RI Mobile Overview

RI Mobile Product Description 

The Spacelabs mission is to redefine avoidable deaths by identifying patient deterioration earlier. Leveraging the Rothman Index (RI), Spacelabs assists organizations by providing an early warning system that alerts clinicians to patient deterioration that may lead to life-threatening conditions through a visual
representation of the patient’s condition. The RI is automatically calculated from nursing assessments (including Braden or Braden Q), vital sign documentation, and lab results. Today, RI Mobile, can be accessed through a web-based URL on mobile devices. 

This product guide describes the functionality of RI Mobile to assist end users in using and understanding the components of the product. RI Mobile is powered by RI Server - the platform that imports electronic health record (EHR) data to compute and store RI scores and related measures. The product provides a mobile, interactive, web- based interface that displays groups of patient's RI Mobile Graphs, RI Scores and Warning states across facilities, units, service lines, populations or providers. 

Applicability and Conditions of use

RI Mobile is a prescription-use only device that is intended to be used by healthcare professionals throughout the hospital setting as an adjunct to clinical decision making. RI Mobile may be used with neonatal, pediatric, and adult patients. For the pediatric population certain inputs are age-adjusted, and the resulting RI score is referred to as a pediatric Rothman Index (pRI). 

RI Mobile can be a valuable adjunct to clinical decision making. However, RI Mobile is not diagnostic, is not a replacement for vital sign monitoring, adn is not intended to replace patient monitoring systems. 

The absence of an RI score, or the absence of a RI Mobile warning state, should not be constructed to indicate that the patient's health is good, improving, stable, not declining or crashing, or otherwise not in need of immediate attention or that treatment is safe, appropriate m beneficial, or effective. The normal standard of care appropriate to any patient should always be maintained. 

The information conveyed to the user by RI mobile is not intended to replace normal standard of care delivery. 

CAUTION: Federal law restricts this device to sale by or on the order of a physician. 

RI as a General Score of Condition

As a general score of patient condition, the RI does not consider disease-specific measures (e.g., cardiac enzyme, blood glucose, or lactate levels) or medications or support systems (e.g., supplemental oxygen, mechanical ventilation). Hence the RI indicates how the patient is doing considering current treatment, not what the patient’s condition might be if they were not receiving treatment. Care decisions
may be informed by knowledge of the patient’s RI score but should also be determined based on professional clinical judgement that incorporates broader knowledge of the patient, including the patient’s history, diagnoses, plan of care, etc. 

Indications for Use

The Rothman Index uses commonly recorded vital sign, nursing assessment, and lab data to provide a patient status index. The Rothman Index is a single measure of a patient's physiological condition based on the aggregate statistical mortality risk associated with the values of the patient's vital signs, nursing assessments, and selected lab values. 

RI Mobile is indicated for use by healthcare providers within the hospital for displaying and/or trending Rothman INdex (RI) scores and displaying associated configurable warning states as an adjunct to clinical decision support. 

RI Mobile is intended for use in the hospital fto support the Rapid Response Team clinicians or other dedicated clinical response staff responsible for proactively rounding on patients of concern and/or providing supplemental support to bed-side clinicians.  

Expectations for use

expectations for the use of RI Mobile, including workflow integration and protocols for use, are determined by each customer organization in accordance with their respective clinical aims and policies, as well as clinical teams in place within the organization such as a dedicated rapid response team. 

The Rothman Index score is validated for use with neonatal, pediatric, and adult patients. It is an adjunct to and is not intended to replace vital signs monitoring and is not intended for use in the Neonatal Intensive Care Unit.

Reliance on Documentation 

RI Mobile data is based in data received from the EHR and ancillary (e.g., lab registration and ADT) systems. Inaccurate or delayed clinical documentation may lead to inaccurate or delayed RI scores. 

Timely documentation is required to obtain the most up-to-date RI Server information related to a patient's condition. 

CAUTION: RI Scores displayed in a RI Mobile graph may not reflect the current condition of the patient. 

The lag time that may exist between the time when clinical measurements are obtained and the time when they are entered into the EHR is a fundamental challenge in assessing patients via EHR data.

CAUTION: As new data is received by the RI Server system, RI scores at previous times may be updated on the RI Mobile graph. 

A clinician who wishes to see the RI score of a patient in the current moment must ensure that current clinical data is collected and entered into the EHR to generate an RI score reflective of the patient's condition at the same moment. Delays in entering data into the EHR will result in RI Mobile graphs that are not current; and users must be aware of the risk that RI scores displayed in a RI Mobiel graph may not reflect the most up-to-date condition of the patient. 

CAUTION: RI Scores can only be computed when the requisite data is available. For some patients, particularly obstetric and psychiatric patients, the minimum data elements (including nursing assessments) needed for an RI score may not be routinely collected, and therefore RI scores for these patients may not be available. Provided that the minimum required data elements are recorded and entered into the EHR, RI scores will be calculated for these patients. 

Customers must inform Spacelabs about changes to clinical data fields or system documentation that pertain to any of the fields used as inputs to the Rothman Index. 

Reliance on Data Connectivity 

RI Mobile data relies on active and functioning data feeds from the EHR and ancillary systems. If data interfaces are paused or disrupted, or there is EHR system downtime, this may result in gaps or delays in RI Mobile graphs. Users should be aware that scheduled EHR downtimes and/or unplanned EHR outages will both impact availability and timeliness of RI Mobile data. 

Training and Education 

Before using RI Mobile, users should be sure they have received organizational training and instruction regarding the appropriate and expected use of the application. Customer organizations are responsible for ensuring appropriate use of the product.

Organizations will develop their own protocols for use and determine how end-users should integrate RI Mobile into their workflow. When in doubt, users should seek guidance from appropriate members of their organization’s staff. Most customer organizations contract to utilize Spacelabs clinical implementation services. Spacelabs can provide guidance on implementation strategies, as well as
deployment support that can include on-site or remote training by Spacelabs staff together with supporting information and training material.