Functional Biosciences announced Friday it has been awarded its CLIA Certification of Compliance from the Wisconsin Department of Health, a necessary “gold standard” for laboratories that accept human samples.
The Madison-based laboratories achieved CLIA accreditation in 2016 and the compliance certificate endorses the Functional Biosciences laboratories achievement in the federal standards of quality, management and processes in human sample diagnostics.
“Serving our clients that need validation of their clinical tests using Sanger Sequencing in a CLIA-environment is just the first step towards broadening our client base.” said Michael Flanagan, president of Functional Biosciences. “Demand for the Sanger sequencing we perform will continue to grow and we are dedicated to expanding our services in this arena while providing the highest level of customer service.
Laboratory Director Kym Larson manages the processes and quality control that Functional Biosciences must execute to garner expanded service offerings.
“Accreditation from the College of American Pathologists this spring will prove our commitment to quality and will bring our labs an international stamp of approval,” Larson said. “Our technicians, experts in clinical diagnostic sequencing, are ready for the expanded projects the accreditation will bring from hospitals and the forensic arena.”
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Standards of quality must be met for proficiency testing, patient test management, quality control, personnel qualifications, and quality assurance. Learn more: https://wwwn.cdc.gov/clia/
About CAP Accreditation
The College of American Pathologists (CAP) accreditation is an internationally recognized standard of operational excellence. The U.S. federal government recognizes the CAP Laboratory Accreditation Program, begun in the early 1960s, as being equal to or more stringent than the government’s own inspection program. During the CAP accreditation process, designed to ensure the highest standard of care for all patients, inspectors examine the laboratory’s records and quality control of procedures, including staff qualifications, equipment and more. Learn more: www.cap.org
About Functional Biosciences Inc.
Functional Biosciences, Inc., is a biotechnology company that specializes in Nano-preparative approaches to Sanger DNA Sequence analysis. The Wisconsin-based laboratories offer Sanger DNA sequencing, PCR, Fragment Analysis, Plasmid Purification, Primer Walking, SNP Analysis, Capillary Electrophoresis and Picking & Growing Colonies. Functional Biosciences is a small business organization that works with a variety of clients including universities, corporations and governments world-wide. The laboratories are staffed with CLIA and CAP-qualified technicians that take pride in giving white-glove customer service.
Distributed through the Wisconsin Technology Council News Service