If you’re planning on opening or have an existing lab, we are here to assist you through navigating CLIA or staying CLIA Accredited.
Contact one of our many qualified Laboratory Technical Consultants. We will be happy to assist with CLIA application questions, instrument decisions, validations, staffing, lab director search or items related to running your lab.
There are several pathways for a lab to obtain a CLIA Certification. A lab may apply for a Certificate of Waiver, for simple laboratory examinations and procedures that provide insignificant risk to the patient or rendering of erroneous results. Labs that perform more complex tests, moderate or highly complex, will apply for a Certificate of Compliance. Labs may pursue a Certificate of Accreditation which requires a lab to go above addressing basic CLIA compliance regulations and adds more stringent expectations of a labs quality system.
There are seven approved Accreditation agencies that have been approved under OMB control number 0938-0686:
- Association for the Advancement of Blood & Biotherapies (AABB)
- American Assessment for Laboratory Accreditation (A2LA)
- Accreditation Commission for Health Care, Inc (ACHC)
- American Society for Histocompatibility and Immunogenetics (ASHI)
- The Commission on Office Laboratory Accreditation (COLA)
- College of American Pathologists (CAP)
- Joint Commission (JC)
Compliance Services from the National Network:
Certificate of Compliance Binder – $2,500
Waived Lab Binder – $500
PPM Binder – $500