Why Data Provenance is Crucial for Clinical Diagnostic Labs

What is Data Provenance?

Data provenance, also known as data lineage, refers to tracking the origin of data and continuous changes in data with time. Data provenance helps in tracking errors within data and finding sources of such errors. Furthermore, maintaining data provenance is essential for clinical laboratories if they are preparing for audits. Data provenance in a clinical diagnostic laboratory should commence from the time a sample enters the laboratory until the test results are reported.

Importance of Data Provenance

Clinical diagnostic laboratories generate and store massive amounts of data daily. Many laboratories still use traditional documentation methods to manage and record data. They still practice taking instrument readings manually and maintaining handwritten notes. These notes are then transcribed into excel sheets, thus leading to transcription errors. Moreover, manual procedures of data management reduce data interoperability, leading to data silos. Laboratory professionals also practice double data entry to catch and minimize errors but end up losing significant time and effort. Digital transformation is essential for laboratories to overcome these challenges and reinforce data provenance.

The digitization of processes and data management techniques is paramount for tracking provenance and eliminating data silos. Modern laboratories ensure that all steps of diagnostic processes are documented digitally so that they can track and manage all data using a single system. This helps them streamline workflows, meet compliance standards, and strengthen data provenance. Data provenance provides a cohesive understanding of the role of all staff members in a laboratory. When data is recorded electronically, it becomes easy to track its origin, share data and test results with colleagues, reducing the turnaround time. Furthermore, any changes in data can be easily updated and recorded for future use if maintained digitally.

Why Should Clinical Diagnostic Laboratories Prioritize Data Provenance?

Clinical diagnostic laboratories must securely manage sensitive patient data and laboratory records. This helps laboratories meet regulatory requirements, such as CLIA, HIPAA, ISO 15189. Data provenance also aids in interpreting data and tracing back the test results to samples and associated patients. Data provenance supports the reproducibility of laboratory findings by providing all the necessary data and associated metadata as and when required. The efficiency of laboratory processes and performance of laboratory staff can also be examined, providing an area for improvement in case of any deviations from set standards.

How Does a Clinical LIMS System Support Data Provenance?

A Laboratory Information Management System (LIMS) can help clinical diagnostic laboratories maintain data provenance in the following ways:

1. Assign role-based patient data access to authorized personnel only to safeguard Protected Health Information (PHI) of patients.
2. Track all laboratory activities along with a date and time stamp by maintaining a read-only audit trail.
3. Manage documents, such as procedure manuals, instrument maintenance manuals, and ensure document control.
4. Manage all patient data, including demographic details, patient consent, and patients' medical history.
5. Store annotated sample data and track samples using barcodes and print labels.
6. Manage all aspects of sample genealogy. It also helps maintain a sample chain of custody (CoC) and access a complete history of each sample from accessioning to the final disposal.
7. Support instrument integration for the effective management of growing data volumes. Instrument integration also helps eliminate chances of transcription errors, data redundancy and also assures data integrity.
8. Ensure automated workflow management and track deviations from standard workflows.

Conclusion

Data provenance helps laboratories record the origin of data throughout the sample lifecycle. It helps laboratories understand the relevancy of data. Data provenance puts an end to functional laboratory silos and helps track and manage data in all steps of laboratory processes. Clinical diagnostic laboratories should create a foundation for strong provenance and ensure complete data traceability.

Data provenance helps modern laboratories streamline workflows and comply with regulations. Diagnostic laboratories must implement a secure and reliable data management system for collecting, storing, processing, analyzing, and reporting all data. A clinical LIMS system streamlines existing processes and facilitates data recovery even after years of diagnosis.