Quality Assurance

Quality Assurance

Quality Assurance

All operations of the Cardiovascular Core Lab at Morristown Medical Center are done in accordance with general lab-wide Standard Operating Procedures (SOPs), study-specific SOPs, and Good Clinical Practice (GCP) guidelines. To ensure high-quality services, our lab has in place programs to provide first-class education, communication and echocardiographic analysis.

Quality Assurance of Echocardiographic Information

All clinical sites, participating cardiologists and sonographers are provided with educational material and ongoing constructive feedback to help ensure excellent echo image acquisition.

Quality Assurance of Echocardiographic Analysis

All Cardiovascular Core Lab staff members are trained in overall lab operations as well as study-specific procedures and echocardiographic analysis.

Interobserver and Intraobserver Variability is evaluated and tracked for each study and for each Cardiovascular Core Lab reader. This information is documented and available for sponsor review. All studies are reviewed independently by an experienced sonographer and two specially-trained cardiologists/echocardiographers.

Quality Assurance