The world of a clinical testing lab is one of high pressure. The pressure comes from clinicians who want their results as quickly as possible. It comes from directors and managers who demand efficiency. And most of all, it comes from a constant stream of samples that never lets up.
In this era of largely automated instrumentation (operating almost always at full capacity), few things are more frustrating to lab personnel than errors that result in downtime, troubleshooting, and the need to rerun tests. Reportable results is the most important metric in a clinical lab. Any result that is not reportable translates into higher costs, more downtime, and a growing backlog.
What can you do to reduce momentum-killing test failures and repeats while increasing your reportable result rates?
Here are three tips:
1. Detect Trends (and Prevent Failure) With External Controls
Assay failures — the failed runs that force repeats and downtime — can be caused by technician errors, software issues, and instrumentation problems. Most of these problems don’t just spring out of nowhere, nor are they immediately apparent. They develop over time.
Unfortunately, if you’re not using properly designed controls, these troublesome trends may be missed until it’s too late and an assay run fails. As if downtime, backups, and cost increases weren’t enough, testing failures also signal the possibility that erroneous results were released from the lab and used to make a clinical treatment decision. And nothing could jeopardize your lab’s reputation more than that.
While most clinical labs do faithfully run the controls provided in IVD manufacturers’ assay kits, unfortunately, these are not effective measures of true assay performance over time. Not surprisingly, in-kit controls are optimized to work with their assay and instrument platform. They are most often strong-positives, made from the same materials as the assay calibrators themselves. Thus, they tend to mask weaknesses in assay performance, and do not pick up troublesome trends readily.
To evaluate your assays properly, use third-party controls that mimic the conditions you’re more likely to find in the real world. These independently manufactured controls should be patient-like samples that challenge assays near the clinical decision cutoff.
2. Use External Controls to Train and Monitor Personnel
Not to be underestimated is the critical role training (and re-training) of lab personnel plays in any comprehensive quality control (QC) program. In a high-volume clinical lab, new technicians must learn quickly to operate efficiently and without error. They must master evolving technology and get up to speed with new assays and platforms. A simple pipetting mistake can mean the difference between a positive and negative result.
Obviously, it’s much better to catch and correct operator error before it affects testing results (and patient care decisions). With well-defined external controls, you can monitor and test staff performance without incurring any more downtime than is necessary for training. This will help ensure the entire lab is operating at the same high level of quality, efficiency, and accuracy.
3. Create a Robust Quality Control Program
Your lab’s best defense against testing errors is a robust, “top-to-bottom” quality control program.
There are several ways to enhance your lab’s QC practices. As we’ve already mentioned, highly-characterized third-party controls that challenge your assays at their limits should be the centerpiece. Other elements include: documentation of detailed standard operating procedures, training and evaluation of lab personnel, defined corrective action/preventative action protocols, and maintenance of state and federal certification through participation in proficiency testing programs.
Give your lab’s QC program a checkup with our free eBook for clinical laboratory professionals, “Best Practices for Clinical Labs: Strategies for Implementing a Best-in-Class Quality Control System.”