As a 7,500-square-foot program component for the design of a larger cytology and oncology diagnostic facility, Genoptix required a certified CLIA (Clinical Laboratory Improvement Amendments) laboratory.
Criteria included conformance to CDC’s Standards and Certification: Laboratory Requirements (42 CFR 493) issued by the Centers for Medicare & Medicaid Services (CMS), with particular design attention to criteria in Section 493.111, Facilities Administration.
The design solution was coordinated with laboratory managers to ensure sample flows were uni-directional within the CLIA labs, that space planning segregated this function from other testing operations to avoid cross-contamination and that relative air pressurization and filtration was appropriate to the diagnostic procedures.
CLIA inspections and subsequent certification were completed and achieved in Q4 2013.
