ATCC® Proficiency Standard® Program

The goal for the ATCC® Proficiency Standard® Program is to positively impact the public health, welfare and safety by providing standardized biological materials in line with a program that addresses the need for security and traceability in the proficiency testing sector.

If you are interested in participating in the Proficiency Standard Program, contact us via e-mail at standards@atcc.org. If you are currently a PTS participant, related results will appear within your website search results if you are logged-in.

Background

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.

The Program 

  • Institutes a process where material ordered from ATCC is agreed upon by the proficiency testing service providers, segregated and licensed only to registered manufactures of proficiency testing panels
  • Provides dedicated stocks of biological materials manufactured, labeled and numbered to afford lot- and vial-traceable proficiency standards for manufacturers to order specifically for proficiency testing
  • Provides secure Web access to search for and order Proficiency Standard products, extending user accounts and log-ins to restrict users to items specified in their license agreement
  • Includes traceable supporting documentation with each order — a detailed product information sheet and Certificate of Analysis
  • Assures proficiency panels traceable to their source by maintaining a chain-of-custody from proficiency standard to proficiency panel
  • Requires one-time only (panel) use of each ATCC Proficiency Standard vial
  • Requires destruction of all material not used in the designated proficiency panel
  • Assists proficiency testing service providers by enabling acquisition of new organisms necessary for upcoming or new proficiency panels
  • Provides needed regulation of the proficiency testing industry
  • Gives increased protection to laboratory end-users
  • Reduces risk of liability for proficiency testing service providers and manufacturers

Program Users

  • Proficiency testing service providers select specific proficiency standards
  • Manufacturers use proficiency standards to produce proficiency testing panels
  • End-users laboratories use proficiency panels in their required and elective testing. End-users are all laboratories where proficiency testing is performed, including clinical, physician pharmaceutical development and QC laboratories/li>

The following organizations are participants in this program:

    If you are interested in participating in the Proficiency Standard Program, contact us via e-mail at standards@atcc.org.