If an employee requests his/her records from the MRO, do these records include the MRO`s notes and comments or only copies of the CCF and laboratory result?
- In general, the MRO should provide all records that are available related to that employee, to include written notes, checklists, or comments. All of this information was obtained from the employee or from appropriate individuals or organizations (with the employee`s authorization) or from documentation provided by the employee.
- Consistent with appropriate medical record constraints, the MRO may need to withhold or interpret sensitive medical, psychiatric, and mental health record information.
May the previous employer delay sending an employee`s drug and alcohol testing information to the gaining employer pending payment for the cost of the information?
No. Part 40 specifically requires that previous employers immediately provide the gaining employer with the appropriate drug and alcohol testing information.
No one (i.e., previous employer, service agent [to include C/TPA], employer information / data broker) may withhold this information from the requesting employer pending payment for it.
- If “Invalid – Color difference” is the only result reported to you, you must follow the guidance of §40.159 by contacting the laboratory to obtain more specific information about the color difference between the specimens, and contacting the donor to obtain a legitimate explanation for the color difference. While there is no legitimate medical reason for anyone being able to provide a specimen that separates into two different colors when placed in two different bottles, the interview is necessary to determine appropriate follow-on action.
- You must determine whether the donor has provided you with a legitimate explanation for the color difference (e.g., the collector used two separate voids for the collection), or not (e.g., no clue as to how the colors changed by the time the specimens reached the laboratory).
- You must follow §40.159 for canceling the result, reporting the result to the employer, determining whether a recollection is necessary and, if so, should it be under direct observation.
- If the laboratory has also reported to you that the specimen is positive, adulterated, or substituted, then you must process the results in accordance with §40.1129-131. If you determine (i.e., verifiy) the final result to be positive, adulterated, or substituted, then no additional action is required by you due to the color difference. You must not direct the employee to take another test.
- Notify the employer that the collector must receive “error correction training” as required by §40.33(f). The area of Part 40 in which the collector needs to be retrained is §40.65(a).
Will FMCSA- and FAA-regulated employers complying with the drug and alcohol information records check requirements contained in the Federal Motor Carrier Safety Administration (FMCSA) regulation 49 CFR Part 391 and the Federal Aviation Administration (FAA) Pilot Record Improvement Act be considered compliant with 40.25?
- Yes. Employers who are required by and who comply with the FMCSA`s three-year requirement for obtaining and providing employee drug and alcohol testing information are considered to have satisfied the two-year requirement contained in 40.25.
- Likewise, employers who are required by and who comply with the FAA`s five-year requirement for obtaining and providing employee drug and alcohol testing information are considered to have satisfied the two-year requirement contained in 40.25.
- These employers do not need to seek separately the 40.25 information if the employer adheres to the FMCSA and FAA regulations, as appropriate, for obtaining an employee`s prior drug and alcohol testing information.
Are employers and their service agents in the Department of Transportation (DOT) drug and alcohol testing program required to obtain employee written authorizations in order to disclose drug and alcohol testing information?
• In the DOT drug and alcohol testing program, employers and service agents are not required to obtain written employee authorization to disclose drug and alcohol testing information where disclosing the information is required by 49 CFR Part 40 and other DOT Agency & U.S. Coast Guard (USCG) drug and alcohol testing regulations. 49 CFR Part 40 and DOT Agency & USCG regulations provide for confidentiality of individual test-related information in a variety of other circumstances.
• Even if drug and alcohol testing information is viewed as protected under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) rules, it is not necessary to obtain employee written authorization where DOT requires the use or disclosure of otherwise protected health information under 49 CFR Part 40 or the other DOT Agency & USCG drug and alcohol testing regulations.
• Unless otherwise stipulated by 49 CFR Part 40 or DOT Agency & USCG regulations, use or disclosure of the DOT drug and alcohol testing information without a consent or authorization from the employee is required by the Omnibus Transportation Employees Testing Act of 1991, 49 CFR Part 40, and DOT Agency & USCG drug and alcohol testing regulations.
• Consequently, an employer or service agent in the DOT program may disclose the information without the written authorization from the employee under many circumstances. For example:
— Employers need no written authorizations from employees to conduct DOT tests.
— Collectors need no written authorizations from employees to perform DOT urine collections, to distribute Federal Drug Testing Custody and Control Forms, or to send specimens to laboratories.
— Screening Test Technicians and Breath Alcohol Technicians need no written authorizations from employees to perform DOT saliva or breath alcohol tests (as appropriate), or to report alcohol test results to employers.
— Laboratories need no written authorizations from employees to perform DOT drug and validity testing, or to report test results to Medical Review Officers (MROs).
— MROs need no written authorizations from employees to verify drug test results, to discuss alternative medical explanations with prescribing physicians and issuing pharmacists, to report results to employers, to confer with Substance Abuse Professionals (SAPs) and evaluating physicians, or to report other medical information (see §40.327).
— SAPs need no written authorizations from employees to conduct SAP evaluations, to confer with employers, to confer with MROs, to confer with appropriate education and treatment providers, or to provide SAP reports to employers.
— Consortia/Third Party Administrators need no written authorizations from employees to bill employers for service agent functions that they perform for employers or contract on behalf of employers.
— Evaluating physicians need no written authorizations from employees to report evaluation information and results to MROs or to employers, as appropriate.
— Employers and service agents need no written authorizations from employees to release information to requesting Federal, state, or local safety agencies with regulatory authority over them or employees.
As an employer, or an employer’s service agent—for example a C/TPA, you must ensure the collector has the following information when conducting a urine specimen collection for you:
(a) Full name of the employee being tested.
(b) Employee SSN or ID number.
(c) Laboratory name and address (can be pre-printed on the CCF).
(d) Employer name, address, phone number, and fax number (can be pre-printed on the CCF at Step 1-A).
(e) DER information required at §40.35 of this part.
(f) MRO name, address, phone number, and fax number (can be pre-printed on the CCF at Step 1-B).
(g) The DOT Agency which regulates the employee’s safety-sensitive duties (the checkmark can pre-printed in the appropriate box on the CCF at Step 1-D).
(h) Test reason, as appropriate: Pre-employment; Random; Reasonable Suspicion/Reasonable Cause; Post-Accident; Return-to-Duty; and Follow-up.
(i) Whether the test is to be observed or not (see §40.67 of this part).
(j) (Optional) C/TPA name, address, phone, and fax number (can be pre-printed on the CCF).
Is a Medical Review Officer (MRO) permitted to accept an employee’s prescription for medication obtained over the Internet?
• An MRO is authorized to accept an employee’s prescription for medication obtained over the Internet only if there is proof that a legitimate doctor-patient relationship had been established.
• The following four elements generally serve as an indication that a legitimate doctor-patient relationship has been established:
— A patient has a medical complaint;
— A medical history has been taken;
— A physical examination has been performed; and
— Some logical connection exists between the complaint, the medical history, the physical examination, and the drug prescribed.
• Standing alone, the completion of an online questionnaire reviewed later by a pharmacy-employed doctor fails to establish a proper doctor-patient relationship.
• The MRO should, at a minimum, consider the following items when verifying the test result:
— The name, physical location, and state(s) of licensure of the prescribing practitioner;
— Whether the employee was professionally evaluated for the current medical complaint by the prescribing practitioner, and the last time the employee was in direct contact with the prescribing practitioner;
— Whether the employee initiated the request to the pharmacy for a particular medication; and
— Whether a proper doctor-patient relationship existed.
• It is the employee’s responsibility to provide sufficient documentation to address MRO inquiries as to whether there was a legitimate doctor-patient relationship.
In addition to information needed for billing purposes, does DOT authorize other information to be included outside the boundaries of the Alcohol Testing Form (ATF)?
(a) This part tells all parties who conduct drug and alcohol tests required by Department of Transportation (DOT) agency regulations how to conduct these tests and what procedures to use.
(b) This part concerns the activities of transportation employers, safety-sensitive transportation employees (including self-employed individuals, contractors and volunteers as covered by DOT agency regulations), and service agents.
(c) Nothing in this part is intended to supersede or conflict with the implementation of the Federal Railroad Administration`s post-accident testing program (see 49 CFR 219.200).
During periods of hot weather, how may Medical Review Officers (MROs) handle laboratory results reported as invalid because of pH greater than or equal to 9.0 but less than or equal to 9.5?
• Part 40 requires an MRO to provide an employee the opportunity to present a medical explanation for an invalid test result, to include any related to pH.
— If the employee provides an acceptable medical explanation, the MRO is authorized to cancel the test and take no further action.
— If there is no acceptable medical explanation, the MRO will cancel the test and will notify the employer or Designated Employer Representative (DER) to direct another collection under direct observation.
• The Department is aware of current research and studies offering evidence that, over time, heat may cause the pH to rise, typically into the range of 9.0 through 9.3, but not higher than 9.5. [See, for example, “Urine pH: the Effects of Time and Temperature after Collection,” Journal of Analytical Toxicology, Vol. 31, October 2007.]
• Consequently, when an employee has no other medical explanation for the pH in the 9.0 – 9.5 range, MROs should consider whether there is evidence of elapsed time and increased temperature that could account for the pH value.
• In doing so, MROs are authorized to consider the following:
— The temperature conditions that were likely to have existed between the time of collection and transportation of the specimen to the laboratory; and
— The length of time between the specimen collection and arrival at the laboratory.
• MROs may talk with the collection sites to discuss time and temperature issues, including any pertinent information regarding specimen storage.
• If the MRO determines that time and temperature account for the pH value, the MRO is authorized to cancel the test and take no further action.
• If the MRO determines that time and temperature fail to account for the pH value, the MRO is authorized cancel the test and direct another collection under direct observation.
In this part, the terms listed in this section have the following meanings:
Adulterated specimen. A specimen that has been altered, as evidenced by test results showing either a substance that is not a normal constituent for that type of specimen or showing an abnormal concentration of an endogenous substance.
Affiliate. Persons are affiliates of one another if, directly or indirectly, one controls or has the power to control the other, or a third party controls or has the power to control both. Indicators of control include, but are not limited to: interlocking management or ownership; shared interest among family members; shared facilities or equipment; or common use of employees. Following the issuance of a public interest exclusion, an organization having the same or similar management, ownership, or principal employees as the service agent concerning whom a public interest exclusion is in effect is regarded as an affiliate. This definition is used in connection with the public interest exclusion procedures of Subpart R of this part.
Air blank. In evidential breath testing devices (EBTs) using gas chromatography technology, a reading of the device’s internal standard. In all other EBTs, a reading of ambient air containing no alcohol.
Alcohol. The intoxicating agent in beverage alcohol, ethyl alcohol or other low molecular weight alcohols, including methyl or isopropyl alcohol.
Alcohol concentration. The alcohol in a volume of breath expressed in terms of grams of alcohol per 210 liters of breath as indicated by a breath test under this part.
Alcohol confirmation test. A subsequent test using an EBT, following a screening test with a result of 0.02 or greater, that provides quantitative data about the alcohol concentration.
Alcohol screening device (ASD). A breath or saliva device, other than an EBT, that is approved by the National Highway Traffic Safety Administration (NHTSA) and appears on ODAPC’s Web page for “Approved Screening Devices to Measure Alcohol in Bodily Fluids” because it conforms to the model specifications from NHTSA.
Alcohol screening test. An analytic procedure to determine whether an employee may have a prohibited concentration of alcohol in a breath or saliva specimen.
Alcohol testing site. A place selected by the employer where employees present themselves for the purpose of providing breath or saliva for an alcohol test.
Alcohol use. The drinking or swallowing of any beverage, liquid mixture or preparation (including any medication), containing alcohol.
Aliquot. A fractional part of a specimen used for testing. It is taken as a sample representing the whole specimen.
Breath Alcohol Technician (BAT). A person who instructs and assists employees in the alcohol testing process and operates an evidential breath testing device.
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. The procedure used to document the handling of the urine specimen from the time the employee gives the specimen to the collector until the specimen is destroyed. This procedure uses the Federal Drug Testing Custody and Control Form (CCF) as approved by the Office of Management and Budget.
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 employees present themselves 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.
Confirmatory drug test. A second analytical procedure performed on a different aliquot of the original specimen to identify and quantify the presence of a specific drug or drug metabolite.
Confirmatory validity test. A second test performed on a different aliquot of the original 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. This term includes, but is not limited to, groups of employers who join together to administer, as a single entity, the DOT drug and alcohol testing programs of its members. C/TPAs are not “employers” for purposes of this part.
Continuing education. Training for substance abuse professionals (SAPs) who have completed qualification training and are performing SAP functions, designed to keep SAPs current on changes and developments in the DOT drug and alcohol testing program.
Designated employer representative (DER). An employee authorized by the employer to take immediate action(s) to remove employees from safety-sensitive duties, or cause employees to be removed from these covered 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 urine specimen with creatinine and specific gravity values that are lower than expected for human urine.
DOT, The Department, DOT Agency. These terms encompass all DOT agencies, including, but not limited to, 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 Pipeline and Hazardous Materials Safety Administration (PHMSA), and the Office of the Secretary (OST). For purposes of this part, the United States Coast Guard (USCG), in the Department of Homeland Security, is considered to be a DOT agency for drug testing purposes only since the USCG regulation does not incorporate Part 40 for its alcohol testing program. These terms include any designee of a DOT agency.
Drugs. The drugs for which tests are required under this part and DOT agency regulations are marijuana, cocaine, amphetamines, phencyclidine (PCP), and opioids.
Employee. Any person who is designated in a DOT agency regulation as subject to drug testing and/or alcohol testing. The term includes individuals currently performing safety-sensitive functions designated in DOT agency regulations and applicants for employment subject to pre-employment testing. For purposes of drug testing under this part, the term employee has the same meaning as the term “donor” as found on CCF and related guidance materials produced by the Department of Health and Human Services.
Employer. A person or entity employing one or more employees (including an individual who is self-employed) subject to DOT agency regulations requiring compliance with this part. The term includes an employer’s officers, representatives, and management personnel. Service agents are not employers for the purposes of this part.
Error Correction Training. Training provided to BATs, collectors, and screening test technicians (STTs) following an error that resulted in the cancellation of a drug or alcohol test. Error correction training must be provided in person or by a means that provides real-time observation and interaction between the instructor and trainee.
Evidential Breath Testing Device (EBT). A device that is approved by the National Highway Traffic Safety Administration (NHTSA) for the evidential testing of breath at the .02 and .04 alcohol concentrations, and appears on ODAPC’s Web page for “Approved Evidential Breath Measurement Devices” because it conforms with the model specifications available from NHTSA.
HHS. The Department of Health and Human Services or any designee of the Secretary, Department of Health and Human Services.
Initial drug test (also known as a “Screening drug test”). The test used to differentiate a negative specimen from one that requires further testing for drugs or drug metabolites.
Initial specimen validity test. The first test used to determine if a urine specimen is adulterated, diluted, substituted, or invalid.
Invalid drug test. The result reported by an HHS-certified laboratory in accordance with the criteria established by HHS Mandatory Guidelines when a positive, negative, adulterated, or substituted result cannot be established for a specific drug or specimen validity test.
Invalid result. The result reported by a laboratory for a urine specimen that contains an unidentified adulterant, contains an unidentified interfering substance, has an abnormal physical characteristic, or has an endogenous substance at an abnormal concentration that prevents the laboratory from completing testing or obtaining a valid drug test result.
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; or, in the case of foreign laboratories, a laboratory approved for participation by DOT under this part.
Limit of Detection (LOD). The lowest concentration at which a measurand can be identified, but (for quantitative assays) the concentration cannot be accurately calculated.
Limit of Quantitation. For quantitative assays, the lowest concentration at which the identity and concentration of the measurand can be accurately established.
Medical Review Officer (MRO). A person who is a licensed physician and who is responsible for receiving and reviewing laboratory results generated by an employer’s drug testing program and evaluating medical explanations for certain drug test results.
Negative result. The result reported by an HHS-certified laboratory to an MRO when a specimen contains no drug or the concentration of the drug is less than the cutoff concentration for the drug or drug class and the specimen is a valid specimen.
Non-negative specimen. A urine specimen that is reported as adulterated, substituted, positive (for drug(s) or drug metabolite(s)), and/or invalid.
Office of Drug and Alcohol Policy and Compliance (ODAPC). The office in the Office of the Secretary, DOT, that is responsible for coordinating drug and alcohol testing program matters within the Department and providing information concerning the implementation of this part.
Oxidizing adulterant. A substance that acts alone or in combination with other substances to oxidize drugs or drug metabolites to prevent the detection of the drug or drug metabolites, or affects the reagents in either the initial or confirmatory drug test.
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.
Positive result. The result reported by an HHS-certified laboratory when a specimen contains a drug or drug metabolite equal to or greater than the cutoff concentrations.
Qualification Training. The training required in order for a collector, BAT, MRO, SAP, or STT to be qualified to perform their functions in the DOT drug and alcohol testing program. Qualification training may be provided by any appropriate means (e.g., classroom instruction, internet application, CD-ROM, video).
Reconfirmed. The result reported for a split specimen when the second laboratory is able to corroborate the original result reported for the primary specimen.
Refresher Training. The training required periodically for qualified collectors, BATs, and STTs to review basic requirements and provide instruction concerning changes in technology (e.g., new testing methods that may be authorized) and amendments, interpretations, guidance, and issues concerning this part and DOT agency drug and alcohol testing regulations. Refresher training can be provided by any appropriate means (e.g., classroom instruction, internet application, CD-ROM, video).
Rejected for testing. The result reported by an HHS-certified laboratory when no tests are performed for a specimen because of a fatal flaw or a correctable flaw that is not corrected.
Screening drug test. See Initial drug test definition above.
Screening Test Technician (STT). A person who instructs and assists employees in the alcohol testing process and operates an ASD.
Secretary. The Secretary of Transportation or the Secretary’s designee.
Service agent. Any person or entity, other than an employee of the employer, who provides services to employers and/or employees in connection with DOT drug and alcohol testing requirements. This includes, but is not limited to, collectors, BATs and STTs, laboratories, MROs, substance abuse professionals, and C/TPAs. To act as service agents, persons and organizations must meet DOT qualifications, if applicable. Service agents are not employers for purposes of this part.
Shipping container. A container that is used for transporting and protecting urine specimen bottles and associated documents from the collection site to the laboratory.
Specimen bottle. The bottle that, after being sealed and labeled according to the procedures in this part, is used to hold the urine specimen during transportation to the laboratory.
Split specimen. In drug testing, a part of the urine specimen that is sent to a first laboratory and retained unopened, and which is transported to a second laboratory in the event that the employee requests that it be tested following a verified positive test of the primary specimen or a verified adulterated or substituted test result.
Split specimen collection. A collection in which the urine collected is divided into two separate specimen bottles, the primary specimen (Bottle A) and the split specimen (Bottle B).
Stand-down. The practice of 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 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 urine specimen with creatinine and specific gravity values that are so diminished or so divergent that they are not consistent with normal 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.
[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41950, Aug. 9, 2001; 71 FR 49384, Aug. 23, 2006; 71 FR 55347, Sept. 22, 2006; 73 FR 35969, June 25, 2008; 75 FR 49861, Aug. 16, 2010; 76 FR 59577, Sept. 27, 2011; 80 FR 19553, Apr. 13, 2015; 81 FR 52365, Aug. 8, 2016; 82 FR 52243, Nov. 13, 2017]
Must a test result be cancelled by the MRO when it is discovered the employee did not have a full three hours to provide a sufficient amount of urine?
• Not affording the employee a full three hours to provide a specimen is not automatically a basis for the MRO to cancel a test.
• The three hour time period is a maximum rather a minimum. But, to avoid potential issues about the fairness of the collection, collectors are advised to provide the full three hours.
• In each of the following examples, the collector could stop the collection process, thoroughly document the details and times on Copy 2 of the CCF, and inform the DER of the employee’s inability to provide a sufficient amount of urine:
— After 2 hours and 50 minutes, the employee informs the collector there is no reason to try again because he or she will not be able to provide a specimen. The collector terminates the collection.
— After 2 hours and 50 minutes, the employee requests to try again but provides another insufficient amount of urine. The collector terminates the collection because there is no practical possibility that the employee will provide the requisite amount in the next 10 minutes.
• In each of these two examples, the employee has had a fair opportunity to provide 45 mL of urine, and the test should not be cancelled because the full three-hour period was not used.
• The medical evaluation should be conducted to determine if there is a legitimate physiological condition or psychological disorder explanation for the employee’s inability to provide the requisite amount of urine.
• In situations where it appears the employee was not provided a fair opportunity to provide the requisite amount of urine, the MRO could cancel the test.
— For example, the collector terminates a collection after two hours because the collection site is closing and all collectors are leaving.
• Please note that it remains a refusal to test if the employee leaves the collection site without permission.
ODAPC and the DOT Office of General Counsel (OGC) provide written interpretations of the provisions of this part. These written DOT interpretations are the only official and authoritative interpretations concerning the provisions of this part. DOT agencies may incorporate ODAPC/OGC interpretations in written guidance they issue concerning drug and alcohol testing matters. Only Part 40 interpretations issued after August 1, 2001, are considered valid.
What must an MRO do when he or she determines that there is no split laboratory capable of testing the adulterant identified by the primary laboratory after the employee has asked for the split to be tested?
- The Department views this situation as closely paralleling the MRO reporting requirement, at 40.187(d), when the split specimen is not available for testing after the request to test the split is made by the employee. Therefore, the MRO needs to follow similar steps.
* The MRO must report to the employer that the specimen, “Failed to
Reconfirm: Split laboratory not Available for Testing.”
* The MRO must also report to the DER and the employee that the test
result must be cancelled and the reason for the cancellation.
* The MRO must direct the DER to ensure the immediate collection of
another specimen from the employee under direct observation, with
no notice give to the employee of this collection requirement
until immediately before the collection.
* Finally, the MRO must notify ODAPC of the failure to reconfirm.
- The result of the collection under direct observation will be the result of record for this testing event.
Mail, fax, or email to:
U.S. Department of Transportation, Office of Drug and Alcohol Policy and Compliance, W62-300, 1200 New Jersey Avenue SE., Washington, DC 20590, Fax: (202) 366-3897, Email: ODAPCWebMail@dot.gov.
The following items are required on each report:
Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
- DOT Specimen Results Reported (total number)
- Negative Results Reported (total number) Negative (number)
- Rejected for Testing Results Reported (total number) By Reason
(a) Fatal flaw (number)
(b) Uncorrected Flaw (number)
- Positive Results Reported (total number) By Drug
(a) Marijuana Metabolite (number)
(b) Cocaine Metabolite (number)
(c) Opioids (number)
(1) Codeine (number)
(2) Morphine (number)
(3) 6-AM (number)
(4) Hydrocodone (number)
(5) Hydromorphone (number)
(6) Oxycodone (number)
(7) Oxymorphone (number)
(d) Phencyclidine (number)
(e) Amphetamines (number)
(1) Amphetamine (number)
(2) Methamphetamine (number)
(3) MDMA (number)
(4) MDA (number)
- Adulterated Results Reported (total number) By Reason (number)
- Substituted Results Reported (total number)
- Invalid Results Reported (total number) By Reason (number)
(a) If you want an exemption from any provision of this part, you must request it in writing from the Office of the Secretary of Transportation, under the provisions and standards of 49 CFR part 5. You must send requests for an exemption to the following address: Department of Transportation, Deputy Assistant General Counsel for Regulation and Enforcement, 1200 New Jersey Avenue, SE., Washington, DC 20590.
(b) Under the standards of 49 CFR part 5, we will grant the request only if the request documents special or exceptional circumstances, not likely to be generally applicable and not contemplated in connection with the rulemaking that established this part, that make your compliance with a specific provision of this part impracticable.
(c) If we grant you an exemption, you must agree to take steps we specify to comply with the intent of the provision from which an exemption is granted.
(d) We will issue written responses to all exemption requests.
If an employee fails to provide a sufficient amount of urine during an observed collection, can an employer remove the employee from performing safety-sensitive functions pending receipt of the verified result from the Medical Review Officer (MRO)?
• The Department believes an employee’s failing to provide a sufficient amount of urine during a directly observed collection is very similar to a laboratory’s reporting a positive, adulterated, or substituted test result to MRO.
• While we do not believe it is appropriate for an employer to remove the employee from safety-sensitive duties until receiving the MRO’s verified result, we think stand-down waiver provisions could be relevant.
• Therefore, employers can apply for a stand-down waiver that would permit the employee to be removed from safety-sensitive duties when he or she does not provide an adequate amount of urine during an observed collection.
• The waiver request would need to meet all criteria outlined at 40.21 and should reference the fact that it is for standing an employee down who fails to provide an adequate amount of urine during an observed collection.
• The 40.21 waiver request for laboratory positive, adulterated, and substituted results will continue to be evaluated separately.
(a) As an employer, you are responsible for meeting all applicable requirements and procedures of this part.
(b) You are responsible for all actions of your officials, representatives, and agents (including service agents) in carrying out the requirements of the DOT agency regulations.
(c) All agreements and arrangements, written or unwritten, between and among employers and service agents concerning the implementation of DOT drug and alcohol testing requirements are deemed, as a matter of law, to require compliance with all applicable provisions of this part and DOT agency drug and alcohol testing regulations. Compliance with these provisions is a material term of all such agreements and arrangements.
What are some examples of an employee’s failure to cooperate with the testing process that would cause a refusal to test and how should the collector handle them?
• Part 40 highlights two examples of failure to cooperate – the employee refuses to empty pockets when instructed to do so; and the employee behaves in a confrontational way that disrupts the testing process.
• Among others are:
— The employee fails to wash his or her hands after being directed to do so by the collector.
— The employee admits to the collector that he or she adulterated or substituted the specimen; and
— The employee is found to have a device – such as a prosthetic appliance – the purpose of which is to interfere with providing an actual urine specimen.
• When the issue is a problem with refusing to following instructions – for example, refusing to empty pockets or refusing to wash hands – or if there is a confrontation, the collector should warn the employee of potential consequences of a failure to cooperate; and if practical, seek assistance from the DER or supervisor to ensure that the employee understands the ramifications.
• When the issue is admission of adulteration or substitution or when a device is found, there is no need for the collector to warn the employee or to seek assistance from the DER or supervisor.
• In every case, the collector must carefully follow the procedures at 40.191(d) by terminating the collection process, immediately notifying the DER of the refusal, and thoroughly documenting the circumstances surrounding the event in the remarks section of the CCF.
• Any specimen that had been collected before the refusal should be discarded.
(a) DOT tests must be completely separate from non-DOT tests in all respects.
(b) DOT tests must take priority and must be conducted and completed before a non-DOT test is begun. For example, you must discard any excess urine left over from a DOT test and collect a separate void for the subsequent non-DOT test.
(c) Except as provided in paragraph (d) of this section, you must not perform any tests on DOT urine or breath specimens other than those specifically authorized by this part or DOT agency regulations. For example, you may not test a DOT urine specimen for additional drugs, and a laboratory is prohibited from making a DOT urine specimen available for a DNA test or other types of specimen identity testing.
(d) The single exception to paragraph (c) of this section is when a DOT drug test collection is conducted as part of a physical examination required by DOT agency regulations. It is permissible to conduct required medical tests related to this physical examination (e.g., for glucose) on any urine remaining in the collection container after the drug test urine specimens have been sealed into the specimen bottles.
(e) No one is permitted to change or disregard the results of DOT tests based on the results of non-DOT tests. For example, as an employer you must not disregard a verified positive DOT drug test result because the employee presents a negative test result from a blood or urine specimen collected by the employee’s physician or a DNA test result purporting to question the identity of the DOT specimen.
(f) As an employer, you must not use the CCF or the ATF in your non-DOT drug and alcohol testing programs. This prohibition includes the use of the DOT forms with references to DOT programs and agencies crossed out. You also must always use the CCF and ATF for all your DOT-mandated drug and alcohol tests.
Are there any circumstances for which an employee should be given more than 3 hours and 40 ounces of fluids to provide a sufficient amount of urine during a collection?
• No. The Department sees no situations for which an employee should be given more than 3 hours and offered more than 40 ounces of fluids to provide a sufficient amount of urine after the “first unsuccessful attempt” to do so [see §40.193(b)(4)].
• The Department regards the “first unsuccessful attempt” to be very first time the employee comes out of the urination area with less than 45 mL of urine.
• This is true about the “first unsuccessful attempt” even if a subsequent attempt during the three-hour period requires an immediate collection under direct observation because the specimen is outside the appropriate temperature range or shows signs of tampering [see §40.65(b)&(c)].
• For example: An employee presents an insufficient amount of urine at noon and is urged by the collector to drink up to 40 ounces of fluid distributed through a period of up to 3 hours (3 o’clock, in this example).
— At 2 o’clock, the employee indicates that he or she can now provide the specimen, enters the collection area, but returns with a specimen outside the acceptable temperature range.
— The collector immediately conducts an observed collection, but the employee – for the second time during this collection event, which began at noon – provides less than 45 mL of urine.
— The employee has up to 3 o’clock and any remaining fluids to provide an adequate amount of urine under direct observation: The employee is not given an additional three hours and is not offered an additional 40 ounces of fluids.
— If the employee ultimately fails to provide a sufficient amount of urine during the remaining time, the collector discontinues the collection, discards any specimen the employee previously provided, appropriately documents the CCF, and immediately notifies the DER and the MRO – following the requirements at §40.193(b)(4) and (b)(5).
(a) As an employer, you may use a service agent to perform the tasks needed to comply with this part and DOT agency drug and alcohol testing regulations, consistent with the requirements of Subpart Q and other applicable provisions of this part.
(b) As an employer, you are responsible for ensuring that the service agents you use meet the qualifications set forth in this part (e.g., §40.121 for MROs). You may require service agents to show you documentation that they meet the requirements of this part (e.g., documentation of MRO qualifications required by §40.121(e)).
(c) You remain responsible for compliance with all applicable requirements of this part and other DOT drug and alcohol testing regulations, even when you use a service agent. If you violate this part or other DOT drug and alcohol testing regulations because a service agent has not provided services as our rules require, a DOT agency can subject you to sanctions. Your good faith use of a service agent is not a defense in an enforcement action initiated by a DOT agency in which your alleged noncompliance with this part or a DOT agency drug and alcohol regulation may have resulted from the service agent’s conduct.
(d) As an employer, you must not permit a service agent to act as your DER.
Yes, as an employer, you are responsible for obtaining information required by this part from your service agents. This is true whether or not you choose to use a C/TPA as an intermediary in transmitting information to you. For example, suppose an applicant for a safety-sensitive job takes a pre-employment drug test, but there is a significant delay in your receipt of the test result from an MRO or C/TPA. You must not assume that “no news is good news” and permit the applicant to perform safety-sensitive duties before receiving the result. This is a violation of the Department’s regulations.
§ 40.21 May an employer stand down an employee before the MRO has completed the verification process?
(a) As an employer, you are prohibited from standing employees down, except consistent with a waiver a DOT agency grants under this section.
(b) You may make a request to the concerned DOT agency for a waiver from the prohibition of paragraph (a) of this section. Such a waiver, if granted, permits you to stand an employee down following the MRO’s receipt of a laboratory report of a confirmed positive test for a drug or drug metabolite, an adulterated test, or a substituted test pertaining to the employee.
(1) For this purpose, the concerned DOT agency is the one whose drug and alcohol testing rules apply to the majority of the covered employees in your organization. The concerned DOT agency uses its applicable procedures for considering requests for waivers.
(2) Before taking action on a waiver request, the concerned DOT agency coordinates with other DOT agencies that regulate the employer’s other covered employees.
(3) The concerned DOT agency provides a written response to each employer that petitions for a waiver, setting forth the reasons for the agency’s decision on the waiver request.
(c) Your request for a waiver must include, as a minimum, the following elements:
(1) Information about your organization:
(i) Your determination that standing employees down is necessary for safety in your organization and a statement of your basis for it, including any data on safety problems or incidents that could have been prevented if a stand-down procedure had been in place;
(ii) Data showing the number of confirmed laboratory positive, adulterated, and substituted test results for your employees over the two calendar years preceding your waiver request, and the number and percentage of those test results that were verified positive, adulterated, or substituted by the MRO;
(iii) Information about the work situation of the employees subject to stand-down, including a description of the size and organization of the unit(s) in which the employees work, the process through which employees will be informed of the stand-down, whether there is an in-house MRO, and whether your organization has a medical disqualification or stand-down policy for employees in situations other than drug and alcohol testing; and
(iv) A statement of which DOT agencies regulate your employees.
(2) Your proposed written company policy concerning stand-down, which must include the following elements:
(i) Your assurance that you will distribute copies of your written policy to all employees that it covers;
(ii) Your means of ensuring that no information about the confirmed positive, adulterated, or substituted test result or the reason for the employee’s temporary removal from performance of safety-sensitive functions becomes available, directly or indirectly, to anyone in your organization (or subsequently to another employer) other than the employee, the MRO and the DER;
(iii) Your means of ensuring that all covered employees in a particular job category in your organization are treated the same way with respect to stand-down;
(iv) Your means of ensuring that a covered employee will be subject to stand-down only with respect to the actual performance of safety-sensitive duties;
(v) Your means of ensuring that you will not take any action adversely affecting the employee’s pay and benefits pending the completion of the MRO’s verification process. This includes continuing to pay the employee during the period of the stand-down in the same way you would have paid him or her had he or she not been stood down;
(vi) Your means of ensuring that the verification process will commence no later than the time an employee is temporarily removed from the performance of safety-sensitive functions and that the period of stand-down for any employee will not exceed five days, unless you are informed in writing by the MRO that a longer period is needed to complete the verification process; and
(vii) Your means of ensuring that, in the event that the MRO verifies the test negative or cancels it—
(A) You return the employee immediately to the performance of safety-sensitive duties;
(B) The employee suffers no adverse personnel or financial consequences as a result; and
(C) You maintain no individually identifiable record that the employee had a confirmed laboratory positive, adulterated, or substituted test result (i.e., you maintain a record of the test only as a negative or cancelled test).
(d) The Administrator of the concerned DOT agency, or his or her designee, may grant a waiver request only if he or she determines that, in the context of your organization, there is a high probability that the procedures you propose will effectively enhance safety and protect the interests of employees in fairness and confidentiality.
(1) The Administrator, or his or her designee, may impose any conditions he or she deems appropriate on the grant of a waiver.
(2) The Administrator, or his or her designee, may immediately suspend or revoke the waiver if he or she determines that you have failed to protect effectively the interests of employees in fairness and confidentiality, that you have failed to comply with the requirements of this section, or that you have failed to comply with any other conditions the DOT agency has attached to the waiver.
(e) You must not stand employees down in the absence of a waiver, or inconsistent with the terms of your waiver. If you do, you are in violation of this part and DOT agency drug testing regulations, and you are subject to enforcement action by the DOT agency just as you are for other violations of this part and DOT agency rules.
(a) As an employer who receives a verified positive drug test result, you must immediately remove the employee involved from performing safety-sensitive functions. You must take this action upon receiving the initial report of the verified positive test result. Do not wait to receive the written report or the result of a split specimen test.
(b) As an employer who receives a verified adulterated or substituted drug test result, you must consider this a refusal to test and immediately remove the employee involved from performing safety-sensitive functions. You must take this action on receiving the initial report of the verified adulterated or substituted test result. Do not wait to receive the written report or the result of a split specimen test.
(c) As an employer who receives an alcohol test result of 0.04 or higher, you must immediately remove the employee involved from performing safety-sensitive functions. If you receive an alcohol test result of 0.02-0.039, you must temporarily remove the employee involved from performing safety-sensitive functions, as provided in applicable DOT agency regulations. Do not wait to receive the written report of the result of the test.
(d) As an employer, when an employee has a verified positive, adulterated, or substituted test result, or has otherwise violated a DOT agency drug and alcohol regulation, you must not return the employee to the performance of safety-sensitive functions until or unless the employee successfully completes the return-to-duty process of Subpart O of this part.
(e) As an employer who receives a drug test result indicating that the employee’s specimen was dilute, take action as provided in §40.197.
(f) As an employer who receives a drug test result indicating that the employee’s urine specimen test was cancelled because it was invalid and that a second collection must take place under direct observation—
(1) You must immediately direct the employee to provide a new specimen under direct observation.
(2) You must not attach consequences to the finding that the test was invalid other than collecting a new specimen under direct observation.
(3) You must not give any advance notice of this test requirement to the employee.
(4) You must instruct the collector to note on the CCF the same reason (e.g., random test, post-accident test) and DOT Agency (e.g., check DOT and FMCSA) as for the original collection.
(5) You must ensure that the collector conducts the collection under direct observation.
(g) As an employer who receives a cancelled test result when a negative result is required (e.g., pre-employment, return-to-duty, or follow-up test), you must direct the employee to provide another specimen immediately.
(h) As an employer, you may also be required to take additional actions required by DOT agency regulations (e.g., FAA rules require some positive drug tests to be reported to the Federal Air Surgeon).
(i) As an employer, you must not alter a drug or alcohol test result transmitted to you by an MRO, BAT, or C/TPA.
§ 40.25 Must an employer check on the drug and alcohol testing record of employees it is intending to use to perform safety-sensitive duties?
(a) Yes, as an employer, you must, after obtaining an employee’s written consent, request the information about the employee listed in paragraph (b) of this section. This requirement applies only to employees seeking to begin performing safety-sensitive duties for you for the first time (i.e., a new hire, an employee transfers into a safety-sensitive position). If the employee refuses to provide this written consent, you must not permit the employee to perform safety-sensitive functions.
(b) You must request the information listed in this paragraph (b) from DOT-regulated employers who have employed the employee during any period during the two years before the date of the employee’s application or transfer:
(1) Alcohol tests with a result of 0.04 or higher alcohol concentration;
(2) Verified positive drug tests;
(3) Refusals to be tested (including verified adulterated or substituted drug test results);
(4) Other violations of DOT agency drug and alcohol testing regulations; and
(5) With respect to any employee who violated a DOT drug and alcohol regulation, documentation of the employee’s successful completion of DOT return-to-duty requirements (including follow-up tests). If the previous employer does not have information about the return-do-duty process (e.g., an employer who did not hire an employee who tested positive on a pre-employment test), you must seek to obtain this information from the employee.
(c) The information obtained from a previous employer includes any drug or alcohol test information obtained from previous employers under this section or other applicable DOT agency regulations.
(d) If feasible, you must obtain and review this information before the employee first performs safety-sensitive functions. If this is not feasible, you must obtain and review the information as soon as possible. However, you must not permit the employee to perform safety-sensitive functions after 30 days from the date on which the employee first performed safety-sensitive functions, unless you have obtained or made and documented a good faith effort to obtain this information.
(e) If you obtain information that the employee has violated a DOT agency drug and alcohol regulation, you must not use the employee to perform safety-sensitive functions unless you also obtain information that the employee has subsequently complied with the return-to-duty requirements of Subpart O of this part and DOT agency drug and alcohol regulations.
(f) You must provide to each of the employers from whom you request information under paragraph (b) of this section written consent for the release of the information cited in paragraph (a) of this section.
(g) The release of information under this section must be in any written form (e.g., fax, e-mail, letter) that ensures confidentiality. As the previous employer, you must maintain a written record of the information released, including the date, the party to whom it was released, and a summary of the information provided.
(h) If you are an employer from whom information is requested under paragraph (b) of this section, you must, after reviewing the employee’s specific, written consent, immediately release the requested information to the employer making the inquiry.
(i) As the employer requesting the information required under this section, you must maintain a written, confidential record of the information you obtain or of the good faith efforts you made to obtain the information. You must retain this information for three years from the date of the employee’s first performance of safety-sensitive duties for you.
(j) As the employer, you must also ask the employee whether he or she has tested positive, or refused to test, on any pre-employment drug or alcohol test administered by an employer to which the employee applied for, but did not obtain, safety-sensitive transportation work covered by DOT agency drug and alcohol testing rules during the past two years. If the employee admits that he or she had a positive test or a refusal to test, you must not use the employee to perform safety-sensitive functions for you, until and unless the employee documents successful completion of the return-to-duty process (see paragraphs (b)(5) and (e) of this section).
§ 40.27 May an employer require an employee to sign a consent or release in connection with the DOT drug and alcohol testing program?
No, as an employer, you must not require an employee to sign a consent, release, waiver of liability, or indemnification agreement with respect to any part of the drug or alcohol testing process covered by this part (including, but not limited to, collections, laboratory testing, MRO and SAP services).
You can find other information on the responsibilities of employers in the following sections of this part:
§40.35—Information about DERs that employers must provide collectors.
§40.45—Modifying CCFs, Use of foreign-language CCFs.
§40.47—Use of non-Federal forms for DOT tests or Federal CCFs for non-DOT tests.
§40.67—Requirements for direct observation.
§40.173—Responsibility to ensure test of split specimen.
§40.193—Action in “shy bladder” situations.
§40.197—Actions following report of a dilute specimen.
§40.207—Actions following a report of a cancelled drug test.
§40.209—Actions following and consequences of non-fatal flaws in drug tests.
§40.215—Information about DERs that employers must provide BATs and STTs.
§40.225—Modifying ATFs; use of foreign-language ATFs.
§40.227—Use of non-DOT forms for DOT tests or DOT ATFs for non-DOT tests.
§40.235 (c) and (d)—responsibility to follow instructions for ASDs.
§40.255 (b)—receipt and storage of alcohol test information.
§40.265 (c)-(e)—actions in “shy lung” situations.
§40.267—Cancellation of alcohol tests.
§40.271—Actions in “correctable flaw” situations in alcohol tests.
§40.273—Actions following cancelled tests in alcohol tests.
§40.275—Actions in “non-fatal flaw” situations in alcohol tests.
§§40.287-40.289—Responsibilities concerning SAP services.
§§40.295-40.297—Prohibition on seeking second SAP evaluation or changing SAP recommendation.
§40.303—Responsibilities concerning aftercare recommendations.
§40.305—Responsibilities concerning return-to-duty decision.
§40.309—Responsibilities concerning follow-up tests.
§40.321—General confidentiality requirement.
§40.323—Release of confidential information in litigation.
§40.331—Other circumstances for the release of confidential information.
§40.333—Record retention requirements.
§40.345—Choice of who reports drug testing information to employers.
(a) Collectors meeting the requirements of this subpart are the only persons authorized to collect urine specimens for DOT drug testing.
(b) A collector must meet training requirements of §40.33.
(c) As the immediate supervisor of an employee being tested, you may not act as the collector when that employee is tested, unless no other collector is available and you are permitted to do so under DOT agency drug and alcohol regulations.
(d) You must not act as the collector for the employee being tested if you work for a HHS-certified laboratory (e.g., as a technician or accessioner) and could link the employee with a urine specimen, drug testing result, or laboratory report.
To be permitted to act as a collector in the DOT drug testing program, you must meet each of the requirements of this section:
(a) Basic information. You must be knowledgeable about this part, the current “DOT Urine Specimen Collection Procedures Guidelines,” and DOT agency regulations applicable to the employers for whom you perform collections. DOT agency regulations, the DOT Urine Specimen Collection Procedures Guidelines, and other materials are available from ODAPC (Department of Transportation, 1200 New Jersey Avenue SE., Washington DC, 20590, 202-366-3784, or on the ODAPC Web site (https://www.transportation.gov/odapc). You must keep current on any changes to these materials. You must subscribe to the ODAPC list-serve at: https://www.transportation.gov/odapc/get-odapc-email-updates.
(b) Qualification training. You must receive qualification training meeting the requirements of this paragraph. Qualification training must provide instruction on the following subjects:
(1) All steps necessary to complete a collection correctly and the proper completion and transmission of the CCF;
(2) “Problem” collections (e.g., situations like “shy bladder” and attempts to tamper with a specimen);
(3) Fatal flaws, correctable flaws, and how to correct problems in collections; and
(4) The collector’s responsibility for maintaining the integrity of the collection process, ensuring the privacy of employees being tested, ensuring the security of the specimen, and avoiding conduct or statements that could be viewed as offensive or inappropriate;
(c) Initial Proficiency Demonstration. Following your completion of qualification training under paragraph (b) of this section, you must demonstrate proficiency in collections under this part by completing five consecutive error-free mock collections.
(1) The five mock collections must include two uneventful collection scenarios, one insufficient quantity of urine scenario, one temperature out of range scenario, and one scenario in which the employee refuses to sign the CCF and initial the specimen bottle tamper-evident seal.
(2) Another person must monitor and evaluate your performance, in person or by a means that provides real-time observation and interaction between the instructor and trainee, and attest in writing that the mock collections are “error-free.” This person must be a qualified collector who has demonstrated necessary knowledge, skills, and abilities by—
(i) Regularly conducting DOT drug test collections for a period of at least a year;
(ii) Conducting collector training under this part for a year; or
(iii) Successfully completing a “train the trainer” course.
(d) You must meet the requirements of paragraphs (b) and (c) of this section before you begin to perform collector functions.
(e) Refresher training. No less frequently than every five years from the date on which you satisfactorily complete the requirements of paragraphs (b) and (c) of this section, you must complete refresher training that meets all the requirements of paragraphs (b) and (c) of this section.
(f) Error Correction Training. If you make a mistake in the collection process that causes a test to be cancelled (i.e., a fatal or uncorrected flaw), you must undergo error correction training. This training must occur within 30 days of the date you are notified of the error that led to the need for retraining.
(1) Error correction training must be provided and your proficiency documented in writing by a person who meets the requirements of paragraph (c)(2) of this section.
(2) Error correction training is required to cover only the subject matter area(s) in which the error that caused the test to be cancelled occurred.
(3) As part of the error correction training, you must demonstrate your proficiency in the collection procedures of this part by completing three consecutive error-free mock collections. The mock collections must include one uneventful scenario and two scenarios related to the area(s) in which your error(s) occurred. The person providing the training must monitor and evaluate your performance and attest in writing that the mock collections were “error-free.”
(g) Documentation. You must maintain documentation showing that you currently meet all requirements of this section. You must provide this documentation on request to DOT agency representatives and to employers and C/TPAs who are using or negotiating to use your services.
As an employer, you must provide to collectors the name and telephone number of the appropriate DER (and C/TPA, where applicable) to contact about any problems or issues that may arise during the testing process.
You can find other information on the role and functions of collectors in the following sections of this part:
§40.43—Steps to prepare and secure collection sites.
§§40.45-40.47—Use of CCF.
§§40.49-40.51—Use of collection kit and shipping materials.
§§40.61-40.63—Preliminary steps in collections.
§40.65—Role in checking specimens.
§40.67—Role in directly observed collections.
§40.69—Role in monitored collections.
§40.71—Role in split specimen collections.
§40.73—Chain of custody completion and finishing the collection process.
§40.191—Action in case of refusals to take test.
§40.193—Action in “shy bladder” situations.
§40.199-40.205—Collector errors in tests, effects, and means of correction.
(a) A urine collection for a DOT drug test must take place in a collection site meeting the requirements of this section.
(b) If you are operating a collection site, you must ensure that it meets the security requirements of §40.43.
(c) If you are operating a collection site, you must have all necessary personnel, materials, equipment, facilities and supervision to provide for the collection, temporary storage, and shipping of urine specimens to a laboratory, and a suitable clean surface for writing.
(d) Your collection site must include a facility for urination described in either paragraph (e) or paragraph (f) of this section.
(e) The first, and preferred, type of facility for urination that a collection site may include is a single-toilet room, having a full-length privacy door, within which urination can occur.
(1) No one but the employee may be present in the room during the collection, except for the observer in the event of a directly observed collection.
(2) You must have a source of water for washing hands, that, if practicable, should be external to the closed room where urination occurs. If an external source is not available, you may meet this requirement by securing all sources of water and other substances that could be used for adulteration and substitution (e.g., water faucets, soap dispensers) and providing moist towelettes outside the closed room.
(f) The second type of facility for urination that a collection site may include is a multistall restroom.
(1) Such a site must provide substantial visual privacy (e.g., a toilet stall with a partial-length door) and meet all other applicable requirements of this section.
(2) If you use a multi-stall restroom, you must either—
(i) Secure all sources of water and other substances that could be used for adulteration and substitution (e.g., water faucets, soap dispensers) and place bluing agent in all toilets or secure the toilets to prevent access; or
(ii) Conduct all collections in the facility as monitored collections (see §40.69 for procedures). This is the only circumstance in which you may conduct a monitored collection.
(3) No one but the employee may be present in the multistall restroom during the collection, except for the monitor in the event of a monitored collection or the observer in the event of a directly observed collection.
(g) A collection site may be in a medical facility, a mobile facility (e.g., a van), a dedicated collection facility, or any other location meeting the requirements of this section.
§ 40.43 What steps must operators of collection sites take to protect the security and integrity of urine collections?
(a) Collectors and operators of collection sites must take the steps listed in this section to prevent unauthorized access that could compromise the integrity of collections.
(b) As a collector, you must do the following before each collection to deter tampering with specimens:
(1) Secure any water sources or otherwise make them unavailable to employees (e.g., turn off water inlet, tape handles to prevent opening faucets);
(2) Ensure that the water in the toilet is blue;
(3) Ensure that no soap, disinfectants, cleaning agents, or other possible adulterants are present;
(4) Inspect the site to ensure that no foreign or unauthorized substances are present;
(5) Tape or otherwise secure shut any movable toilet tank top, or put bluing in the tank;
(6) Ensure that undetected access (e.g., through a door not in your view) is not possible;
(7) Secure areas and items (e.g., ledges, trash receptacles, paper towel holders, under-sink areas) that appear suitable for concealing contaminants; and
(8) Recheck items in paragraphs (b)(1) through (7) of this section following each collection to ensure the site’s continued integrity.
(c) If the collection site uses a facility normally used for other purposes, like a public rest room or hospital examining room, you must, as a collector, also ensure before the collection that:
(1) Access to collection materials and specimens is effectively restricted; and
(2) The facility is secured against access during the procedure to ensure privacy to the employee and prevent distraction of the collector. Limited-access signs must be posted.
(d) As a collector, you must take the following additional steps to ensure security during the collection process:
(1) To avoid distraction that could compromise security, you are limited to conducting a collection for only one employee at a time. However, during the time one employee is in the period for drinking fluids in a “shy bladder” situation (see §40.193(b)), you may conduct a collection for another employee.
(2) To the greatest extent you can, keep an employee’s collection container within view of both you and the employee between the time the employee has urinated and the specimen is sealed.
(3) Ensure you are the only person in addition to the employee who handles the specimen before it is poured into the bottles and sealed with tamper-evident seals.
(4) In the time between when the employee gives you the specimen and when you seal the specimen, remain within the collection site.
(5) Maintain personal control over each specimen and CCF throughout the collection process.
(e) If you are operating a collection site, you must implement a policy and procedures to prevent unauthorized personnel from entering any part of the site in which urine specimens are collected or stored.
(1) Only employees being tested, collectors and other collection site workers, DERs, employee and employer representatives authorized by the employer (e.g., employer policy, collective bargaining agreement), and DOT agency representatives are authorized persons for purposes of this paragraph (e).
(2) Except for the observer in a directly observed collection or the monitor in the case of a monitored collection, you must not permit anyone to enter the urination facility in which employees provide specimens.
(3) You must ensure that all authorized persons are under the supervision of a collector at all times when permitted into the site.
(4) You or the collector may remove any person who obstructs, interferes with, or causes a delay in the collection process.
(f) If you are operating a collection site, you must minimize the number of persons handling specimens.
(a) The Federal Drug Testing Custody and Control Form (CCF) must be used to document every urine collection required by the DOT drug testing program. You may view this form on the Department’s Web site (http://www.transportation.gov/odapc) or the HHS Web site (http://www.workplace.samhsa.gov).
(b) You must not use a non-Federal form or an expired CCF to conduct a DOT urine collection. As a laboratory, C/TPA or other party that provides CCFs to employers, collection sites, or other customers, you must not provide copies of an expired CCF to these participants. You must also affirmatively notify these participants that they must not use an expired CCF.
(c) As a participant in the DOT drug testing program, you are not permitted to modify or revise the CCF except as follows:
(1) You may include, in the area outside the border of the form, other information needed for billing or other purposes necessary to the collection process.
(2) The CCF must include the names, addresses, telephone numbers and fax numbers of the employer and the MRO, which may be preprinted, typed, or handwritten. The MRO information must include the specific physician’s name and address, as opposed to only a generic clinic, health care organization, or company name. This information is required, and it is prohibited for an employer, collector, service agent or any other party to omit it. In addition, a C/TPA’s name, address, fax number, and telephone number may be included, but is not required. The employer may use a C/TPA’s address in place of its own, but must continue to include its name, telephone number, and fax number.
(3) As an employer, in Step 1-D of the CCF you may preprint the box for the DOT Agency under whose authority the test will occur.
(4) As a collector, you may use a CCF with your name, address, telephone number, and fax number preprinted, but under no circumstances may you sign the form before the collection event.
(5) When using an electronic CCF, you must establish adequate confidentiality and security measures to ensure that confidential employee records are not available to unauthorized persons. This includes protecting the physical security of records, access controls, and computer security measures to safeguard confidential data in electronic form.
(d) Under no circumstances may the CCF transmit personal identifying information about an employee (other than a social security number (SSN) or other employee identification (ID) number) to a laboratory.
(e) As an employer, you may use an equivalent foreign-language version of the CCF approved by ODAPC. You may use such a non-English language form only in a situation where both the employee and collector understand and can use the form in that language.
(f) An employer who uses an electronic CCF must ensure that the collection site, the primary and split laboratories, and MRO have compatible systems, and that the employee and any other program participants in the testing process will receive a legible copy of the CCF.
§ 40.47 May employers use the CCF for non-DOT collections or non-Federal forms for DOT collections?
(a) No, as an employer, you are prohibited from using the CCF for non-Federal urine collections. You are also prohibited from using non-Federal forms for DOT urine collections. Doing either subjects you to enforcement action under DOT agency regulations.
(b) (1) In the rare case where the collector, either by mistake or as the only means to conduct a test under difficult circumstances (e.g., post-accident or reasonable suspicion test with insufficient time to obtain the CCF), uses a non-Federal form for a DOT collection, the use of a non-Federal form does not present a reason for the laboratory to reject the specimen for testing or for an MRO to cancel the result.
(2) The use of the non-Federal form is a “correctable flaw.” As an MRO, to correct the problem you must follow the procedures of §40.205(b)(2).
For each DOT drug test, you must use a collection kit meeting the requirements of Appendix A of this part.
(a) Except as provided in paragraph (b) of this section, you must use a shipping container that adequately protects the specimen bottles from shipment damage in the transport of specimens from the collection site to the laboratory.
(b) You are not required to use a shipping container if a laboratory courier hand-delivers the specimens from the collection site to the laboratory.
As the collector, you must take the following steps before actually beginning a collection:
(a) When a specific time for an employee’s test has been scheduled, or the collection site is at the employee’s work site, and the employee does not appear at the collection site at the scheduled time, contact the DER to determine the appropriate interval within which the DER has determined the employee is authorized to arrive. If the employee’s arrival is delayed beyond that time, you must notify the DER that the employee has not reported for testing. In a situation where a C/TPA has notified an owner/operator or other individual employee to report for testing and the employee does not appear, the C/TPA must notify the employee that he or she has refused to test (see §40.191(a)(1)).
(b) Ensure that, when the employee enters the collection site, you begin the testing process without undue delay. For example, you must not wait because the employee says he or she is not ready or is unable to urinate or because an authorized employer or employee representative is delayed in arriving.
(1) If the employee is also going to take a DOT alcohol test, you must, to the greatest extent practicable, ensure that the alcohol test is completed before the urine collection process begins.
Example to paragraph (b)(1): An employee enters the test site for both a drug and an alcohol test. Normally, the collector would wait until the BAT had completed the alcohol test process before beginning the drug test process. However, there are some situations in which an exception to this normal practice would be reasonable. One such situation might be if several people were waiting for the BAT to conduct alcohol tests, but a drug testing collector in the same facility were free. Someone waiting might be able to complete a drug test without unduly delaying his or her alcohol test. Collectors and BATs should work together, however, to ensure that post-accident and reasonable suspicion alcohol tests happen as soon as possible (e.g., by moving the employee to the head of the line for alcohol tests).
(2) If the employee needs medical attention (e.g., an injured employee in an emergency medical facility who is required to have a post-accident test), do not delay this treatment to collect a specimen.
(3) You must not collect, by catheterization or other means, urine from an unconscious employee to conduct a drug test under this part. Nor may you catheterize a conscious employee. However, you must inform an employee who normally voids through self-catheterization that the employee is required to provide a specimen in that manner.
(4) If, as an employee, you normally void through self-catheterization, and decline to do so, this constitutes a refusal to test.
(c) Require the employee to provide positive identification. You must see a photo ID issued by the employer (other than in the case of an owner-operator or other self-employed individual) or a Federal, state, or local government (e.g., a driver’s license). You may not accept faxes or photocopies of identification. Positive identification by an employer representative (not a co-worker or another employee being tested) is also acceptable. If the employee cannot produce positive identification, you must contact a DER to verify the identity of the employee.
(d) If the employee asks, provide your identification to the employee. Your identification must include your name and your employer’s name, but does not have to include your picture, address, or telephone number.
(e) Explain the basic collection procedure to the employee, including showing the employee the instructions on the back of the CCF.
(f) Direct the employee to remove outer clothing (e.g., coveralls, jacket, coat, hat) that could be used to conceal items or substances that could be used to tamper with a specimen. You must also direct the employee to leave these garments and any briefcase, purse, or other personal belongings with you or in a mutually agreeable location. You must advise the employee that failure to comply with your directions constitutes a refusal to test.
(1) If the employee asks for a receipt for any belongings left with you, you must provide one.
(2) You must allow the employee to keep his or her wallet.
(3) You must not ask the employee to remove other clothing (e.g., shirts, pants, dresses, underwear), to remove all clothing, or to change into a hospital or examination gown (unless the urine collection is being accomplished simultaneously with a DOT agency-authorized medical examination).
(4) You must direct the employee to empty his or her pockets and display the items in them to ensure that no items are present which could be used to adulterate the specimen. If nothing is there that can be used to adulterate a specimen, the employee can place the items back into his or her pockets. As the employee, you must allow the collector to make this observation.
(5) If, in your duties under paragraph (f)(4) of this section, you find any material that could be used to tamper with a specimen, you must:
(i) Determine if the material appears to be brought to the collection site with the intent to alter the specimen, and, if it is, conduct a directly observed collection using direct observation procedures (see §40.67); or
(ii) Determine if the material appears to be inadvertently brought to the collection site (e.g., eye drops), secure and maintain it until the collection process is completed and conduct a normal (i.e., unobserved) collection.
(g) You must instruct the employee not to list medications that he or she is currently taking on the CCF. (The employee may make notes of medications on the back of the employee copy of the form for his or her own convenience, but these notes must not be transmitted to anyone else.)
§ 40.63 What steps does the collector take in the collection process before the employee provides a urine specimen?
As the collector, you must take the following steps before the employee provides the urine specimen:
(a) Complete Step 1 of the CCF.
(b) Instruct the employee to wash and dry his or her hands at this time. You must tell the employee not to wash his or her hands again until after delivering the specimen to you. You must not give the employee any further access to water or other materials that could be used to adulterate or dilute a specimen.
(c) Select, or allow the employee to select, an individually wrapped or sealed collection container from collection kit materials. Either you or the employee, with both of you present, must unwrap or break the seal of the collection container. You must not unwrap or break the seal on any specimen bottle at this time. You must not allow the employee to take anything from the collection kit into the room used for urination except the collection container.
(d) Direct the employee to go into the room used for urination, provide a specimen of at least 45 mL, not flush the toilet, and return to you with the specimen as soon as the employee has completed the void.
(1) Except in the case of an observed or a monitored collection (see §§40.67 and 40.69), neither you nor anyone else may go into the room with the employee.
(2) As the collector, you may set a reasonable time limit for voiding.
(e) You must pay careful attention to the employee during the entire collection process to note any conduct that clearly indicates an attempt to tamper with a specimen (e.g., substitute urine in plain view or an attempt to bring into the collection site an adulterant or urine substitute). If you detect such conduct, you must require that a collection take place immediately under direct observation (see §40.67) and complete Step 2 by noting the conduct in the “Remarks” line of the CCF and the fact that the collection was observed by checking the “Observed” box. You must also, as soon as possible, inform the DER and collection site supervisor that a collection took place under direct observation and the reason for doing so.
As a collector, you must check the following when the employee gives the collection container to you:
(a) Sufficiency of specimen. You must check to ensure that the specimen contains at least 45 mL of urine.
(1) If it does not, you must follow “shy bladder” procedures (see §40.193(b)).
(2) When you follow “shy bladder” procedures, you must discard the original specimen, unless another problem (i.e., temperature out of range, signs of tampering) also exists.
(3) You are never permitted to combine urine collected from separate voids to create a specimen.
(4) You must discard any excess urine.
(b) Temperature. You must check the temperature of the specimen no later than four minutes after the employee has given you the specimen.
(1) The acceptable temperature range is 32-38 °C/90-100 °F.
(2) You must determine the temperature of the specimen by reading the temperature strip attached to the collection container.
(3) If the specimen temperature is within the acceptable range, you must mark the “Yes” box on the CCF (Step 2).
(4) If the specimen temperature is outside the acceptable range, you must mark the “No” box and enter in the “Remarks” line (Step 2) your findings about the temperature.
(5) If the specimen temperature is outside the acceptable range, you must immediately conduct a new collection using direct observation procedures (see §40.67).
(6) In a case where a specimen is collected under direct observation because of the temperature being out of range, you must process both the original specimen and the specimen collected using direct observation and send the two sets of specimens to the laboratory. This is true even in a case in which the original specimen has insufficient volume but the temperature is out of range. You must also, as soon as possible, inform the DER and collection site supervisor that a collection took place under direct observation and the reason for doing so.
(7) In a case where the employee refuses to provide another specimen (see §40.191(a)(3)) or refuses to provide another specimen under direct observation (see §40.191(a)(4)), you must notify the DER. As soon as you have notified the DER, you must discard any specimen the employee has provided previously during the collection procedure.
(c) Signs of tampering. You must inspect the specimen for unusual color, presence of foreign objects or material, or other signs of tampering (e.g., if you notice any unusual odor).
(1) If it is apparent from this inspection that the employee has tampered with the specimen (e.g., blue dye in the specimen, excessive foaming when shaken, smell of bleach), you must immediately conduct a new collection using direct observation procedures (see §40.67).
(2) In a case where a specimen is collected under direct observation because of showing signs of tampering, you must process both the original specimen and the specimen collected using direct observation and send the two sets of specimens to the laboratory. This is true even in a case in which the original specimen has insufficient volume but it shows signs of tampering. You must also, as soon as possible, inform the DER and collection site supervisor that a collection took place under direct observation and the reason for doing so.
(3) In a case where the employee refuses to provide a specimen under direct observation (see §40.191(a)(4)), you must discard any specimen the employee provided previously during the collection procedure. Then you must notify the DER as soon as practicable.
(a) As an employer, you must direct an immediate collection under direct observation with no advance notice to the employee, if:
(1) The laboratory reported to the MRO that a specimen is invalid, and the MRO reported to you that there was not an adequate medical explanation for the result;
(2) The MRO reported to you that the original positive, adulterated, or substituted result had to be cancelled because the test of the split specimen could not be performed; or
(3) The laboratory reported to the MRO that the specimen was negative-dilute with a creatinine concentration greater than or equal to 2 mg/dL but less than or equal to 5 mg/dL, and the MRO reported the specimen to you as negative-dilute and that a second collection must take place under direct observation (see §40.197(b)(1)).
(b) As an employer, you must direct a collection under direct observation of an employee if the drug test is a return-to-duty test or a follow-up test.
(c) As a collector, you must immediately conduct a collection under direct observation if:
(1) You are directed by the DER to do so (see paragraphs (a) and (b) of this section); or
(2) You observed materials brought to the collection site or the employee’s conduct clearly indicates an attempt to tamper with a specimen (see §§40.61(f)(5)(i) and 40.63(e)); or
(3) The temperature on the original specimen was out of range (see §40.65(b)(5)); or (4) The original specimen appeared to have been tampered with (see §40.65(c)(1)).
(d)(1) As the employer, you must explain to the employee the reason for a directly observed collection under paragraph (a) or (b) of this section.
(2) As the collector, you must explain to the employee the reason, if known, under this part for a directly observed collection under paragraphs (c)(1) through (3) of this section.
(e) As the collector, you must complete a new CCF for the directly observed collection.
(1) You must mark the “reason for test” block (Step 1) the same as for the first collection.
(2) You must check the “Observed, (Enter Remark)” box and enter the reason (see §40.67(b)) in the “Remarks” line (Step 2).
(f) In a case where two sets of specimens are being sent to the laboratory because of suspected tampering with the specimen at the collection site, enter on the “Remarks” line of the CCF (Step 2) for each specimen a notation to this effect (e.g., collection 1 of 2, or 2 of 2) and the specimen ID number of the other specimen.
(g) As the collector, you must ensure that the observer is the same gender as the employee. You must never permit an opposite gender person to act as the observer. The observer can be a different person from the collector and need not be a qualified collector.
(h) As the collector, if someone else is to observe the collection (e.g., in order to ensure a same gender observer), you must verbally instruct that person to follow procedures at paragraphs (i) and (j) of this section. If you, the collector, are the observer, you too must follow these procedures.
(i) As the observer, you must request the employee to raise his or her shirt, blouse, or dress/skirt, as appropriate, above the waist; and lower clothing and underpants to show you, by turning around, that they do not have a prosthetic device. After you have determined that the employee does not have such a device, you may permit the employee to return clothing to its proper position for observed urination.
(j) As the observer, you must watch the employee urinate into the collection container. Specifically, you are to watch the urine go from the employee’s body into the collection container.
(k) As the observer but not the collector, you must not take the collection container from the employee, but you must observe the specimen as the employee takes it to the collector.
(l) As the collector, when someone else has acted as the observer, you must include the observer’s name in the “Remarks” line of the CCF (Step 2).
(m) As the employee, if you decline to allow a directly observed collection required or permitted under this section to occur, this is a refusal to test.
(n) As a service agent, when you learn that a directly observed collection should have been collected but was not, you must inform the employer that it must direct the employee to have an immediate recollection under direct observation.
(a) As the collector, you must secure the room being used for the monitored collection so that no one except the employee and the monitor can enter it until after the collection has been completed.
(b) As the collector, you must ensure that the monitor is the same gender as the employee, unless the monitor is a medical professional (e.g., nurse, doctor, physician’s assistant, technologist, or technician licensed or certified to practice in the jurisdiction in which the collection takes place). The monitor can be a different person from the collector and need not be a qualified collector.
(c) As the collector, if someone else is to monitor the collection (e.g., in order to ensure a same-gender monitor), you must verbally instruct that person to follow the procedures of paragraphs (d) and (e) of this section. If you, the collector, are the monitor, you must follow these procedures.
(d) As the monitor, you must not watch the employee urinate into the collection container. If you hear sounds or make other observations indicating an attempt to tamper with a specimen, there must be an additional collection under direct observation (see §§40.63(e), 40.65(c), and 40.67(b)).
(e) As the monitor, you must ensure that the employee takes the collection container directly to the collector as soon as the employee has exited the enclosure.
(f) As the collector, when someone else has acted as the monitor, you must note that person’s name in the “Remarks” line of the CCF (Step 2).
(g) As the employee being tested, if you decline to permit a collection authorized under this section to be monitored, it is a refusal to test.
(a) All collections under DOT agency drug testing regulations must be split specimen collections.
(b) As the collector, you must take the following steps, in order, after the employee brings the urine specimen to you. You must take these steps in the presence of the employee.
(1) Check the box on the CCF (Step 2) indicating that this was a split specimen collection.
(2) You, not the employee, must first pour at least 30 mL of urine from the collection container into one specimen bottle, to be used for the primary specimen.
(3) You, not the employee, must then pour at least 15 mL of urine from the collection container into the second specimen bottle to be used for the split specimen.
(4) You, not the employee, must place and secure (i.e., tighten or snap) the lids/caps on the bottles.
(5) You, not the employee, must seal the bottles by placing the tamper-evident bottle seals over the bottle caps/lids and down the sides of the bottles.
(6) You, not the employee, must then write the date on the tamper-evident bottle seals.
(7) You must then ensure that the employee initials the tamper-evident bottle seals for the purpose of certifying that the bottles contain the specimens he or she provided. If the employee fails or refuses to do so, you must note this in the “Remarks” line of the CCF (Step 2) and complete the collection process.
(8) You must discard any urine left over in the collection container after both specimen bottles have been appropriately filled and sealed. There is one exception to this requirement: you may use excess urine to conduct clinical tests (e.g., protein, glucose) if the collection was conducted in conjunction with a physical examination required by a DOT agency regulation. Neither you nor anyone else may conduct further testing (such as adulteration testing) on this excess urine and the employee has no legal right to demand that the excess urine be turned over to the employee.
(a) As the collector, when using the paper CCF, you must do the following things to complete the collection process. You must complete the steps called for in paragraphs (a)(1) through (7) of this section in the employee’s presence.
(1) Direct the employee to read and sign the certification statement on Copy 2 (Step 5) of the CCF and provide date of birth, printed name, and day and evening contact telephone numbers. If the employee refuses to sign the CCF or to provide date of birth, printed name, or telephone numbers, you must note this in the “Remarks” line (Step 2) of the CCF, and complete the collection. If the employee refuses to fill out any information, you must, as a minimum, print the employee’s name in the appropriate place.
(2) Complete the chain of custody on the CCF (Step 4) by printing your name (note: you may pre-print your name), recording the time and date of the collection, signing the statement, and entering the name of the delivery service transferring the specimen to the laboratory,
(3) Ensure that all copies of the CCF are legible and complete.
(4) Remove Copy 5 of the CCF and give it to the employee.
(5) Place the specimen bottles and Copy 1 of the CCF in the appropriate pouches of the plastic bag.
(6) Secure both pouches of the plastic bag.
(7) Advise the employee that he or she may leave the collection site.
(8) To prepare the sealed plastic bag containing the specimens and CCF for shipment you must:
(i) Place the sealed plastic bag in a shipping container (e.g., standard courier box) designed to minimize the possibility of damage during shipment. (More than one sealed plastic bag can be placed into a single shipping container if you are doing multiple collections.)
(ii) Seal the container as appropriate.
(iii) If a laboratory courier hand-delivers the specimens from the collection site to the laboratory, prepare the sealed plastic bag for shipment as directed by the courier service.
(9) Send Copy 2 of the CCF to the MRO and Copy 4 to the DER. You must fax or otherwise transmit these copies to the MRO and DER within 24 hours or during the next business day. Keep Copy 3 for at least 30 days, unless otherwise specified by applicable DOT agency regulations.
(b) As a collector, when using other forms of the CCF as approved by the Office of Management and Budget, you must follow the procedures approved for that form.
(c) As a collector or collection site, you must ensure that each specimen you collect is shipped to a laboratory as quickly as possible, but in any case, within 24 hours or during the next business day.
(a) As a drug testing laboratory located in the U.S., you are permitted to participate in DOT drug testing only if you are certified by HHS under the National Laboratory Certification Program (NLCP) for all testing required under this part.
(b) As a drug testing laboratory located in Canada or Mexico which is not certified by HHS under the NLCP, you are permitted to participate in DOT drug testing only if:
(1) The DOT, based on a written recommendation from HHS, has approved your laboratory as meeting HHS laboratory certification standards or deemed your laboratory fully equivalent to a laboratory meeting HHS laboratory certification standards for all testing required under this part; or
(2) The DOT, based on a written recommendation from HHS, has recognized a Canadian or Mexican certifying organization as having equivalent laboratory certification standards and procedures to those of HHS, and the Canadian or Mexican certifying organization has certified your laboratory under those equivalent standards and procedures.
(c) As a laboratory participating in the DOT drug testing program, you must comply with the requirements of this part. You must also comply with all applicable requirements of HHS in testing DOT specimens, whether or not the HHS requirements are explicitly stated in this part.
(d) If DOT determines that you are in noncompliance with this part, you could be subject to PIE proceedings under Subpart R of this part. If the Department issues a PIE with respect to you, you are ineligible to participate in the DOT drug testing program even if you continue to meet the requirements of paragraph (a) or (b) of this section.
As the laboratory, you must do the following when you receive a DOT specimen:
(a) You are authorized to receive only Copy 1 of the CCF. You are not authorized to receive other copies of the CCF or any copies of the alcohol testing form.
(b) You must comply with applicable provisions of the HHS Guidelines concerning accessioning and processing urine drug specimens.
(c) You must inspect each specimen and CCF for the following “fatal flaws”:
(1) There is no CCF;
(2) In cases where a specimen has been collected, there is no specimen submitted with the CCF;
(3) There is no printed collector’s name and no collector’s signature;
(4) Two separate collections are performed using one CCF;
(5) The specimen ID numbers on the specimen bottle and the CCF do not match;
(6) The specimen bottle seal is broken or shows evidence of tampering, unless a split specimen can be redesignated (see paragraph (h) of this section);
(7) There is an insufficient amount of urine in the primary bottle for analysis, unless the specimens can be redesignated (see paragraph (h) of this section).
(d) When you find a specimen meeting the criteria of paragraph (c) of this section, you must document your findings and stop the testing process. Report the result in accordance with §40.97(a)(3) .
(e) You must inspect each CCF for the presence of the collector’s signature on the certification statement in Step 4 of the CCF. Upon finding that the signature is omitted, document the flaw and continue the testing process.
(1) In such a case, you must retain the specimen for a minimum of 5 business days from the date on which you initiated action to correct the flaw.
(2) You must then attempt to correct the flaw by following the procedures of §40.205(b)(1).
(3) If the flaw is not corrected, report the result as rejected for testing in accordance with §40.97(a)(3).
(f) If you determine that the specimen temperature was not checked and the “Remarks” line did not contain an entry regarding the temperature being outside of range, you must then attempt to correct the problem by following the procedures of §40.208.
(1) In such a case, you must continue your efforts to correct the problem for five business days, before you report the result.
(2) When you have obtained the correction, or five business days have elapsed, report the result in accordance with §40.97(a).
(g) If you determine that a CCF that fails to meet the requirements of §40.45(a) (e.g., a non-Federal form or an expired Federal form was used for the collection), you must attempt to correct the use of the improper form by following the procedures of §40.205(b)(2).
(1) In such a case, you must retain the specimen for a minimum of 5 business days from the date on which you initiated action to correct the problem.
(2) If the problem(s) is not corrected, you must reject the test and report the result in accordance with §40.97(a)(3).
(h) If the CCF is marked indicating that a split specimen collection was collected and if the split specimen does not accompany the primary, has leaked, or is otherwise unavailable for testing, you must still test the primary specimen and follow appropriate procedures outlined in §40.175(b) regarding the unavailability of the split specimen for testing.
(1) The primary specimen and the split specimen can be redesignated (i.e., Bottle B is redesignated as Bottle A, and vice-versa) if:
(i) The primary specimen appears to have leaked out of its sealed bottle and the laboratory believes a sufficient amount of urine exists in the split specimen to conduct all appropriate primary laboratory testing; or
(ii) The primary specimen is labeled as Bottle B, and the split specimen as Bottle A; or
(iii) The laboratory opens the split specimen instead of the primary specimen, the primary specimen remains sealed, and the laboratory believes a sufficient amount of urine exists in the split specimen to conduct all appropriate primary laboratory testing; or
(iv) The primary specimen seal is broken but the split specimen remains sealed and the laboratory believes a sufficient amount of urine exists in the split specimen to conduct all appropriate primary laboratory testing.
(2) In situations outlined in paragraph (g)(1) of this section, the laboratory shall mark through the “A” and write “B,” then initial and date the change. A corresponding change shall be made to the other bottle by marking through the “B” and writing “A,” and initialing and dating the change.
(i) A notation shall be made on Copy 1 of the CCF (Step 5a) and on any laboratory internal chain of custody documents, as appropriate, for any fatal or correctable flaw
As a laboratory, you must test for the following five drugs or classes of drugs in a DOT drug test. You must not test “DOT specimens” for any other drugs.
(a) Marijuana metabolites.
(b) Cocaine metabolites.
(e) Phencyclidine (PCP).
(a) As a laboratory, you must use the cutoff concentrations displayed in the following table for initial and confirmatory drug tests. All cutoff concentrations are expressed in nanograms per milliliter (ng/mL). The table follows:
|Initial test analyte||Initial test cutoff1||Confirmatory test analyte||Confirmatory test cutoff concentration|
|Marijuana metabolites (THCA)2||50 ng/mL3||THCA||15 ng/mL.|
|Cocaine metabolite (Benzoylecgonine)||150 ng/mL3||Benzoylecgonine||100 ng/mL.|
|6-Acetylmorphine||10 ng/mL||6-Acetylmorphine||10 ng/mL.|
|Phencyclidine||25 ng/mL||Phencyclidine||25 ng/mL.|
1For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial test cutoff):
Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The cross-reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the analytes within the group.
Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending on the technology. At least one analyte within the group must have a concentration equal to or greater than the initial test cutoff or, alternatively, the sum of the analytes present (i.e., equal to or greater than the laboratory’s validated limit of quantification) must be equal to or greater than the initial test cutoff.
2An immunoassay must be calibrated with the target analyte, Δ-9-tetrahydrocannabinol-9-carboxylic acid (THCA).
3Alternate technology (THCA and Benzoylecgonine): When using an alternate technology initial test for the specific target analytes of THCA and Benzoylecgonine, the laboratory must use the same cutoff for the initial and confirmatory tests (i.e., 15 ng/mL for THCA and 100ng/mL for Benzoylecgonine).
(b) On an initial drug test, you must report a result below the cutoff concentration as negative. If the result is at or above the cutoff concentration, you must conduct a confirmation test.
(c) On a confirmation drug test, you must report a result below the cutoff concentration as negative and a result at or above the cutoff concentration as confirmed positive.
(d) You must report quantitative values for morphine or codeine at 15,000 ng/mL or above.
(a) Specimen validity testing is the evaluation of the specimen to determine if it is consistent with normal human urine.The purpose of validity testing is to determine whether certain adulterants or foreign substances were added to the urine, if the urine was diluted, or if the specimen was substituted.
(b) As a laboratory, you must conduct validity testing.