(back to Outcome Analysis and Safety Surveillance)

Case Study — Cardiac Cath Lab Safety and Outcome Analysis

A nationally-recognized cardiac catheterization laboratory, under the direction of the cath lab manager, became interested in developing a system that would provide surveillance and predictive capabilities to identify low-frequency systemic adverse events and trends. The goal was to ensure that the cath lab was providing the best care possible for patients and to act as a model that others might follow for safety surveillance.

Business Driver

There were a number of drivers behind this project, including:

Insuring safe care of critically ill patients.
Monitoring the safety of new treatments.
Preparing safety reports for regulatory reviewers.
Conducting academic research in medical safety and statistical methods.

Solution Description

Working under the direction of the cath lab manager and funded under a NIH grant, Coping Systems partnered with the cath lab to develop a comprehensive safety surveillance and support system called DELTA. The system was designed to run continuously using statistics to analyze key clinical data points while automatically identifying adverse events and negative trends.

The system uses several statistical methods designed to provide a wide coverage of both specificity and sensitivity. If a negative event occurs, the system generates an alarm which is available via a web portal or can be emailed to study subscribers monitoring that condition.

Benefit

DELTA provides several benefits to the cath lab. Output from the system is shared with the entire staff via a web-accessible report card so comparisons can be made of their individual performance to benchmarks established by state and federal regulators. The system has also led to advances in treatment designed to reduce the potential of bleeding caused by intravenous catheter insertion.

Project Deloyment

Coping Systems worked closely with the cath lab to develop and implement DELTA. Before the system could be implemented, automatic data feeds from the cath lab hemodynamic system and from other clinical systems were developed. Efforts were made to ensure that data was captured close to the point of care to insure accuracy. More than 200 variables are gathered from each patient so that an almost unlimited number of analytical experiments can be set up to run simultaneously.

The next step in the project (currently underway) is to distribute the system among a number of peer institutions and to the State level health regulatory agency. The goal of this network is to gather more data faster so that trends can be spotted more quickly and shared more effectively.

System Configuration

Key Components
Products	DELTA CASCADE
Services	System Analysis and Design Intellectual Property Development Project Management Clinical Level Test Clinic Deployment Continuous Remote Monitoring of System Health
Infrastructure	Microsoft SQL Server Microsoft Internet Information Server
Summary	The cath lab worked with Coping Systems to develop an industry leading safety analytics and surveillance system. The system is operational and continuously monitors the safety of the clinic. The system is being enhanced to enable a network of hospitals and state regulators to monitor key safety related trends.