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Figure
2. Institutional equipment report showing number and type of oxygenator used at a given institution.
a value for each pre-selected data variables. A score sheet, formatted by the PLN DCC, is used to record the findings. Discrepancies are identified and resolved in real time. These discrepancies are logged into a report. Following the audit, a wrap-up meeting occurs with the auditor and site clinical champion to review the findings. After reviewing the audit reports, the score sheet is returned to the DDC where major and minor discrepancies and overall accuracy rates are calculated. Major and minor discrepancies were voted on by members of the executive committee. Upon completion, results are sent to the clinical champion along with an audit findings report.
Subsequent audits are conducted once every 3 years. The subsequent audit format is identical to the initial audit with the only exception being audits may be held entirely remotely, unless there has been significant turnover in the site’ s perfusion team, clinical champion, or data abstractors. Once an audit report has been issued to the site, including all findings, affected records, recommendations, requirements for resolution of any discrepancies, the site’ s plan for corrective actions and any necessary data cleaning should be submitted to PLN with a timeline for completion of the corrective actions.
To ensure the highest level of data quality for all quality improvement( QI) processes, quality assurance( QA), or research requests utilizing PLN registry data, discrepant findings during a site data audit with a major discrepancy rate( MDR) in excess of 5 % and / or an overall accuracy( OA) less than 90 % will be considered an audit failure. Should a site fail an audit, the site’ s data will be quarantined from use for any QA, QI, or research project. Once the data has been cleaned and updated and any systematic issues resolved, the quarantine will be lifted. An MDR of less than 5 % or an OA of greater than 90 % is considered a successful audit, and the site’ s data may be used in QA, QI, and research projects. However, the site must correct any data errors and systematic issues identified during the audit.
No QI, QA, or research projects have been completed since the inception of data submission in October of 2021. The executive committee decided to wait on all data requests until site audits were complete and validated and a significant amount of record submissions were present in the registry.
PLN’ s reporting platform provides three main categories of data visualizations including blinded, institutional, and perfusionist comparison reports( Table 2). The blinded reports return aggregate data for each site. The sites are blinded by way of a site ID which changes each year. The site ID is a randomly generated number that changes at the first of the year, which is shown on comparison graphs and data. To facilitate learning and sharing, the clinical champion at each site has access to the blinded site key. This allows clinical champions to communicate about techniques, technologies, device use, and other topics. Data in blinded site reports is aggregate data only and cannot be separated out into specific case data( Figure 1).