Laboratories that operate under CLIA adhere to established regulations for laboratory testing quality and for reporting patient-specific results. Being CLIA certified and CAP accredited demonstrates that your facility meets the federal regulations and standards for clinical diagnostic testing, ensuring quality and safety in the laboratory. Navigating this compliance landscape, with its many acronyms, can be confusing. Continue reading to get more clarity on the topic.
Clinical Laboratory Improvement Amendments (CLIA)
Consist of a set of federal standards that are overseen by the FDA, CMA, and CDC. The FDA categorizes tests as waived, moderate, or high complexity based on certain criteria that determine their applicable CLIA requirements. The Centers for Medicare & Medicaid Services (CMS) ensures basic CLIA requirements are met within a laboratory, such as having an appropriate facility, a qualified lab director, and an adequate description of assays being performed. The CDC supports the CLIA program through the development of quality improvement studies, laboratory standards and guidelines, proficiency testing practices monitoring, and more. Any testing performed in the U.S. that yields results used to direct patient care must comply with CLIA standards.
COLA or CAP Accreditation
COLA accreditation is approved for core lab specialties including chemistry, microbiology, immunology, blood bank, urinalysis, and hematology. A COLA surveyor conducts an on-site inspection to issue an accreditation certificate valid for two years. For CAP accreditation, detailed checklists must be completed for regulatory adherence as it has more specialty-specific quality standards than other accreditation organizations. CAP inspections are done every two years and a self-inspection every other year. It’s important to note that the Laboratory Director must also be qualified and hold the certificates relevant to the specific categories of testing performed in the laboratory.
Our Laboratory Consulting Services can handle the processing and enrollment for CLIA certificates and other state license certifications including CAP and COLA. Being an accredited laboratory means you use the most comprehensive, scientifically-endorsed laboratory standards to meet or exceed CLIA standards and requirements. This gives customers the confidence that their testing will stand up to strict regulatory scrutiny. Contact us to discuss other regulatory questions.