SeraCare is part of LGC Clinical Diagnostics - Learn More

Diagnostic Precision

A SeraCare blog focused on precision medicine and advanced clinical diagnostics

Choose your Article Focus | All | NGS | Molecular & Serology

3 Root Causes of Downtime for Clinical Genomic Testing Labs (and How to Recover Fast)

Posted by Dale Yuzuki on Apr 20, 2017 12:00:00 AM

Hand_with_tube_plain.jpgDowntime can be devastating to a clinical testing laboratory. The timely return of test results is critical for effective patient care. Any delay can hurt your lab’s reputation and prompt your customers to seek testing services elsewhere.

Unfortunately, any clinical testing laboratory using sophisticated next-generation sequencing or other genetic analysis technology will suffer downtime sooner or later.

The question is, how fast can you recover?

What Causes Downtime?

There are myriad factors that could cause your laboratory to cease operations:

  • Simple operator error - anything from a sample mix-up to a PCR contamination - can cause a downstream problem that can take days or weeks to identify and correct.
  • Poorly-performing vendor supplied reagents, kits, instruments, or software.

Operators Are Human; Mistakes Can and Do Happen

As it makes its way through your lab, a patient sample interacts with a wide range of operators, materials, and instrumentation. Mistakes can creep in at any point along this process, including:

  • Labeling and accessioning.
  • The use of particular reagents.
  • The setting of instrument parameters.
  • The informatics pipeline.

When an error does occur, it can take a long time and a lot of effort to determine root cause and take action to fix it. Without an appropriate reference standard, the problem becomes more complex, as the number of potential causes increases exponentially.

Here is an example:

An operator overlooks an issue with the DNA quality going into an assay. It could be a residual contaminant or detergent used in the DNA purification. This causes an upstream amplification reaction going into the NGS library preparation to fail. The DNA quantitates fine but the contaminant causes the PCR to not amplify.

In the above example, if you had a purified DNA reference material that goes through the library creation through variant calling, you would quickly discover the poor quality of DNA purification caused the sample failure.

If there was an issue with variant calling (such as a parameter that was inadvertently changed) a purified DNA multiplexed reference standard would also quickly identify the problem with missed or incorrect genotype calls.

Your lab, like most, may use validated assays and have quality control management processes. But with high-quality reference materials acting as a truth set for your lab, you will be able to troubleshoot problems and implement corrective action more quickly.

External Factors That Can Bring Your Lab to a Screeching Halt

From sample receipt to finished report, an NGS laboratory uses a wide variety of vendor-supplied reagents and supplies. Plasticware, pipette tips, and even water quality have been known to have adverse effects on enzymatic reactions. A poor-performing lot of vendor-supplied reagents can, on occasion, wreak havoc.

Get Your Lab Back Online Quickly With Quality Reference Materials

With the root causes of downtime lurking everywhere, today’s high-complexity NGS-based testing requires high-quality and expertly-designed reference materials to provide a truth set and bring your laboratory back online quickly. SeraCare has a 30-year history of supplying the diagnostic testing industry with reference materials in an ISO 13485-registered facility.

Whether for genetic testing, cancer testing, or reproductive health testing, SeraCare can provide for all of your clinical reference material needs.

Contact us today for more information.

New call-to-action

Topics: clinical genomics