by Nabil Hafez | Oct 3, 2017 | Blog
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.
About the author
Sr. Director Product Management and Marketing, Sunquest Mitogen
After cutting his teeth on the Human Genome Project, Nabil was hooked on genetics. Sixteen years later, his passion remains focused on enabling technologies to bring precision medicine to mainstream medicine.