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Adulterated specimen: A specimen that contains a substance that is not expected to be present in human urine, or contains a substance expected to be present but is at a concentration so high that it is not consistent with human urine.

Antigen: A substance that when introduced into the body stimulates the production of an antibody. Antigens include toxins, bacteria, foreign blood cells, and the cells of transplanted organs.

Blind specimen or blind performance test specimen: A sample specimen, either negative or “spiked” with a drug, submitted to a laboratory, as a donor specimen, used for quality control testing purposes. It is done in a manner so that the laboratory cannot distinguish it from an employee specimen.

Cancelled test: A drug or alcohol test that has a problem identified that cannot be or has not been corrected, or which this part otherwise requires to be cancelled. A cancelled test is neither a positive nor a negative test.

Chain of custody (COC): The procedure used to document the handling of the urine specimen from the time the donor gives the specimen to the collector until the specimen is destroyed. This procedure uses the Federal Drug Testing Custody and Control Form (CCF).

Collection container: A container into which the employee urinates to provide the specimen for a drug test.

Collection site: A place selected by the employer where the donor is sent for the purpose of providing a urine specimen for a drug test.

Collector: A person who instructs and assists employees at a collection site, who receives and makes an initial inspection of the specimen provided by those employees, and who initiates and completes the CCF.

Confirmation (or confirmatory) drug test: A second analytical procedure performed on a urine specimen to identify and quantify the presence of a specific drug or drug metabolite.

Confirmation (or confirmatory) validity test: A second test performed on a urine specimen to further support a validity test result.

Confirmed drug test: A confirmation test result received by an MRO from a laboratory.

Consortium/ Third-party administrator (C/TPA): A service agent that provides or coordinates the provision of a variety of drug and alcohol testing services to employers. C/TPAs typically perform administrative tasks concerning the operation of the employers' drug and alcohol testing programs.

Continuing education: Training for medical review officers (MROs) and substance abuse professionals (SAPs) who have completed qualification training and are performing MRO or SAP functions, designed to keep MROs and SAPs current on changes and developments in the DOT drug and alcohol testing program.

Creatine: A white crystalline nitrogenous substance C4H9N3O2 found especially in the muscles of vertebrates either free or as phosphocreatine.

Cutoff Level (Threshold): The defined concentration of a substance in a specimen at or above which the test is called positive and below which it is called negative. This concentration is usually significantly greater than the sensitivity of the assay.

Designated employer representative (DER): An employee authorized by the employer to take immediate action(s) to remove employees from safety-sensitive duties, and to make required decisions in the testing and evaluation processes. The DER also receives test results and other communications for the employer, consistent with the requirements of this part. Service agents cannot act as DERs.

Dilute specimen: A specimen with creatine and specific gravity values that are lower than expected for human urine.

DOT: The Department of Transportation: These terms encompass all DOT agencies, including, but not limited to, the United States Coast Guard (USCG), the Federal Aviation Administration (FAA), the Federal Railroad Administration (FRA), the Federal Motor Carrier Safety Administration (FMCSA), the Federal Transit Administration (FTA), the National Highway Traffic Safety Administration (NHTSA), the Research and Special Programs Administration (RSPA), and the Office of the Secretary (OST). These terms include any designee of a DOT agency.

Drug Free Workplace Act: The 1988 Federal act that laid the groundwork for subsequent regulation of workplace drug testing.

Gas Chromatography: A process in which the specimen is vaporized and injected into a stream of carrier gas (as nitrogen or helium) moving through a column containing a stationary phase composed of a liquid or particulate solid and is separated into its component compounds.

HHS: The Department of Health and Human Services or any designee of the Secretary, Department of Health and Human Services.

Immunoassay: A laboratory technique that makes use of the binding between an antigen and its antibody in order to identify and quantify the specific antigen or antibody in a sample.

Initial Test

Invalid drug test: The result of a drug test for a urine specimen that contains an unidentified adulterant or an unidentified interfering substance, has abnormal physical characteristics, or has an endogenous substance at an abnormal concentration that prevents the laboratory from completing or obtaining a valid drug test result. There can be several reasons for an invalid or unsuitable result.

Examples include:

  • Not suitable for testing
  • pH is out of range
  • Temperature of the specimen is out of range
  • GC/MS interference
  • Immunoassay interference
  • Interfering substance
  • Bottle A and B have different physical characteristics
  • Creatinine < or = 5 but the specific gravity is within normal limits

Laboratory: Any U.S. laboratory certified by HHS under the National Laboratory Certification Program as meeting the minimum standards of Subpart C of the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs.

Mass Spectrometry: An instrumental method used in conjunction with Gas Chromatography that provides accurate information about the molecular mass and structure of complex molecules. This technique can identify and quantify extremely small amounts of drugs or metabolites by their mass-fragment spectrum.

Medical Review Officer (MRO): A licensed medical doctor specially trained in substance abuse who is responsible for receiving, interpreting, and evaluating drug test results.

Negative Result: A negative determination by the laboratory or Medical Review Officer, for the presence of drugs, not prescribed, for which the specimen was tested.

Metabolite: A compound produced from the chemical changes of a drug in the body.

Observer: In drug testing, the individual who watches the donor urinate into a collection container or specimen bottle when a direct-observed collection is required.

Positive Result: A positive laboratory test result is determined as a "Positive" by the MRO if the donor is unable to provide a valid alternative medical explanation for the presence of a drug found in the donor specimen.

Primary specimen: In drug testing, the urine specimen bottle that is opened and tested by a first laboratory to determine whether the employee has a drug or drug metabolite in his or her system; and for the purpose of validity testing. The primary specimen is distinguished from the split specimen, defined in this section.

Shy Bladder: Generally, the term "shy bladder" refers to an individual who is unable to provide a sufficient urine specimen for testing either due to physical reasons, or avoidance of testing.

Specimen bottle: The bottle that, after being sealed and labeled according to proper procedure, is used to hold the urine specimen during transportation to the laboratory.

Split specimen: A part of the urine specimen that is sent to a laboratory and retained unopened, which is transported to a second laboratory, if the donor requests that a second test be conducted a verified positive test of the primary specimen, or a verified adulterated or substituted test result.

Stand-down: The term for temporarily removing an employee from the performance of safety-sensitive functions based only on a report from a laboratory to the MRO of a confirmed positive test for a drug or drug metabolite, an adulterated test, or a substituted test, before the MRO has completed final verification of the test result.

Substance Abuse Professional (SAP): A person who evaluates employees who have violated a DOT drug and alcohol regulation and makes recommendations concerning education, treatment, follow-up testing, and aftercare.

Substituted specimen: A specimen with creatinine and specific gravity values that are so diminished that they are not consistent with human urine.

Verified test: A drug test result or validity testing result from an HHS-certified laboratory that has undergone review and final determination by the MRO.