How Otogenetics Became Audit-ready

by Brantley Wyatt on April 16, 2015 in Genomics
Otogenetics readying for their CLIA compliance auditOtogenetics readying for their CLIA compliance audit

In this short question and answer session, Brantley Wyatt, Senior Project Technician at Otogenetics, discusses Otogenetics and the steps they took to get ready for their CLIA audit. For more information about Otogenetics, visit their website.

Brantley

Brantley Wyatt

Q: What does Otogenetics do?

A: At Otogenetics, we process almost 4,000 samples a year, mostly whole-exome disease panels, deafness testing, or RNA sequencing. We are a CLIA-registered NGS service provider, and have the fastest sample turnaround time in the industry, ranging between 4 and 6 weeks. Currently, we are preparing for full CLIA certification.

Q: What is your role?

Miseq

Illumina (r) MiSeq at Otogenetics

A: As the Senior Project Technician at Otogenetics, I’m the first stop for these samples because I perform the initial QC and library prep. It’s also in my purview to oversee the entire sample pipeline. At any point, I’m aware of where these samples reside in the pipeline because we use a LIMS.

Q: Why did you decide to invest in a LIMS?

A: Previously, Otogenetics managed samples by using a system of Excel spreadsheets. Ultimately this system worked because we were always able to get customers information about their samples and produce accurate sample results, but it was time-consuming because the system of spreadsheets wasn’t entirely searchable. Otogenetics invested in a LIMS to help with sample tracking and become CLIA certified.

Robot

Robotics in use at Otogenetics

Q: How has the LIMS helped you?

A: Since we offer many types of disease panels, we have a diverse customer base, including pharmaceutical companies, healthcare providers, large medical centers, and individuals. And right now, we process a mix of both research and clinical samples. With so much diversity and a large sample volume, we must have efficient methods for prepping samples, processing them, and following them through the lab. The LIMS has streamlined our intake process with barcode scanning and the autopopulation of data throughout the system. Likewise, customers can directly upload their sample information to the collaboration portal in the LIMS. Overall, less data entry reduces the potential for error, and it also saves roughly 15 minutes per sample. Over 4,000 samples, savings add up and enable us to focus our efforts on more samples and other important tasks.

The LIMS also helps us track samples from receipt to end result. No matter where a sample is in the pipeline, I can search for it, know where it is, what has been done to it, and who has done it. I can even produce a human-readable audit trail. With a lab staff of six, this is a time saver – we no longer have to hunt through Excel spreadsheets.

bench2

Lab at Otogenetics

As the person who is in charge of keeping samples moving through our pipeline, the dashboard feature in the LIMS is also invaluable. That’s always the first place I go to every day – to see what is in the works, what needs my attention, and so forth.

Q: What advice would you give to labs that might be embarking on the certification process?

A: I recommend the following, basic approach:

  1. Give yourself plenty of time. Start preparing for the inspection well in advance as there will inevitably be something unexpected that comes up that takes time to resolve.
  2. Assign someone to be a compliance leader that can be in charge of delegating tasks in advance of inspection.
  3. Make sure all documentation is detailed, thorough, and in order. A LIMS system can aid in this as it provides a centralized location for all the processes, reagent kits, lot numbers, etc. that are used for a given sample and can give us a report on any given set of samples.

For information about Otogenetics, read their story.

Read their story

Share