Forensic drug testing is not specifically regulated. Information provided in this section pertains to regulations that apply to other types of laboratories.

Clinical Laboratory Improvement Amendments (CLIA)                                                                               Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research and forensic) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 175,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations has the responsibility for implementing the CLIA program.

The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.

College of American Pathologists (CAP)
The College of American Pathologists, the principal organization of board-certified pathologists, serves and represents the interest of patients, pathologists, and the public by fostering excellence in the practice of pathology and laboratory medicine.

CAP's Strategic Plan is intended to help ensure that the College fulfills its mission in a thoughtful and effective manner. The plan contains 13 specific directions that the College will follow in carrying out its commitment to members, their patients, and the public.

Department of Health and Human Services
The Department of Health and Human Services is the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. The Department includes more than 300 programs, covering a wide spectrum of activities including substance abuse treatment and prevention. One of its operating divisions, the U.S. Public Health Service, includes the National Institutes of Health (established in 1887, which includes 27 separate health institutes and centers, such as the National Institute on Drug Abuse), the Food and Drug Administration (established in 1906 and is responsible, in part, for marketing clearance of drug tests), the Substance Abuse and Mental Health Services Administration (established in 1992 and responsible for federal workplace drug testing regulations and certification of laboratories for such testing). The DHHS website does not have information specific to substance abuse, but does provide links to such information.

U.S. Department of Transportation (DOT)
The Department of Transportation Office of Drug & Alcohol Policy & Compliance (ODAPC) has its own set of regulations regarding drug testing within the transportation industries. The Omnibus Transportation Employee Testing Act of 1991 requires drug and alcohol testing of safety-sensitive transportation employees in aviation, trucking, railroads, mass transit, pipelines and other transportation industries. DOT publishes rules on who must conduct drug and alcohol tests, how to conduct tests and what procedures to use when testing. These regulations cover all transportation employers, safety-sensitive transportation employees and service agents—roughly 12.1 million people. Encompassed in 49 Code of Federal Regulations (CFR) Part 40, the Office of Drug & Alcohol Policy & Compliance publishes, implements and provides authoritative interpretations of these rules.

DOT has several sub-administrations: Federal Aviation Administration (FAA), Federal Railroad Administration (FRA), Research and Special Programs Administration (RSPA), dealing with pipelines, Federal Motor Carrier Safety Administration (FMCSA, previously the Federal Highway Administration), Federal Transit Administration (FTA), Coast Guard.

Health Insurance Portability and Accountability Act (HIPPA)
In the early 1970’s, Congress recognized that the stigma associated with substance abuse and fear of prosecution deterred people from entering treatment and enacted legislation that gave patients a right to confidentiality. For the almost three decades since the Federal confidentiality regulations (42 CFR Part 2) were issued, confidentiality has been a cornerstone practice for substance abuse treatment programs across the country.

In 1996, Congress passed the Administrative Simplification provisions of HIPAA to improve the efficiency and effectiveness of the nation’s healthcare system.

In December, 2000, the Department of Health and Human Services (HHS) issued the “Standards for Privacy of Individually Identifiable Health Information” final rule (Privacy Rule), pursuant to the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 45 CFR Parts 160 and 164, Subparts A and E. Substance abuse treatment programs that are subject to HIPAA must comply with the Privacy Rule.

National Institute on Drug Abuse (NIDA)
The National Institute on Drug Abuse, established in 1974, is one of the 27 Institutes in the National Institutes of Health. It is primarily a research organization. NIDA's mission is to lead the Nation in bringing the power of science to bear on drug abuse and addiction. NIDA supports over 85 percent of the world's research on the health aspects of drug abuse and addiction.

NIDA was given the responsibility for drafting the original federal workplace drug testing guidelines (the NIDA Guidelines) first issued in 1988. But in 1991, the Alcohol Drug Abuse and Mental Health Administration (ADAMHA) Reorganization Act created the Substance Abuse and Mental Health Services Administration (SAMHSA) which took over the administrative responsibilities for the federal workplace drug testing program and lab certification program from NIDA. NIDA remains as a research institute within the National Institutes of Health.

The NIDA website has a wealth of information on drugs-of-abuse, with special sections dedicated to researchers and health professionals, parents and teachers, and students. There are numerous publications and research reports which can be downloaded at no charge. There is a convenient pull-down menu allowing direct transfer to 18 sections on a variety of common drugs-of-abuse and related topics including drug testing.

U.S. Nuclear Regulatory Commission (NRC)
The Nuclear Regulatory Commission has established its own regulations regarding employee drug testing within the nuclear power industry. One key difference from other federal workplace drug testing programs is that it does allow for on-site testing (screening), although SAMHSA has recently proposed on-site testing for other federal workplace testing programs. The NRC drug-testing program has no direct bearing on criminal justice testing programs, but their distinct policies, especially allowing for on-site testing, may serve as useful example to support particular criminal justice drug testing policies and procedures.

Occupational Safety and Health Administration (OSHA)
OSHA recognizes that impairment by drug or alcohol use constitutes an avoidable workplace hazard and that drug-free workplace programs help improve worker safety and health and add value to American businesses. OSHA strongly supports comprehensive drug-free workforce programs, especially within certain workplace environments, such as those involving safety-sensitive duties like operating machinery. OSHA works closely with the U.S. Department of Labor’s Working Partners for an Alcohol- and Drug-Free Workplace program to help employers ensure that their health and safety plans are enhanced through workplace drug prevention. In particular, OSHA and Working Partners strive to raise awareness about the impact drugs and alcohol have on the workplace and provide information on how to establish drug-free workplace programs. A particular focus is placed on small businesses, since they are less likely than their larger counterparts to have mechanisms in place to prevent workplace substance abuse–despite being more likely to suffer from its negative impact. The web site can be searched for a variety of issues regarding drug use, drug testing, exposure to pathogens in handling urine specimens, etc.

Office of National Drug Control Policy (ONDCP)
The White House Office of National Drug Control Policy (ONDCP), a component of the Executive Office of the President, was established by the Anti-Drug Abuse Act of 1988. The principal purpose of ONDCP is to establish policies, priorities, and objectives for the Nation's drug control program. The goals of the program are to reduce illicit drug use, manufacturing, and trafficking; drug-related crime and violence; and drug-related health consequences. To achieve these goals, the Director of ONDCP is charged with producing the National Drug Control Strategy. The Strategy directs the Nation's anti-drug efforts and establishes a program, budget, and guidelines for cooperation among Federal, State, and local entities. The ONDCP website has numerous links to useful fact sheets on various drugs and drug issues, including a link to a comprehensive searchable file of street terms for drugs. http://www.whitehousedrugpolicy.gov/streetterms/

Substance Abuse and Mental Health Services Administration (SAMHSA)
SAMHSA was created in 1992 to focus attention, programs, and funding on improving the lives of people with or at risk for mental and substance abuse disorders. SAMHSA has three centers, the Center for Substance Abuse Prevention (CSAP, http://www.prevention.samhsa.gov), the Center for Substance Abuse Treatment (CSAT, http://csat.samhsa.gov) and the Center for Mental Health Services (CMHS, http://mentalhealth.samhsa.gov/). The Center for Substance Abuse Prevention is responsible for the management of federal workplace drug testing programs and also certifies laboratories to perform such testing. The list of certified laboratories (numbering 50 as of 1/05) is published in the Federal Register at the beginning of each month. The lab list is also available at http://workplace.samhsa.gov/ResourceCenter/lablist.htm.

The Division of Workplace programs website http://workplace.samhsa.gov/ has useful information on drug testing programs, regulations, policies and procedures for drug testing of federal workplace employees. The website also has a Resources and Tools section. http://workplace.samhsa.gov/ResourceCenter/category.asp

The Center for Substance Abuse Prevention also supports the National Clearinghouse for Alcohol and Drug Information (NCADI), the largest Federal source of information about substance abuse research, treatment, and prevention available to the public. http://www.ncadi.samhsa.gov/.

Finally, SAMHSA’s Office of Applied Studies (OAS) gathers, analyzes, and disseminates data on substance abuse practices in the United States. OAS is responsible for the annual National Household Survey on Drug Abuse, the Drug Abuse Warning Network, and the Drug and Alcohol Services Information Services System, among other studies.

Drug testing programs are also provided through state legislation. For more information, visit: http://www.findlaw.com/ or http://www.caselaw.com/.