In recognition of the fact that the Clinical Laboratory Reference System has requirements that are equal to or more stringent than the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the System was granted exempt status by the federal Centers for Medicare and Medicaid Services (CMS) in 1995.
As a result, laboratories located in New York State meet CLIA accreditation requirements, as documented by a valid New York State permit, which includes a CLIA number.
Laboratories must enroll in CMS-approved proficiency testing program to meet CLIA proficiency test requirements.
For laboratories located in other states, eligibility for CLIA certification remains the responsibility of each state’s regional CMS office.
Laboratories located in New York State are still subject to validation inspections performed by CMS staff and all records maintained by New York State regarding a laboratory are subject to disclosure to CMS.