Hazard Statements

CAUTION: Ensure that the risk scoring, risk stratification, and risk-based notification rules configured in the Rules Manager are properly defined in accordance with hospital guidelines prior to system deployment. This includes defining the risk factor (risk score components) stale times, displayed risk context, and recommended clinical tasks per Facility policy. If adjustments need to be made, contact the assigned Hillrom Clinical Specialist or Hillrom Technical Services at (800) 445-3730.

CAUTION: Ensure that the configured risk stratification rules are assigned to the proper child entities (e.g., Facilities, Units) prior to system deployment. Configured rules must be explicitly assigned in order to be active at child entity levels. If adjustments need to be made, contact the assigned Hillrom Clinical Specialist or Hillrom Technical Services at (800) 445-3730.

CAUTION: Ensure that the configured risk stratification rules are enabled, paused, or disabled, as desired, prior to system deployment. Rule status can be viewed on the Rule Inventory section of the Rules Manager. It is especially important to ensure that only a single rule is configured and enabled for a given risk score to avoid any conflicts or unexpected system behavior. If adjustments need to be made, contact the assigned Hillrom Clinical Specialist or Hillrom Technical Services at (800) 445-3730.

CAUTION: Ensure with hospital administration that the PRS system and all integrated components have been certified by Hillrom prior to room occupation by patients.

CAUTION: The PRS system must be recertified and validated after configuration changes.

CAUTION: In the event of outages, other connectivity disruptions, or system failure, follow your hospital's manual processes to complete all patient and caregiver workflows. For example:

• In the event of a system failure to process risk-based notifications, a patient's condition should be assessed based on vital signs and EMR data.
• System deployment will be certified prior to clinical use and after any configuration changes.
• System software updates are validated by Hillrom at the system level prior to clinical deployment. Software updates should not disrupt clinical operation of the system, as single clustered servers can be taken offline for software updates without affecting online servers.
• In the event of a system failure, the system can be rolled back to a prior software release to maintain operations while troubleshooting occurs.

CAUTION: Hospital network connectivity is necessary for risk-based notifications to be sent to alert managers and caregiver Voalte mobile devices. An indication of loss of network connectivity on Hillrom vitals monitors and caregivers' Voalte mobile devices mitigates the risk of a hospital network outage and is consistent with industry standards. Standard hospital procedures should be followed to prevent possible delays in treatment. A patient must be manually checked and vitals signs monitor data confirmed by a caregiver at the patient's bedside before treatment decisions are made.

CAUTION: The hospital should perform periodic testing of the PRS system to ensure the system is working properly, including after any PRS system upgrades or component device upgrades, connections, disconnections, or resets. The system must be recertified and validated after configuration changes. For more information, contact Hillrom Technical Services at (800) 445-3730.

CAUTION: Hillrom recommends that multiple levels of escalation should be in place for risk-based notifications.

CAUTION: Clinical decision support systems such as PRS are not meant to take the place of provider or caregiver interactions and knowledge or judgement. This system is meant to augment their clinical knowledge and assist in more timely and patient-specific care. Caregivers should not view this system as a replacement for their current clinical practice.