We have a dedicated department of quality professionals who manage and administer key elements of our QMS, such as:
- Licensure & credentialing
- Disaster recovery
- Proficiency testing
- Document control
- Training & competency
- Sample chain of custody
All tests are developed and validated in full compliance with all federal, state and local laws, rules and regulations, including CLIA, New York State, and CAP standards. Test performance is routinely and closely monitored to ensure the timely delivery of accurate test results to our clients and their patients.
All NeoGenomics clinical laboratory personnel are required to have appropriate credentials and experience to perform the tests provided by NeoGenomics. In addition, all NeoGenomics personnel are required to participate in continual training and competency programs to ensure that each employee remains proficient and qualified to perform all testing with optimal expertise.
NeoGenomics adheres to Lean and Six Sigma processes to ensure its continued excellence in services and reduce obstacles throughout our process. In addition, we regularly survey our clients and suppliers to make sure we maintain high levels of service.
Our Pathology Staff:
Our pathology staff have received in-depth training and are certified by equipment manufacturers to perform our FDA-approved companion diagnostic assays.
We use LabVantage® LIMS which is a 21CFR Part 11 compliant LIMS system.
NeoGenomics is a publicly traded company (NASDAQ:NEO) and abides by all regulations that help provide transparency to shareholders and investors. NeoGenomics has successfully completed four FDA audits at our Fort Myers and Aliso Viejo facilities with no FDA form 483’s.
2016 – Aliso Viejo
2016 - Fort Myers
2013 – Aliso Viejo
2011 – Aliso Viejo
Our medical and scientific staff of over 60 MD and PhD’s are well published and recognized industry leaders. They maintain membership in notable societies, such as:
- American Society of Hematology (ASH)
- College of American Pathologists (CAP)
- American Society of Clinical Oncology (ASCO)
- American Association of Cancer Researchers (AACR)
- American Society of Human Genetics (ASHG)
- And numerous others
NeoGenomics Operates Laboratories in:
Aliso Viejo, CA
Fort Myers, FL
Singapore, Republic of Singapore
Technology Platforms Center of Excellence
We validate assays on any of these widely used platforms: