Regulatory and Registry Data Submission

Case Study – Cardiac Cath Lab Regulatory Submission

Each calendar quarter, a leading Massachusetts cardiac catheterization laboratory is required to submit patient-specific case data to both the American College of Cardiology’s National Cardiovascular Data Registry (NCDR) and the Massachusetts Department of Public Health’s Massachusetts Data Analysis Center (Mass-DAC).  

Before conducting safety analysis, both the NCDR and Mass-DAC monitor and audit the data for completeness and accuracy.  Data quality reports are issued back to the hospital.  Problems with data completeness or accuracy need to be reconciled by the cath lab Data Quality Manager.

Once reconciled, the registries perform a statistical analysis of the data and publish the risk-adjusted analytic results to a public website.  The validated data and the published results are used for accreditation review, evaluative research, Medicare payment authorization, healthcare quality improvement, and consumer choice guidance.

Business Driver

The cost spent by this clinic to gather, check and submit data to state and federal registries was considerable. They were generating several thousand cases per year and simply could not keep up with the process.

While a patient is being treated, their case data often will be entered into multiple systems including the central hospital information system, the cath lab hemodynamic, imaging, and the clinical reporting systems. A number of people may record this information as well: admitting and emergency department personnel, cath lab attending physicians, fellows, technologists, nurses, and managed care specialists.

Each case generates an average of three hundred fields of data; as a result of so many inputs from myriad systems, virtually every case needs to be edited.

Errors were found to fall into three major categories: medical misinterpretation, omissions and miscoding. Data that was incomplete in any way could not be submitted to the registries or else it would be rejected. This meant that the cath lab Data Quality Manager needed to worked with the team who performed the procedure to fill in the blanks and fix any mistakes. Tracking down errors would often be difficult, as busy clinicians would find it difficult to remember specific details of patients they worked with weeks in the past.

Solution Description

To reduce labor and insure the highest level of compliance to regulators and registries, Coping Systems was engaged by this cath lab facilitate a change.

After extensive collaboration with Interventional Cardiologists, Data Managers and IT staff, Coping System developed an application using the Delta Core Server to unify data from multiple hospital systems so that it could be validated and prepared for submission.

The database is updated in real-time as case data is entered into the various transactional systems. The data validation function of the Delta ETL Engine continuously monitors the case data. A cardiac catheterization validation rule set, specified by the cath lab Manager, checks every case for accuracy and completeness.  Incomplete and inaccurate information is identified and a report is generated identifying the type and cause of the data error.  

Based on the rules established by the cath lab Manager, the validation application suggests corrective actions for fixing the data.  A workflow report is created for each person responsible for the data entry.  Once per week, the workflow automatically emails the individualized report to each person responsible for the data entry including cath lab attending physicians, fellows, technologists and nurses. 

These individuals are then responsible for reconciling the data in the originating transactional system. Once they make their changes, the data is automatically synched back to the Delta Core Server to prepare the registry submission.

Each week the lab’s Data Quality Manager and the cath lab Manager receive a workflow generated report summarizing the errors and identifying responsible individuals.  Using these reports, the team can identify problem areas and track week-to-week improvement.  The workflow-enabled reports provide an effective way of monitoring the performance of hospital staff.

Benefit

The Delta Core Server together with the validation software and error correction procedures are valuable tools for this clinic, saving the hospital several hundred hours of labor each year.  Their submissions are recognized by registry reviewers as being extremely accurate, complete and timely. Additionally, the number of data errors reported has dropped dramatically as users are now more aware that any errors they make will be flagged.

The clinic has also improved the quality of the data being submitted to the registries, so that it can be analyzed statistically using the Delta Analytical Server. This analysis helps the clinic benchmark outcomes, identify potential safety issues and improve quality of care based on statistically valid key performance indicators.

Project Deployment

Phase I focused on gathering data from multiple systems into the Delta Core Server. Phase II focused on working with the cath lab Manager to encapsulate data validation rules into the system and to establish the workflow reports to the individual clinicians responsible for entering the data.

Challenges met during this implementation included:

• Reliably integrating to multiple data feeds.
• Building a comprehensive rule set for cardiac care (under the guidance of the cath lab Manager) which is user-friendly to maintain.
• Instituting practical workflows that are easy to adapt to frequent personnel rotation.

System Configuration

Solutions

» Clinical Workflow    Automation
» Post-Treatment Surveillance
» Outcome Analysis and    Safety Survelliance
» Regulatory and Registry    Data Submission
» Clinical Trial Accounting