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No-fear audit trails for hospital molecular diagnostics labs

Hospitals and healthcare centers developing molecular diagnostic lab capabilities may be tempted to start with spreadsheets or paper-based systems. Find out why that approach won’t scale in this blog post.

One of the biggest differences between typical clinical lab processes and molecular lab processes is the complexity. In a molecular diagnostics lab, there are a lot more elements to track over a longer period of time, and processes are more prone to change as the discipline continues to evolve.

Some molecular diagnostics labs use spreadsheets and notebooks to document these processes, especially if their current laboratory information management system (LIMS) isn’t flexible enough to adjust to the needs of the molecular lab. But even with the most assiduous lab technicians keeping records, this method is eventually going to run into multiple problems:

1. Manual documentation is not going to scale well when a molecular diagnostics lab decides to increase its volume.

Whether they’re adding more test types or adding more patients, molecular diagnostics labs can expect demand to rise. As volume rises, keeping turnaround time down will be vital to the success of the lab. Lab techs will need to focus on testing rather than bookkeeping to keep lab flow moving. Manual documentation also makes it harder to look into trends over time.

2. Manual documentation makes it harder to pinpoint errors and correct mistakes.

Cross-referencing the specimen, the handler, the instrument and the time in various files and documents to find the explanation or origin of an erroneous result is not just time-consuming, it’s unreliable. Given the importance of accuracy and clarity in clinical pathology, the ability to look back at every step of the process is critical for both safety and confidence.

3. Manual documentation is virtually impossible to collate quickly for audits and other reporting needs.

Information may be scattered in notebooks, instrument records or personal laptops, requiring hours of effort to combine, with an increased likelihood of transcribing errors. When it’s time for a CAP audit or CLIA certification audit, a molecular diagnostics lab needs to be prepared to say who touched a selected specimen, which instruments and reagents were used, how long it spent at each stage—truly a prodigious amount of data for a molecular process in which there could be multiple offshoots of a single specimen. Bringing all this information together from assorted sources, especially for a random sample, takes a lot of valuable—and non-revenue-producing—time away from the lab’s actual function.

In other words, sooner rather than later, a hospital-based lab bringing genetic testing or other molecular processes in-house is going to hit its limits with manual documentation—possibly with some serious, or expensive, consequences.

Save time and save the worry with automatic information capture

If every action a lab technician takes—for each batch, vial, instrument, and so on—can be recorded by software as it happens, documentation can be easily incorporated into a lab’s workflow without demanding extra time and without requiring staff to learn new steps or processes. Using a laboratory barcoding system for tracking each physical element in the process, for example, eliminates the need to type information into an informatics solution, eliminating time and human error from recordkeeping.

Of course, all that data has to be organized in a useful way—ideally, in multiple useful ways. First and foremost, lab sample tracking is different in a molecular lab. A clinical Laboratory Information System (LIS) can’t be retrofitted to model the generations and relationships between samples in molecular processes. A LIMS designed and developed specifically for molecular labs, one that can accommodate a genealogical model of specimen processing, can manage the chain of custody in intricate detail, all while lab technicians do their work as they normally have. A faultless audit trail can be prepared automatically while laboratory personnel focus on processing higher volumes and reducing turnaround time.

A considerable benefit of this method is that lab directors can access this laboratory management information in other combinations too, such as focusing on a specific user path, container path or time path to evaluate and improve lab performance. A purpose-built solution for molecular diagnostics labs can provide this overview at a glance, rather than through lengthy review of diffuse records and tables, and without logging into a separate system.

Automated information capture frees lab personnel to focus on accuracy and efficiency, while recordkeeping largely takes care of itself.

For more information on expanding lab capabilities through intelligent solutions designed for molecular processes, read our white paper, Molecular Diagnostics for Healthcare Facilities: How to Start and Scale an Efficient Testing Program.

Nabil Hafez

Sr. Director Product Management, Sunquest Mitogen

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Cutting his teeth on the Human Genome Project, Nabil was hooked. 16 years later his passion remains focused on enabling technologies to bring precision medicine to mainstream medicine.

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