Federal Laboratory Accreditation/Acceptance and Recognition Programs

Overview

Laboratory Accreditation is formal confirmation by a third-party that a laboratory has demonstrated its competence to carry out specific laboratory tasks. Laboratory Acceptance generally involves a less rigorous evaluation of a laboratory's competence. In some cases, federal agencies do not accredit laboratories directly. Instead, the agencies recognize laboratory accreditation bodies and the laboratories accredited by those bodies.

Requirements for laboratory acceptance/accreditation/recognition programs within the federal government vary greatly by program. While some programs are quite comprehensive, others involve only minimal review of a laboratory's or the laboratory accreditation body's qualifications. The requirements and scope of each program generally are tailored to meet specific agency needs. In some cases, the laboratories provide only an initial product screening, with federal laboratories maintaining final responsibility for producing the test data used in enforcing regulations. Eligibility requirements for acceptance/accreditation as well as for the recognition of laboratory accreditation programs also vary among programs.

Below are websites for various federal laboratory accreditation/acceptance and recognition programs.

U.S. Consumer Product Safety Commission (CPSC)

The Laboratory Accreditation Registration System for Third Party Testing Laboratories is a web-based application supporting the registration of third party laboratories seeking accreditation to test children's products for conformity with the Commission's regulations. These laboratories must be accredited by an International Laboratory Accreditation Cooperation - Mutual Recognition Arrangement (ILAC-MRA) signatory accrediting body and the accreditation must be registered with, and accepted by, the Commission.
 

U.S. Department of Agriculture

• AMS (Agricultural Marketing Service)
  The Agricultural Marketing Service (AMS) administers programs that create domestic and international marketing opportunities for U.S. producers of food, fiber, and specialty crops. AMS also provides the agriculture industry with valuable services to ensure the quality and availability of wholesome food for consumers across the country and around the world.
• APHIS (Animal and Plant Health Inspection Service) The APHIS approves laboratories to conduct tests for certain types of diseases where such tests must be performed at either the National Veterinary Services Laboratories or other APHIS-approved facilities. Some testing is performed only by laboratories in the National Animal Health Laboratory Network.
• FSIS (Food Safety and Inspection Service) The FSIS operates a pilot program involving federal food laboratories at FDA, and the US Army; and some state food laboratories to become accredited under ISO 17025.
• FSIS: Accredited Laboratory Program FSIS accredits analytical chemistry laboratories to analyze meat and poultry food products for moisture, protein, fat, and salt content and/or certain classes of chemical residues.
• National Seed Health System Accredits public and private entities to perform laboratory seed health tests and phytosanitary inspections to meet international import regulations.

U.S. Department of Commerce, National Institute of Standards and Technology (NIST)

• National Voluntary Laboratory Accreditation Program (NVLAP) NIST accredits testing and calibration laboratories.
• National Voluntary Conformity Assessment System Evaluation (NVCASE) Program NIST's NVCASE Program evaluates and recognizes organizations which support conformity assessment activities. NVCASE recognition may be sought by a body that accredits other bodies, (i.e., an accreditor of laboratories, certifiers or registrars).
• Standard Reference Materials (SRM) Program Operates NIST's Gas Mixture Traceable Reference Material NTRM® program that consists of commercially produced reference materials with a well-defined traceability linkage to existing NIST standards.
• Office of Weights and Measures: State Laboratory Program NIST's State Laboratory Program has developed performance standards and formalized procedures for Recognition of State legal metrology laboratories on a voluntary basis.
• USGv6 Testing Program  OMB Memorandum M-05-22 directs NIST to develop the technical infrastructure (standards and testing) necessary to support wide sIPv6 in the US Government.

U.S. Department of Defense

• Army Corps of Engineers: Materials Testing Center The Army Corps of Engineers validates commercial laboratories in accordance with ER 1110-1-261 to perform the Army Corps work for CONUS MSCs.
• Environmental Laboratory Accreditation Program Using third-party Accreditation Bodies (ABs), the DoD ELAP provides a unified DoD program through which laboratories can demonstrate competency and document conformance to the DoD Quality Systems Manual for Environmental Laboratories (DoD QSM).

U.S. Department of Health and Human Services (HHS)

• CMS (Centers for Medicare and Medicaid): Clinical Laboratory Improvement Act (CLIA) Program Certifies/accredits all laboratories that perform testing on human specimens for the purpose of diagnosing or treating a disease, illness, or assessment of the health of human beings. Also recognizes other private sector laboratory accreditation program for purposes of the CLIA.
• CMS: Cytology Proficiency Testing Program Approves proficiency testing programs for individuals engaged in the examination of gynecologic preparations.
• Workplace Drug Testing Program HHS notifies Federal agencies of the laboratories currently certified by the HHS National Laboratory Certification Program (NLCP) to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs.
• FDA (Food and Drug Administration): Interstate Milk Shippers Program Maintains a list of milk laboratories approved by federal and state agencies.
• FDA: Good Laboratory Practice (GLP) for Nonclinical Laboratories Nonclinical laboratory studies are experiments that study test articles (food additives, color additives, drug or biological products, electronic products, medical devices for human use) in test systems (animals, plants, microorganisms, or subparts thereof) under laboratory conditions to determine their safety. FDA inspects facilities that conduct nonclinical laboratory studies to determine compliance with Part 58 (GLP for Nonclinical Laboratory Studies) of Title 21 of the Code of Federal Regulations.
• Centers for Disease Control and Prevention (CDC): Model Performance Evaluation Program (MPEP) The MPEP evaluates the performance of laboratories conducting testing to detect human immunodeficiency virus type 1 (HIV-1) antibody (Ab) by traditional testing methods (enzyme immunoassay, Western blot, etc.). The MPEP now includes evaluation of laboratory/testing site performance for HIV Ab by rapid testing methods and mycobacterium-related tests.
• Office of the National Coordinator (ONC) for Health Information Technology: Temporary Certification Program for Health Information Technology This temporary certification program provides a process by which an organization or organizations may become an ONC-Authorized Testing and Certification Body (ONC-ATCB) and be authorized by the National Coordinator to perform the testing and certification of Complete Electronic Health Records (EHRs) and/or EHR Modules.

U.S. Department of Homeland Security

• U.S. Customs and Border Protection (CBP) The CBP accredits commercial testing laboratories and commercial gaugers.
• U.S. Coast Guard Independent laboratories conduct initial (approval) and follow-up (production) testing of equipment and materials that require Coast Guard Approval. Accepted and recognized independent laboratories act on behalf of the Coast Guard during the approval of lifesaving and fire protection equipment and materials.

U.S. Department of Transportation

• Federal Highway Administration (FHWA): Quality Assurance: Laboratory Qualification The FHWA regulation for construction requires accreditation of the central laboratory of each State Department of Transportation (DOT) and all Non-State-DOT laboratories that perform independent assurance testing or testing for dispute resolution. The regulation requires accreditation "by the American Association of State Highway and Transportation Officials (AASHTO) Accreditation Program or a comparable laboratory accreditation program approved by the FHWA."
• Office of Hazardous Materials Safety: UN Third Party Certification Agencies Approval may be granted to an organization or a person to conduct package testing as a DOT Approved UN Third Party Certification Agency. Package testing may be conducted for either manufacturers of packaging or for shippers of hazardous materials and a certification made that the packagings are in full compliance with requirements. Approvals are granted based upon the technical qualifications of the applicant as well as the results of an in-person inspection to determine the capability of the laboratory in which the package testing would be taking place
• Office of Drug & Alcohol Policy & Compliance DOT publishes rules on who must conduct drug and alcohol tests, how to conduct those tests, and what procedures to use when testing. Laboratories are certified by the Substance Abuse and Mental Health Services Administration/HHS.

U.S. Environmental Protection Agency

• National Environmental Laboratory Accreditation Program (NELAP) Program under the NELAC Institute (TNI) NELAP relies on consensus standards representing the best professional practices in the industry to establish the requirements for this program, which is then implemented by state agencies recognized by The NELAC Institute (TNI) as Accreditation Bodies.
• Drinking Water Laboratory Approval Program EPA accredits laboratories to conduct analyses on drinking water.
• UCMR Laboratory Approval Program EPA approves laboratories to conduct analyses of contaminants covered in its Unregulated Contaminant Monitoring Regulation (UCMR).
• Information Collection Requirements (ICR) for Drinking Water Laboratories EPA approves laboratories for specific data accuracy and precision requirements for public drinking water systems.
• Other Drinking Water-Related Laboratory Approval Programs - EPA approves laboratories to test for contaminants not covered under State drinking water certification programs. Laboratories that analyze source water samples for Cryptosporidium must be approved by EPA under its Cryptosporidium Laboratory Quality Assurance Program.
• ENERGY STAR Program EPA established the Conditions and Criteria for Recognition of Laboratories Accreditation Bodies (ABs) for the ENERGY STAR program. Recognized ABs must be a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement (MRA), meet the requirements of ISO 17011, and comply with the specific conditions of the ENERGY STAR Laboratory Accreditation Requirements.
• WaterSense Program EPA develops criteria for the inspection, labeling, and oversight of new homes for the WaterSense program.

U.S. Department of the Treasury

• Alcohol and Tobacco Tax and Trade Bureau The Treasury Department operates a laboratory certification program that certifies laboratories that test wines and spirits for export to foreign markets.