

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 appopriate patient record and associates the device with the patient.
• When the patient 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) before it is permanently committed to the patient's record.

Associate the Medical Device with a Patient by Patient Identifier

Actors

• Medical Device
• Device Manager
• Operator
• EHR-System

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 acurate the association between the patient and device and its output data will be.

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 identifyable patient information needs to be sent by the device