Drug Testing Terminology
49 CFR Part 40: A DOT regulation that specifies how workplace drug and alcohol testing should be conducted and under what conditions an employee can be returned to duties after they have violated drug and alcohol regulations. 49 CFR Part 40 applies to all modes of federally regulated transportation.
Accession number: An alpha-numeric code assigned to a lab sample that allows the lab technician to match the sample with the donor while still maintaining the donor’s privacy. At the end of the process, the employer or agency that ordered the test is able to match the assigned code with the donor, ensuring the donor’s privacy as the specimen passes through the laboratory and testing process.
Adulterated specimen: A urine or oral fluid specimen that has been altered or tampered with in some way in an effort to prevent a positive drug screen. There are a variety of ways in which a specimen can be altered, including substitution (using someone else’s urine instead of the person being tested), addition of commercially sold “masking agents,” or dilution of the sample (watering it down–internally or externally). A validity test is often the first step in a drug test, in order to determine whether the sample is valid for testing. If the initial test shows the sample to be adulterated, a second validity test may be conducted in order to confirm these findings.
Affidavit:A legal document, usually a written statement, that certifies that the information being given is true and accurate. It is enforceable by law and can be used in court. An affidavit must be signed voluntarily and in the presence of a notary public or other similar court official. Affidavits are required in DOT drug testing scenarios where a collector has made a “correctable flaw” and the collector attests to the missing or incorrect information. The Federal Transit Administration provides an example “Collection Site Drug Test Affidavit” form visit: (external link to download)
Air Blank: A test of a sample of air around a testing device conducted by an Alcohol Screening Device (ASD) or an Evidential Breath Testing Device (EBT) used to verify that there is no residual alcohol in the device from a previous test and that there is no alcohol in the environment that could affect the accuracy of the test. The ability to perform an air blank prior to a confirmation test is one of the requirements to be listed on the National Highway Traffic Safety Administration’s Conforming Products List (NHTSA CPL) as an approved Evidential Breath Testing (EBT) device.
Alcohol Screening Test: In workplace testing, the Alcohol Screening Test is an initial test to determine if there may be any alcohol in the breath or saliva of an employee selected for testing. The concentration of alcohol in the breath or saliva is correlative of the concentration of alcohol in the blood; however, saliva may only be used for initial testing (called a screening), not for confirmation. No action may be taken or determination may be made based on the results of a screening test alone as one test does not rule out all possible external influences on the testing process such as the recent use of hand sanitizer or listerine. A device used to conduct an Alcohol Screening Tests only is called an Alcohol Screening Device (ASD), a device that can conduct both the screening and the confirmation test is called an Evidential Breath Testing device or EBT device.In general medical applications, an alcohol screening test is a brief survey tool that is often used by physicians to help determine a person’s level of alcohol dependence. This screening tool can help a person determine whether they are likely to have a drinking condition, but it can also help determine a person’s risk of developing alcohol dependence in the future. A person that is determined to be at risk may need further testing in order to establish a diagnosis.
Alcohol Confirmation Test: A confirmation test is generally performed after an initial screening test has produced a positive result for alcohol. In order to rule out any concern that the initial test was positive due to residual mouth alcohol or other external influences, the alcohol technician must wait 15 minutes after the first screen before conducting the alcohol confirmation test. Using an Evidential Breath Testing device (EBT) approved by the National Highway Traffic Safety Administration (NHTSA) on their Conforming Products List (CPL) that prints results and can distinguish between alcohol (ethanol) and other similar compounds like acetone/ethyl acetate (chemicals sometimes produced by diabetics) is the most definitive method of conducting an alcohol confirmation test and is therefore required by the DOT. The current list of approved EBT devices can be found here: https://www.transportation.gov/odapc/approved-evidential-breath-testing-devices
Alcohol Testing Devices
Alcohol Screening Device (ASD): A variety of different devices that may be used to screen for alcohol on the breath or in bodily fluids such as saliva. The DOT utilizes the National Highway Traffic Safety Administration’s Conforming Products List (NHTSA CPL) published on the federal register for its list of approved Alcohol Screening devices. These devices can only perform the initial alcohol screening test. If the screening device detects alcohol above the limit defined then a confirmation test must be conducted using an Evidential Breath Testing (EBT) device.
Evidential Breath Testing Device (EBT): An EBT device measures the alcohol level of a person by measuring the concentration of alcohol in the breath. The concentration of ethanol (alcohol) in the breath (particularly the “alveolar breath” or deep lung air) correlates to the concentration of alcohol in the blood; therefore, it is possible to measure blood alcohol levels with this device. EBT devices that appear on the National Highway Traffic Safety Administration’s Conforming Products list (NHTSA CPL) are approved by the DOT. Some of the requirements to be published on the NHTSA CPL as an approved EBT are an ability to provide a print out of the results, ability to distinguish between ethanol and acetate/acetone, ability to conduct an air blank prior to a confirmation test, and an ability to assign a unique test number to each test conducted.
Alcohol Testing Site: The location where workplace alcohol testing is conducted by a Breath Alcohol Technician (BAT) or Screening Test Technician (STT).
Alcohol Testing Technicians:
Breath Alcohol Technician (BAT): A BAT conducts alcohol screening and confirmation on behalf of the employer under the required protocols for testing. A DOT qualified BAT will be capable of conducting alcohol screening and confirmation under DOT protocols in accordance with the 49 CFR Part 40. This technician offers instruction and assistance to employees during the alcohol testing process and can only operate the ASD (alcohol screening device) or EBT (evidential breath testing device) they are trained on.
Screening Test Technician (STT): An STT is an alcohol testing technician who is qualified only to conduct an initial test (known as an alcohol screening test) using an Alcohol Screening Device (ASD). Since the ASD can only conduct a screening and not the confirmation, the STT can’t conduct a confirmation test which must be conducted by a Breath Alcohol Technician (BAT) using an Evidential Breath Testing (EBT) device when a screening result exceeds the minimum breath alcohol concentration (BrAC).
Blind Specimen: A blind specimen, also called a blind performance test specimen, is used to ensure quality control in a laboratory environment. The specimens are submitted under a false name so that they cannot be distinguished from other valid specimens. These blind specimens will include both positive and negative (adulterated) samples that are chosen to target specific drugs. This ensures that the chosen lab maintains an accurate testing environment and that all test results are valid and dependable. In November of 2017 the DOT published changes to the 49 CFR Part 40 which, effective January of 2018, removes the requirement for blind specimen testing of laboratories certified by SAMHSA.
Breath Alcohol Concentration (BrAC): A measure of the amount of alcohol in a person’s breath. By measuring the level of alcohol present in the breath, it is possible to use a conversion factor called the blood:breath ratio to determine a person’s blood alcohol level (BAC). It is often measured by what is referred to as a “breathalyzer” test.
Cancelled Test: A cancelled test is found to be neither positive nor negative by the lab. There are a variety of issues that can cause a laboratory to cancel a test and may require the employee to submit another specimen for testing. A cancelled test cannot be held against an employee; however, it also does not count toward compliance with DOT requirements or an employer’s minimum random testing rate. If the test is cancelled as a result of collector error, that collector must undergo “error correction training” in accordance with 49 CFR Part 40.33.
Chain of Custody: A set of protocols put into place to reduce the chances that anything could happen to interfere with a test such as substitution, adulteration, or other possible negative outcomes such as a lost specimen. Because the results of a drug or alcohol screen can have life-changing consequences, it is imperative that a strict chain of custody procedure is used and that movement and handling of the specimen is documented from start to finish. The documentation should account for the collection, transfer, analysis, storage, and disposal of the sample. Procedures must be in place to ensure that there is no tampering of the specimen and that the specimen has no opportunity to be confused with any other specimen. Proper adherence to the established “Chain of Custody” procedures help solidify the legality of results received from tests conducted using chain of custody protocols.
Clinical Laboratory Improvement Amendments (CLIA): Federal regulatory standards, introduced in 1988, that are applicable to all human clinical lab tests performed in the US. CLIA, however, does not apply to clinical trials and research.
CLIA Waived: Simple procedures with a low risk of error that are not subject to CLIA standards. CLIA waived tests can allow for more rapidly processed results, portability of tests (including some non-traditional test sites), and requires a lower training standard for the technicians conducting the tests.
Clinic: An outpatient healthcare facility offering ambulatory medical treatment, testing, and advice.
Collection Container: Container provided for the purpose of holding a variety of specimens, including urine, blood, hair, oral fluids, and other body samples.
Collection Site: A site that is deemed suitable and that meets all requirements for DOT drug and/or alcohol testing. The site meets all standards as set out by 49 CFR Part 40. Collection sites are usually located at physicians’ offices or clinics, local hospitals, or commercial collection sites; however, it is possible to establish a collection site on the employer’s premises if it meets all requirements set out by 49 CFR Part 40.
Collector: A trained and qualified employee at the collection site that assists and instructs employees with the collection and shipping of samples. The collector is in charge of maintaining the integrity of the specimen between collection and the test itself using chain of custody protocols.
CPC (Certified Professional Collector): CPC is a designation invented by the Drug and Alcohol Testing Industry Association (DATIA). It signifies to the public and employers who would use a collector’s services that the collector has been trained in accordance with DATIA’s standards for collection under federal protocols. CPCs must be trained by a CPC-T (Certified Professional Collector Trainer) or a Regional Certified Professional Collector Trainer (R-CPCT).
CPC-T: An individual who meets DATIA’s requirements for training Certified Professional Collectors, but is approved by DATIA to only conduct training and award CPC designations to those collectors within the CPC-T’s organization.
R-CPCT: An individual who meets DATIA’s requirements for training Certified Professional Collectors and is approved by DATIA to conduct training and award CPC designations to those collectors within the R-CPCT’s organization and to collectors outside of the organization, but is not allowed to award CPC-T designations. CPC-T designations can only be earned from a DATIA-sponsored training events.
Confirmation Test: Also known as “definitive testing,” a confirmation test provides additional drug/alcohol analysis that is conducted in an effort to provide definitive or confirmatory results on a presumptive-positive drug or alcohol screen. The confirmation test is also sometimes utilized to check for drugs that were not tested in the initial screening or to confirm negative results (however, confirming negative results is either allowed or required only in a minority of jurisdictions). Confirmation tests are far more sensitive than drug screens (meaning they will generally have a lower cut-off level) and can test for much specific quantitative concentration information; however, they typically take much longer and cost significantly more than initial drug screens.
Confirmation Validity Test: According to 10 CFR 26.5 [Title 10 – Energy; Chapter I — Nuclear Regulatory Commission; Part 26 — Fitness For Duty Programs; Subpart A — Administrative Provisions], the term confirmatory validity test means “a second test performed on a different aliquot of the original urine specimen to further support a validity test result.” In other words, a confirmation validity test “confirms” that the initial specimen validity test was accurate.
Consortium/Third Party Administrator (C/TPA): A service agent, typically an agency, hired to manage a portion of a company’s DOT and/or Non-DOT drug and alcohol testing program. The C/TPA may oversee the implementation of the employer’s drug testing program while providing advice and assistance with drug and alcohol testing regulatory compliance. The C/TPA may also implement testing procedures and maintain test results in accordance with all current rules and policies. However, the employer cannot discharge regulatory liability and is ultimately responsible for any responsibilities delegated to a C/TPA.
Continuing Education: Courses offered to adults, usually in a particular field of interest. These courses are often required by employers in order for employees to maintain current knowledge of any new or changing industry standards and requirements. After completion of a course, employees are usually given credit for the course in CEUs (continuing education units.) Many companies require an employee to take a minimum number of CEUs per year. Some drug and alcohol testing courses may qualify for continuing education credits for professions such as human resources and nursing.
Control Line: When utilizing an enzymatic drug screening device such as a Point of Collection Test (POCT), the control line validates that the test is working properly. If it appears, then the test is said to be valid, if it does not appear, then the test is considered invalid and a new test must be conducted using a new device.
Correctable Flaw: Flaws in the drug or alcohol testing procedure that can be corrected without having to cancel or invalidate a test. However, if they go uncorrected they will result in a canceled test. Corrections must be made by the end of the same business day. Some issues that would be considered correctable flaws are: an omitted signature on the drug testing form or not marking the temperature of the specimen on the form.
Covered Employee: DOT employees that are considered to have safety-sensitive jobs. These employees are subject to drug and alcohol testing, as outlined in 49 CFR Part 40. Covered employees must not report for duty while having a blood alcohol concentration (BAC) of 0.04% or greater. The Omnibus Transportation Employee Testing Act of 1991 requires that employees who perform safety-sensitive jobs in the aviation, motor carrier, railroad, and mass transit industries be tested for the misuse of drugs and alcohol. Currently,DOT covered employees work with companies regulated by the FMCSA, FAA, FRA, FTA, PHMSA, and the USCG.
Creatine: Creatine is an amino acid produced by the liver, kidneys, and pancreas, though it can also be made synthetically and is sometimes taken orally to improve athletic performance. It supplies energy for muscle contraction and is absorbed through foods like red meat and seafood. When testing a urine specimen for validity, the concentration of creatinine in the sample can indicate that a sample is not real human urine or that the specimen is diluted human urine.
Cutoff Level: The cutoff level is the number that is predetermined to be the threshold between “presumptive-positive” and negative on drug and alcohol screens; the number varies based on the substance being tested. Anything at or above the cutoff level is considered a presumptive-positive test. The cut-off level for the initial screen is often a higher threshold than the number for the confirmation test.
Drug and Alcohol-Free Workplace Policy (DAFWP): A policy set forth by a company in order to protect all employees’ safety and ensure minimum risk in the work environment. In an effort to maintain this environment, an employer will provide education about drug and alcohol abuse and will also conduct drug screens for a variety of reasons in order to maintain a workplace that is free from drug and alcohol misuse.
Drug and Alcohol Testing Industry Association (DATIA): DATIA is an organization that provides education, resources, and advocacy to anyone involved in drug and alcohol testing. They strive to maintain consistency throughout the drug testing community, maintain industry standards, and assist in resolving common problems affecting the drug screening/testing community. To accomplish these goals, DATIA lobbies political representatives and works as an advisor to lawmakers proposing changes to drug and alcohol testing laws and regulations.
Designated Employer Representative (DER): As defined in 49 CFR Part 40, the Designated Employer Representative (DER) is an employee authorized by the employer (sometimes the owner of the company) to make required decisions in the drug and alcohol testing and evaluation processes such as taking immediate action to remove employees from safety-sensitive duties and maintaining testing records. The DER cannot be a service agent. The DER is responsible for maintaining all 49 CFR part 40 regulations and for administering the drug and alcohol program within the workplace. This includes receiving all test results and taking prompt action on any positive test result or refusal determination.
Detection Period: Sometimes referred to as the “window of detection,” the detection period is the amount of time that a drug will remain detectable in a specimen at or above the cutoff level. There is a period of time immediately before and immediately after the detection period in which a substance’s metabolites may be present in a sample, but would be undetected because the concentration would be below the cutoff level. The amount used, frequency of use, and nature of the drug itself often affects the amount of time that a substance remains detectable in a specimen.
Department of Transportation (DOT): Established in October 1966 by Congress, the mission of the DOT is “to serve the United States by ensuring a fast, safe, efficient, accessible, and convenient transportation system that meets our vital national interests and enhances the quality of life of the American people, today and into the future.”
DOT drug and alcohol testing applies to employees who will be working with an employer regulated by the Department of Transportation in a safety-sensitive function as part of their job. DOT drug and alcohol testing regulations are detailed in the federal register under what is known as the “49 CFR Part 40.” This means that DOT testing falls under federal (not state) rules for drug testing. Though they are stringent in what they do test for, they don’t necessarily test for an expansive range of illegal substances. Most DOT tests screen for five major drug groups: cocaine, marijuana, opiates (including four semi-synthetic opioids), PCP, and amphetamines/methamphetamines. These are the drugs tested for under the Department of Transportation (DOT) mandated testing regulations and have become an industry standard as a general minimum adopted by many state drug testing programs. The procedure for collecting a urine, breath, or saliva specimen as outlined in 49 CFR Part 40 is thorough and must be strictly followed whenever a DOT-required specimen collection or test is performed. These procedures apply only to DOT-required testing, but are sometimes adopted by individual state law or company policy.
Drug Metabolites: A metabolite is a byproduct of the metabolization process, which is when the body breaks down and subsequently absorbs a substance when it enters the body. The chemical composition and structure of a drug and its resulting metabolite are almost always distinct–this is why drug tests screen for metabolites rather than the original substances.
Error Correction Training: If a collector, breath alcohol technician, or screening test technician makes a mistake in the testing process that causes a drug or alcohol test to be cancelled, the collector would then be required to undergo error correction training. The training would be specific to the area in which the error occurred followed by three proficiency demonstrations: one uneventful and two specific to the cause of the canceled test.
Ethyl Glucuronide (EtG): The EtG test is a commonly used biomarker screening that detects the presence of ethyl glucuronide in urine samples as well as in blood, hair and nails. The test measures short-term alcohol use and is used to document required alcohol abstinence. An Etg test can produce positive results from exposure to certain household products such as aftershave, mouthwash, breath sprays, and cleaning products. It is currently not an accepted testing modality for most workplace testing.
ETS: ETS is a biomarker of ethanol in addition to EtG. Measured conjointly with EtG, the detection of both biomarkers lends more validity and offers greater accuracy to the test results, indicating a lack of alcohol abstinence.
Federal Aviation Administration (FAA): A division of the US Department of Transportation, the FAA is responsible for overseeing and maintaining the safety, rules, and regulations of civil aviation and the National Airspace System in the U.S. The agency was first created by the Federal Aviation Act in 1958 and was known under that name until 1967 when, after the formation of the DOT, Congress changed the agency’s name to the Federal Aviation Administration. Employees covered by the 49 CFR Part 40 as “safety-sensitive” include pilots, flight crew, certain ground crew, and air traffic controllers.
Fatal Flaw: An error in the drug testing process that cannot be corrected and results in the test being cancelled. Fatal flaws usually result from improper handling and/or labeling of specimens. Fatal flaws include issues such as broken or missing seals, egregiously incomplete paperwork, an ID number that does not match the chain of custody paperwork, or concerns with the chain of custody itself.
Federal Motor Carrier Safety Administration (FMCSA): The Motor Carrier Safety Improvement Act of 1999 created the Federal Motor Carrier Safety Administration (FMCSA) on January 1, 2000. The primary goal of FMCSA is to reduce crashes, injuries, and fatalities involving large trucks and buses. In carrying out its safety mandate to reduce crashes, injuries, and fatalities involving large trucks and buses, FMCSA:
- Develops and enforces regulations that balance motor carrier (truck and bus companies) safety with efficiency;
- Harnesses safety information systems to focus on higher risk carriers in enforcing the safety regulations;
- Targets educational messages to carriers, commercial drivers, and the public; and
- Partners with stakeholders including Federal, State, and local enforcement agencies, the motor carrier industry, safety groups, and organized labor on efforts to reduce bus and truck-related crashes.
Federal Railroad Administration (FRA): The FRA is an agency within the DOT and was created as part of the DOT Act of 1966. The primary purpose of the FRA is to create and enforce rail safety and regulations, oversee railroad assistance programs, research and develop improved railroad safety, develop a comprehensive plan for improving the Northeast Corridor (NEC), and consolidate government support of rail transportation.
Federal Transit Administration (FTA): The FTA is an agency within the DOT. The FTA provides financial and technical assistance to local public transit systems, including buses, subways, light rail, commuter rail, trolleys and ferries. FTA also oversees safety measures and helps research and develop new technology in the field of transit. According to the FTA website, they have partnered with state and local governments since 1964 to create and enhance public transportation systems, investing more than $12 billion annually to support and expand public rail, bus, trolley, ferry and other transit services. The FTA is headed by an administrator appointed by the President of the United States. FTA is one of DOT’s 10 modes of transportation. Its headquarters are located in Washington, D.C. as well as 10 regional offices that assist transit agencies throughout all 50 states and U.S. territories.
Gas Chromatography/Mass Spectrometry (GC/MS): A mode of quantitative testing used to determine the concentration of specified chemical compounds such as ethanol (alcohol) or drug metabolites in a specimen. This type of testing is most often used for confirmation testing rather than screening.
Health and Human Services (HHS): According to their website, it is the mission of the U.S. Department of Health & Human Services (HHS) to enhance and protect the health and well-being of all Americans. We (HHS) fulfill that mission by providing for effective health and human services and fostering advances in medicine, public health, and social services. In addition to maintaining a list of certified laboratories under SAMHSA, HHS regulations cover certain federally-regulated employees not covered under DOT regulations. These regulations are substantially similar to DOT regulations, but do involve some important distinctions such as requiring an observer to have been trained prior to a collection conducted under direct observation.
Immunoassay: Immunoassay tests use antibodies to detect the presence of drugs and their metabolites in blood and other body fluids. These tests are the preferred initial screening tests because they can be processed quickly and are inexpensive. The most commonly ordered drug screens are for cocaine metabolites, amphetamines, phencyclidine, marijuana metabolites, and opiate metabolites. Immunoassays are based on the principles that specific antigens will stimulate highly specific immune responses and that the proteins (antibodies) produced by that immune response can be used to signal the presence of a target compound in a specimen.
Initial Drug Screen: This is the initial phase of drug testing. During the initial screen, tests are conducted to determine whether the sample is potentially positive. If a sample is found to have a presumptive positive result during this phase, the initial drug test will undergo a second round of testing to confirm the presence of drugs or drug metabolites in the sample.
Instrumental Initial Testing Facility (IITF): Under HHS drug testing protocols, SAMHSA is authorized to certify a facility as an intermediary facility capable of receiving specimens under HHS protocols. The DOT regulations prohibit the use of an IITF.
Initial Validity Test: An initial validity test is the first attempt to determine if a specimen has been adulterated, substituted, or diluted. If the specimen fails the initial validity test a second validity test will be conducted, known as a confirmation validity test. If the confirmation validity test indicates the sample is invalid, the sample is deemed unacceptable for drug testing. The sample may have abnormal physical characteristics, abnormal levels in properties of the urine, or unknown substances present that would prohibit the testing from being conducted.
Instant Test Kit: Drug testing kits that can be used at a remote location, workplace, or a collection site. The test results are delivered rapidly and can save employers time and money. Instant or on-site drug testing is not allowed for DOT regulated drug testing and is also prohibited in many states for non-federal or Non-DOT testing.
Invalid Drug Test: Refers to the laboratory results for a urine or bodily fluid sample that contains an unidentified adulterant, contains an unidentified interfering substance, has an abnormal physical characteristic, or contains a substance at an abnormal concentration that prevents the laboratory from completing the testing. An invalid test is considered neither positive or negative. In the case of an invalid result, the MRO (medical review officer) would interview the donor to try and determine if there is a credible explanation for the invalid results. 49 CFR 40 provides guidance on what to do in the event of an invalid drug test under DOT protocols.
Laboratory: In drug testing, the laboratory is responsible for completing the chain of custody protocols by receiving a specimen, inspecting and documenting its condition, verifying its integrity, and then testing the specimen for the presence of drugs and their metabolites. In Non-DOT testing, any laboratory the state deems qualified to test may conduct drug tests on samples submitted for workplace testing. However, only drug testing laboratories or IITFs certified by SAMHSA, a division of the Department of Health and Human Services, may receive urine specimens and test them to determine the presence of drugs under federal protocols for covered employees. SAMHSA-Certified laboratories also conduct validity testing to determine if the specimen has been adulterated or substituted. US laboratories are only permitted to participate in DOT drug testing if they are certified by HHS under the National Laboratory Certification Program (NLCP) or in the case of a foreign laboratory, if it is approved for participation by the DOT with respect to Part 40.
Liquid Chromatography–Mass Spectrometry (LC-MS): LC-MS is a highly sensitive analytical chemistry technique that combines the physical separation capabilities of liquid chromatography (or HPLC) with the mass analysis capabilities of mass spectrometry (MS). Following a positive immunoassay or broad spectrum drug screen, it is widely used in confirmatory toxicology testing and is used to identify a wide range of drugs and their metabolites. LC-MS is commonly used in the field of bioanalysis and is particularly applicable in pharmacokinetic studies of pharmaceuticals. Pharmacokinetic studies can determine how quickly a drug will be cleared from the body.
Liquid Chromatography with Tandem Mass Spectrometry (LC-MS/MS): LC/MS/MS is a confirmatory technique that allows for the detection of a wide range of compounds at lower concentrations than other techniques. Unlike point of care urine cups or immunoassay screening techniques, the LC-MS/MS allows for identification of a specific compound. Liquid chromatography with tandem mass spectrometry is a powerful analytical technique that combines the unique separating power of liquid chromatography with the highly sensitive and selective mass analysis capability of triple quadrupole mass spectrometry, providing optimum levels of sensitivity and accuracy.
Limit of Detection (LOD): The Limit of Detection is an estimate of the minimum amount of a substance that an analytical process can reliably detect. The LOD is the smallest amount or concentration of a particular substance that must be present in a sample in order to be detected at a 99% level of confidence. Accrediting organizations require laboratories to identify the LOD of a method as part of the method or instrument certification process. This is not to be confused with a device’s cut-off level, which will always be higher than any testing method’s “LOD.”
Monitored Collection: Monitored collections occur when the collection takes place in a multi-stall restroom facility. The collector goes into the restroom with the donor, but the donor enters the stall alone and is allowed to close the door. It is preferred that the collector be the same sex as the donor, but it is not required if the collector is classified as a medical professional. Monitored collections allow the collector to only have to secure one stall in the multi-stall facility rather than securing every individual stall and sink in the multi-stall facility.
Medical Review Officer (MRO): A Medical Review Officer (MRO) is a licensed physician who is responsible for receiving and reviewing laboratory results from an employer’s drug testing program. An MRO acts as an independent and neutral advocate for the accuracy and integrity of the drug testing process. They provide quality assurance review of the drug testing process for the specimens under their watch, determine if there is a legitimate medical explanation for laboratory confirmed positive, adulterated, substituted and invalid drug test results, ensure the timely release of test results to employers, and protect the confidentiality of the information in their care.
Negative result: A negative test result means that the concentrations in the blood or fluid sample are below the designated cut-off levels for the particular substance that was tested. A negative drug test result does not always mean there are no drugs present in the person being tested; it just indicates that there are not drugs present above the cut-off level. Some laboratories allow drug tests to be conducted on samples on their LOD rather than their cutoff levels to report lower concentrations than cut-off levels.
National Institute for Drug Abuse (NIDA): According to their website, the mission of NIDA is “to advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health. This involves strategically supporting and conducting basic and clinical research on drug use (including nicotine), its consequences, and the underlying neurobiological, behavioral, and social mechanisms involved. It also involves ensuring the effective translation, implementation, and dissemination of scientific research findings to improve the prevention and treatment of substance use disorders and enhance public awareness of addiction as a brain disorder.”
Non-DOT Drug Testing: Non-DOT drug testing is a catch-all term for testing conducted under local jurisdiction-specific protocols rather than federal protocols. A Non-DOT drug test can consist of a 5 drug panel like DOT or be expanded to as many panels as the state or local jurisdiction will allow. Non-DOT employers can also often choose to test for hallucinogens, anabolic steroids, prescription painkillers and ecstasy. Non-regulated drug testing gives employers the freedom to choose the type of specimen they want to test (urine, hair saliva, blood) and to develop a drug testing program without the strict requirements of the federal government. It is common for companies and organizations with employees not regulated by federal protocols to choose to adopt 49 CFR Part 40 procedures for their own Non-DOT drug and alcohol testing programs, but then elect to expand upon federal regulations in order to include testing for a wider variety of drugs or to include instant testing as allowed by the local jurisdiction.
Non-Negative Specimen: This term is almost exclusively utilized in instant or rapid testing under Non-DOT protocols. It refers to a drug screening with a presumptive-positive result which must then be sent to a laboratory for confirmation.
Nuclear Regulatory Commission (NRC): According to their website, the U.S. Nuclear Regulatory Commission (NRC) was “created as an independent agency by Congress in 1974 to ensure the safe use of radioactive materials for beneficial civilian purposes while protecting people and the environment. The NRC regulates commercial nuclear power plants and other uses of nuclear materials, such as in nuclear medicine, through licensing, inspection and enforcement of its requirements.” The NRC as a federal agency maintains its own set of protocols for drug and alcohol testing for employees regulated by the NRC in safety-sensitive functions.
Observed Collection: A directly observed collection procedure is the same as a routine collection procedure with the additional requirement that an observer personally observe the urine go from the employee’s body into the collection container after inspecting the individual for anything they could possibly use to manipulate the collection. The observer must be the same gender as the employee and there are no exceptions to this requirement. An observed collection may be warranted for one of several reasons: (1) an MRO reported that a result was invalid for no explainable reason; (2) the original positive, adulterated, or substituted result had to be cancelled because the test of the split specimen could not be performed; (3) the specimen was reported as a negative dilute; (4) the collector determined that the first specimen provided during a collection may have been adulterated or substituted; or (5)the test is a return-to-duty or follow-up test. If the observer is not the collector, the observer does not handle the specimen, but maintains constant eye contact with the specimen as it is delivered to the collector by the employee. Due to concerns over privacy, some states prohibit the use of an observed collection unless conducting a DOT collection.
Office of Drug and Alcohol Policy and Compliance (ODAPC): According to their website, the Office of Drug and Alcohol Policy and Compliance “advises the Secretary [of Transportation] on national and international drug testing and control issues and is the principal advisor to the Secretary on rules related to the drug and alcohol testing of safety-sensitive transportation employees in aviation, trucking, railroads, mass transit, pipelines, and other transportation industries. The Office publishes regulations and provides official interpretations on drug and alcohol testing, including how to conduct tests, and the evaluation and treatment procedures necessary for returning employees to duty after testing violations.” ODAPC is an important resource for all DOT service agents as they provide guidance and interpretations of DOT regulations as they pertain to the 49 CFR Part 40.
Opiate: Opioids are a class of drugs that include the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®), hydrocodone (Vicodin®), codeine, morphine, and many others.
According to the NIDA website, “All opioids are chemically related and interact with opioid receptors on nerve cells in the body and brain. Opioid pain relievers are generally safe when taken for a short time and as prescribed by a doctor, but because they produce euphoria in addition to pain relief, they can be misused (taken in a different way or in a larger quantity than prescribed, or taken without a doctor’s prescription). Regular use—even as prescribed by a doctor—can lead to dependence and, when misused, opioid pain relievers can lead to addiction, overdose incidents, and deaths.”
Occupational Safety and Health Administration (OSHA): With the Occupational Safety and Health Act of 1970, Congress created the Occupational Safety and Health Administration (OSHA) under the US Department of Labor to ensure safe and healthy working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education and assistance.
In post-accident testing, businesses that operate under OSHA regulations must show that there is a reasonable basis or suspicion that drug or alcohol use caused or contributed to the reported injury or illness to justify requiring the employee to submit to a drug and/or alcohol test.
Panel: Panel drug tests are designed to screen for multiple types of drugs from only one sample, making the process more expeditious and cost-efficient. A standard 5-panel drug urine test is the drug test most frequently used by government agencies and private employers. A 5-panel drug test typically tests for commonly abused substances, including THC, Opiates, PCP, Cocaine, and Amphetamines. The Department of Transportation also uses five-panel urine drug tests. A non-DOT drug test can consist of a 5 drug panel or be expanded to a 10-panel or greater. The 5-panel typically tests for marijuana, cocaine, opiates, amphetamines/methamphetamines, and phencyclidine (PCP). A 10-panel drug test would generally include the standard 5-panel and add barbiturates, benzodiazepines, methadone, methaqualone, and propoxyphene to the list. Non-DOT employers can also choose to test for hallucinogens, anabolic steroids, prescription painkillers and ecstasy. Non-regulated drug testing gives employers the ability to choose the type of specimen they want to test (urine, hair saliva, blood) and to develop a drug testing program without the stricter requirements of the federal government.
Phencyclidine (PCP): PCP (also known as “angel dust”) appeared on the market in the 1950s as an anesthetic and tranquilizer known as Sernyl, but was discontinued in 1967. PCP is a Schedule II Controlled Substance; it is an illegal psychedelic drug that induces hallucinations and produces a feeling of detachment from oneself and one’s surroundings. Phencyclidine is considered extremely dangerous, and its use has been linked to violent and aggressive behaviors, psychosis, and a heightened risk of accidental death. An overdose can be fatal. PCP is a standard part of the DOT 5-panel drug test.
PHMSA: PHMSA’s mission is to protect people and the environment by advancing the safe transportation of energy and other hazardous materials that are essential to the public. To do this, the agency establishes national policy, sets and enforces standards, educates, and conducts research to prevent incidents. They also educate and train the public and first responders to reduce consequences if an incident does occur.
As an agency under the US DOT, PHMSA conducts drug testing under 49 CFR Part 199 (PHMSA drug and alcohol testing regulations) and 49 CFR Part 40 (DOT drug and alcohol testing regulations).
Point of Care Testing (POCT): Point of Care Testing, sometimes called “Point of Collection Testing” (POCT) in drug testing is defined as testing performed outside of a clinical laboratory in close proximity to where the collection takes place. POCT is typically performed by trained Non-DOT collectors rather non-laboratory personnel.
DOT regulations do not allow the use of POCT or instant drug test kits for DOT covered employees.
Positive Test Result: A specimen is reported as positive if it meets or exceeds a pre-established cutoff level and has undergone additional laboratory testing (known as confirmation testing) after the initial preliminary positive test results were received.
Under DOT policy, an employer or supervisor who receives a verified positive drug test result must immediately remove the employee involved from performing safety-sensitive functions. The supervisor must take this action swiftly upon receiving the initial report of the verified positive test result and should not wait to receive the written report or the result of a split specimen test.
Preliminary (or Presumptive) Positive Drug Testing Result: If, after an initial drug and/or alcohol screening, the screening test produced a “positive” result, the results would be considered a preliminary or presumptive positive test. In instant testing, the preferred term is a “non-negative” result. The initial screening is a preliminary test and is the first step in a two-step process. If a screen is found to be preliminary positive, it then undergoes additional confirmatory laboratory tests to verify the results.
Primary Specimen: As it relates to drug testing, the primary specimen is the urine specimen bottle that is collected, opened, and tested first by a laboratory to determine if the employee has a drug or drug metabolite in his or her system. In DOT testing, this bottle should contain 30 milliliters. A second bottle may be collected and tested at a later time; this would be referred to as a “split specimen” (the DOT requires a split specimen collection for every test).
Qualification Training: Training requirements to be a DOT specimen collector are outlined in 49 CFR Part 40.33. Qualification training is the second step in Urine Specimen Collection training, Breath Alcohol Technician Training, or Screening Test Technician Training following the basic information training requirement. In qualification training, the collector is trained on appropriate steps during the collection process, how to properly handle specimens, and how to handle flaws or errors in the testing process. To complete the training, the student must complete a proficiency demonstration, in which the collector would conduct error-free mock collections. The training is valid for five years.
Refresher Training: Training that must be completed in order to renew a training qualification for specimen collection or testing. Under DOT protocols refresher training must be completed by the collector or technician within five years of the date she completed her original training or latest refresher training course. The training must continue to be renewed every five years.
Safety-Sensitive Position: According to the DOT website, safety-sensitive positions include positions such as pilots, truck drivers, subway operators, ship captains, pipeline controllers, airline mechanics, locomotive engineers, and bus drivers. It is essential that these transportation workers be as clear-headed and as alert as possible at all times. Use of illegal drugs and misuse of alcohol are not compatible with performing these crucial functions. To protect the interests of the public, in 1991 Congress passed the Omnibus Transportation Employees Testing Act that requires DOT Agencies to conduct drug and alcohol testing on safety-sensitive transportation workers.
The Substance Abuse and Mental Health Services Administration (SAMHSA): According to their website, “SAMHSA is the agency within the U.S. Department of Health and Human Services that leads public health efforts to advance the behavioral health of the nation. SAMHSA’s mission is to reduce the impact of substance abuse and mental illness on America’s communities.”
The Substance Abuse and Mental Health Services Administration Guidelines indicate that certain federally-regulated businesses that employ individuals with safety-sensitive jobs, should have a drug testing system in place along with a procedure to refer employees who test positive to a Substance Abuse Professional (SAP).
Substance Abuse Professional (SAP): According to the DOT website, “A SAP is a person who evaluates employees who have violated a DOT drug and alcohol program regulation and makes recommendations concerning education, treatment, follow-up testing, and aftercare.”
A SAP is neutral and is an advocate for neither the employer nor the employee. Their job is to protect the public interest in safety by carefully evaluating the employee and recommending appropriate actions.
Screening: The initial process of testing the breath, blood, urine, saliva or hair for different substances. In most, but not all cases, a negative screen does not require any follow-up; however, if a drug screen has a non-negative result, further confirmation testing is required. Confirmatory tests can provide more precise data and rule out errant results. The DOT uses only urine to screen for drugs and breath and saliva tests to screen for alcohol.
Service Agent: A service agent is a person or entity used to help implement the DOT drug and alcohol testing procedures and regulations. This may include a breath alcohol technician, a screening test technician, a urine collector, a laboratory, a medical review officer, a substance abuse professional, or a consortium/third-party administrator in charge of coordinating the employer’s drug and alcohol testing services. Service agents may be used to administer a portion of an employer’s DOT drug and alcohol testing program, but cannot make essential determinations such as hiring and firing decisions and certain refusal determinations. The requirements for a service agent are defined by 49 CFR Part 40.
Shipping container: A container designed to secure the specimens and adequately protect the specimen bottles from shipment damage in the transport of specimens from the collection site to the laboratory (e.g., standard courier box, small cardboard box, plastic container).
Specific Gravity (SG): SG is a measurement of the density of a liquid compared to the density of water, and it measures the concentration of dissolved particles in a sample. While there are a number of acceptable medical explanations for a low specific gravity, it can also indicate that a sample may have been tampered with. Specific gravity may indicate that there is too much water in the urine to obtain an accurate measurement of what is actually contained in the urine. If the levels are too far outside of the normal range, the specimen may be reported as diluted or adulterated.
Specimen Container: According to the DOT website, a specimen container is an individually wrapped, single-use plastic container, and is large enough to easily catch and hold at least 55 milliliters of urine voided from the body. It must also contain a temperature strip that is affixed at the proper level.
Split Specimen: A split specimen collection occurs when the employee’s urine sample is split between two specimen cups (Bottle A and Bottle B) in order to have a second sample tested at the employee’s discretion following a positive or dilute result. Split specimen collections are required under DOT regulations and are required or recommended under Non-DOT protocols.
Stand Down: “Stand-down” refers to the employer practice of temporarily removing an employee from the performance of safety-sensitive duties after learning that the individual had a confirmed laboratory positive drug test, but before the MRO has completed the verification process. An employer may, however, seek DOT operating authority approval for a specific, written stand-down plan that permits a “stand down,” but simultaneously protects the interests of employees. The practice of “stand-down” is prohibited unless a waiver is granted by DOT.
Substituted Specimen: When a urine specimen fails to meet the creatinine and specific gravity values necessary to demonstrate that it is a normal human urine specimen it is identified as a substituted specimen under the U.S. Department of Transportation’s provisions for drug and alcohol testing.
Temperature Strip: A temperature strip can be placed on the outside of a urine specimen container/cup in order to validate the specimen’s temperature. The temperature should be read within 4 minutes and should read between 90 and 100 degrees fahrenheit; specimens with a reading outside this range may be suspected of adulteration, substitution, or dilution. All DOT urine specimen collection containers are required to have a temperature strip.
Tetrahydrocannabinol (THC): THC is the primary psychoactive ingredient in the cannabis sativa plant. It is manufactured for use pharmaceutically under the name Dronabinol and packaged under common names like Marinol and Syndros used to treat symptoms of cancer treatment and AIDS. THC is listed as a Schedule I Substance under US federal law, and as such, DOT regulation 49 CFR Part 40 does not currently authorize (as of September, 2018) even prescription THC to be a valid medical explanation for a covered employee’s positive drug test result.
United States Coast Guard (USCG): The USCG is currently regulated by Homeland Security. Employers regulated by the Coast Guard must follow DOT 49 CFR Part 40 regulations in order to maintain a drug and alcohol free workplace. They still follow these DOT regulations as part of an agreement between the Department of Homeland Security and the Department of Transportation.
Anyone applying for a Captain’s license or other merchant mariner credential needs an initial drug test and periodic drug testing every two years. Only a DOT 5 Panel (SAMHSA 5) will be accepted, and the laboratory used must be accredited by the Substance Abuse and Mental Health Services Administration (SAMHSA), and the final drug test results must be signed by a Certified Medical Review Officer (MRO).
Verified Laboratory Test: A confirmed drug test result or validity testing result from an HHS-certified laboratory that has undergone review and final determination by the MRO.
Void: To urinate. All DOT drug screen specimens are obtained from the employee by voiding into a plastic specimen container as outlined by 49 CFR Part 40.
World Health Organization (WHO): According to their website, the WHO is a “directing and coordinating authority on international health within the United Nations’ system.” The WHO achieves this by:
- “providing leadership on matters critical to health and engaging in partnerships where joint action is needed;
- shaping the research agenda and stimulating the generation, translation and dissemination of valuable knowledge;
- setting norms and standards and promoting and monitoring their implementation;
- articulating ethical and evidence-based policy options;
- providing technical support, catalysing change, and building sustainable institutional capacity; and
- monitoring the health situation and assessing health trends.”
According to the WHO website, their Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) is ”a questionnaire that screens for all levels of problem or risky substance use in adults. The ASSIST (V3.1 or V3.0) consists of eight questions covering tobacco, alcohol, cannabis, cocaine, amphetamine-type stimulants (including ecstasy) inhalants, sedatives, hallucinogens, opioids and ‘other drugs’. A risk score is provided for each substance, and scores are grouped into ‘low risk’, ‘moderate risk’ or ‘high risk’. The risk score determines the level of intervention recommended (‘treatment as usual’, ‘brief intervention’ or ‘brief intervention plus referral to specialist treatment’).”
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