US Regulations on Registered Clinical Laboratories: "The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 189,000 laboratory entities. The objective of the CLIA program is to ensure quality laboratory testing." Labs maintain their CLIA certification by routinely running proficiency panels in the same manner as patient samples. ATCC, though not participating directly in the business of proficiency testing, does supply much of the "raw" material used in the panels.
In 2005 a public health incident occurred regarding the accidental release of a non-circulating H2N2 influenza strain into a viral proficiency panel. Although ATCC was in no way responsible for this hazardous event, the U.S. Department of Health and Human Services (HHS) requested help from ATCC to ensure a similar event does not recur.
In response to HHS, and in line with our continuous effort to protect public health, safety and the environment, we have developed the ATCC Proficiency Standard program. By providing dedicated proficiency testing stocks that are lot- and vial-traceable and accompanied by a detailed Certificate of Analysis, this program will ensure that standard starting materials for proficiency testing (PT) panels are available, under a license agreement, for PT service providers and manufacturers to order. The chain-of-custody established by the ATCC Proficiency Testing Standard program will help ensure that proficiency testing panels are consistent, safe, reliable and traceable to their source.