49 CFR Part 40 – DOT Procedures (continued)

Subpart A – Administrative Provisions

40.1 Who does this regulation cover?
(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).

§40.3 What do the terms used in this regulation mean?
In this part, the terms listed in this section have the following meanings:

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

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 placed on a conforming products list (CPL) for such devices.

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.

Blind specimen or blind performance test specimen. A specimen submitted to a laboratory for quality control testing purposes, with a fictitious identifier, so that the laboratory cannot distinguish it from an employee 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).
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.

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

Confirmed drug test. A confirmation test result received by an MRO from a laboratory.
Consortium/ Third-party administrator (C/TPA). A service agent that provides or coordinates the provision of a variety of drug and alcohol testing services to employers. C/TPAs typically perform administrative tasks concerning the operation of the employers’ drug and alcohol testing programs. 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 medical review officers (MROs) and substance abuse professionals (SAPs) who have completed qualification training and are performing MRO or SAP functions, designed to keep MROs and SAPs current on changes and developments in the DOT drug and alcohol testing program.

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 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 United States Coast Guard (USCG), the Federal Aviation Administration (FAA), the Federal Railroad Administration (FRA), the Federal Motor Carrier Safety Administration (FMCSA), the Federal Transit Administration (FTA), the National Highway Traffic Safety Administration (NHTSA), the Research and Special Programs Administration (RSPA), and the Office of the Secretary (OST). These terms include any designee of a DOT agency.

Drugs. The drugs for which tests are required under this part and DOT agency regulations are marijuana, cocaine, amphetamines, phencyclidine (PCP), and opiates.
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 approved by NHTSA for the evidential testing of breath at the .02 and .04 alcohol concentrations, placed on NHTSA’s Conforming Products List (CPL) for “Evidential Breath Measurement Devices” and identified on the CPL as conforming with the model specifications available from NHTSA’s Traffic Safety Program.

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

Initial drug test. The test used to differentiate a negative specimen from one that requires further testing for drugs or drug metabolites.

Initial validity test. The first test used to determine if a specimen is adulterated, diluted, or substituted.

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

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. (The HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs are available on the internet at http://www.health.org/workpl.htm or from the Division of Workplace Programs, 5600 Fishers Lane, Rockwall II Building, Suite 815, Rockville, MD 20857.)

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.

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.

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.

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).

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).

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 specified under this part 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 the qualifications set forth in applicable sections of this part. 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.

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

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

§40.5 Who issues authoritative interpretations of this regulation?
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.

§40.7 How can you get an exemption from a requirement in this regulation?
(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
400 7th Street, SW., Room 10424
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.

Subpart B – Employer Responsibilities
§40.11 What are the general responsibilities of employers under this regulation?
(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.

§40.13 How do DOT drug and alcohol tests relate to non-DOT tests?
(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.

§40.15 May an employer use a service agent to meet DOT drug and alcohol testing requirements?
(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.

§40.17 Is an employer responsible for obtaining information from its service agents?
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.

§40.19 [Reserved]

§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.

§40.23 What actions do employers take after receiving verified test results?
(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 – 0.39, 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 specimen 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) as for the original collection.
(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 indemnifica- tion 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).

§40.29 Where is other information on employer responsibilities found in this regulation?
You can find other information on the responsibilities of employers in the following sections of this part:
§40.3 – definition.
§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.
§§40.103 – 40.105 – blind specimen requirements.
§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.

Subpart C – Urine Collection Personnel
§40.31 Who may collect urine specimens for DOT drug testing?
(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.

§40.33 What training requirements must a collector meet?
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, and you must keep current on any changes to these materials. The DOT Urine Specimen Collection Procedures Guidelines document is available from ODAPC (Department of Transportation, 400 7th Street, S.W., Room 10403, Washington DC, 20590, 202-366-3784, or on the ODAPC web site (http://www.dot.gov/ost/dapc).
(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) Schedule for qualification training and initial proficiency demonstration. The following is the schedule for qualification training and the initial proficiency demonstration you must meet:
(1) If you became a collector before August 1, 2001, and you have already met the requirements of paragraphs (b) and (c) of this section, you do not have to meet them again.
(2) If you became a collector before August 1, 2001, and have yet to meet the requirements of paragraphs (b) and (c) of this section, you must do so no later than January 31, 2003.
(3) If you become a collector on or after August 1, 2001, 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.
(i) 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.
(ii) 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.
(iii) 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.

§40.35 What information about the DER must employers provide to collectors?
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.

§40.37 Where is other information on the role of collectors found in this regulation?
You can find other information on the role and functions of collectors in the following sections of this part:
§40.3 – definition.
§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.
§40.103 – processing blind specimens.
§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.

Subpart D – Collection Sites, Forms, Equipment and Supplies Used in DOT Urine Collections
§40.41 Where does a urine collection for a DOT drug test take place?
(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.

§40.45 What form is used to document a DOT urine collection?
(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. The CCF must be a five-part carbonless manifold form. You may view this form on the Department’s web site (http://www.dot.gov/ost/dapc) or the HHS web site (http://www.workplace.samhsa.gov).
(b) You must not use a non-Federal form or an expired Federal form 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 Federal form to these participants. You must also affirmatively notify these participants that they must not use an expired Federal form (e.g., that beginning August 1, 2001, they may not use the old 7-part Federal CCF for DOT urine collections).
(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, you may add the name of the DOT agency under whose authority the test occurred as part of the employer information.
(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.
(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.

§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).

§40.49 What materials are used to collect urine specimens?
For each DOT drug test, you must use a collection kit meeting the requirements of Appendix A of this part.

§40.51 What materials are used to send urine specimens to the laboratory?
(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.

Subpart E – Urine Specimen Collections
§40.61 What are the preliminary steps in the collection process?
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 note the conduct and the fact that the collection was observed in the “Remarks” line of the CCF (Step 2). 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.

§40.65 What does the collector check for when the employee presents a specimen?
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 º C / 90-100 º 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.

§40.67 When and how is a directly observed collection conducted?
(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; or
(2) The MRO reported to you that the original positive, adulterated, or substituted test result had to be cancelled because the test of the split specimen could not be performed.
(b) As an employer, you may 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 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.
(j) 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.
(k) 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).
(l) 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.
(m) As the collector, 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.

§40.69 How is a monitored collection conducted?
(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.

§40.71 How does the collector prepare the specimens?
(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.

§40.73 How is the collection process completed?
(a) As the collector, you must do the following things to complete the collection process. You must complete the steps called for in paragraphs (a)(1) through (a)(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 5) 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 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.

Subpart F – Drug Testing Laboratories
§40.81 What laboratories may be used for DOT drug testing?
(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 Departmentissues 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.

§40.83 How do laboratories process incoming specimens?
As the laboratory, you must do the following when you receive a DOT specimen:
(a) You are authorized to receive only the laboratory copy of the CCF. You are not authorized to receive other copies of the CCF nor 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) The specimen ID numbers on the specimen bottle and the CCF do not match;
(2) The specimen bottle seal is broken or shows evidence of tampering, unless a split specimen can be redesignated (see paragraph (g) of this section);
(3) The collector’s printed name and signature are omitted from the CCF; and
(4) There is an insufficient amount of urine in the primary bottle for analysis, unless the specimens can be redesignated (see paragraph (g) 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) During the period August 1 – October 31, 2001, you are not required to reject a test conducted on an expired Federal CCF because this problem is not corrected. Beginning November 1, 2001, 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.

§40.85 What drugs do laboratories test for?
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.
(c) Amphetamines.
(d) Opiate metabolites.
(e) Phencyclidine (PCP).

§40.87 What are the cutoff concentrations for initial and confirmation tests?
(a) As a laboratory, you must use the cutoff concentrations displayed in the following table for initial and confirmation drug tests. All cutoff concentrations are expressed in nanograms per milliliter (ng/mL). The table follows:

Type of Drug or
Metabolite Initial Test Confirmation Test
(1) (1) Marijuana metabolites

(i) Delta-9-tetrahydrocanna-
binol -9-carboxylic acid
(THC) 50

15
(2) (2) Cocaine metabolites
(Benzoylecgonine) 300 150
(3) (3) Phencyclidine (PCP) 25 25
(4) (4) Amphetamines

(i) Amphetamine

(ii) Methamphetamine 1000

500
500 (S Specimen must also
contain amphetamine
at a concentration of
greater than or equal to
200 ng/mL.

2000

10
(T Test for 6-AM in the
specimen. Conduct this
test only when specimen
contains morphine at a
concentration greater than
or equal to 2000 ng/mL.

(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.

§40.89 What is validity testing, and are laboratories required to conduct it?
(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 are authorized to conduct validity testing.

§40.91 What validity tests must laboratories conduct on primary specimens?
As a laboratory, when you conduct validity testing under §40.89, you must conduct it in accordance with the requirements of this section.
(a) You must test each primary specimen for creatinine. You must also determine its specific gravity if you find that the creatinine concentration is less than 20 mg/dL.
(b) You must measure the pH of each primary specimen.
(c) You must test each primary specimen to determine if it contains substances that may be used to adulterate the specimen. Your tests must have the capability of determining whether any substance identified in current HHS requirements or specimen validity guidance is present in the specimen.
(d) If you suspect the presence of an interfering substance/adulterant that could make a test result invalid, but you are unable to identify it (e.g., a new adulterant), you must, as the first laboratory, send the specimen to another HHS certified laboratory that has the capability of doing so.
(e) If you identify a substance in a specimen that appears to be an adulterant, but which is not listed in current HHS requirements or guidance, you must report the finding in writing to ODAPC and the Division of Workplace Programs, HHS, within three business days. You must also complete testing of the specimen for drugs, to the extent technically feasible.
(f) You must conserve as much as possible of the specimen for possible future testing.

§40.93 What criteria do laboratories use to establish that a specimen is dilute or substituted?
(a) As a laboratory you must consider the primary specimen to be dilute if the creatinine concentration is less than 20 mg/dL and the specific gravity is less than 1.003, unless the criteria for a substituted specimen are met.
(b) As a laboratory you must consider the primary specimen to be substituted if the creatinine concentration is less than or equal to 5 mg/dL and the specific gravity is less than or equal to 1.001 or greater than or equal to 1.020.

§40.95 What criteria do laboratories use to establish that a specimen is adulterated?
(a) As a laboratory, you must consider the primary specimen to be adulterated if you determine that –
(1) A substance that is not expected to be present in human urine is identified in the specimen;
(2) A substance that is expected to be present in human urine is identified at a concentration so high that it is not consistent with human urine; or
(3) The physical characteristics of the specimen are outside the normal expected range for human urine.
(b) In making your determination under paragraph (a) of this section, you must apply the criteria in current HHS requirements or specimen validity guidance.

§40.97 What do laboratories report and how do they report it?
(a) As a laboratory, you must report the results for each primary specimen tested as one or more of the following:
(1) Negative;
(2) Negative – dilute;
(3) Rejected for testing, with remark(s);
(4) Positive, with drug(s)/metabolite(s) noted;
(5) Positive, with drug(s)/metabolite(s) noted – dilute;
(6) Adulterated, with remark(s);
(7) Substituted, with remark(s); or
(8) Invalid result, with remark(s).
(b) As a laboratory, you must report laboratory results directly, and only, to the MRO at his or her place of business. You must not report results to or through the DER or a service agent (e.g., C/TPA).
(1) Negative results: You must fax, courier, mail, or electronically transmit a legible image or copy of the fully-completed Copy 1 of the CCF which has been signed by the certifying scientist, or you may provide the laboratory results report electronically (i.e., computer data file).
(i) If you elect to provide the laboratory results report, you must include the following elements, as a minimum, in the report format:
(A) Laboratory name and address;
(B) Employer’s name (you may include I.D. or account number);
(C) Medical review officer’s name;
(D) Specimen I.D. number;
(E) Donor’s SSN or employee I.D. number, if provided;
(F) Reason for test, if provided;
(G) Collector’s name and telephone number;
(H) Date of the collection;
(I) Date received at the laboratory;
(J) Date certifying scientist released the results;
(K) Certifying scientist’s name;
(L) Results (e.g., positive, adulterated) as listed in paragraph (a) of this section; and
(M) Remarks section, with an explanation of any situation in which a correctable flaw has been corrected.
(ii) You may release the laboratory results report only after review and approval by the certifying scientist. It must reflect the same test result information as contained on the CCF signed by the certifying scientist. The information contained in the laboratory results report may not contain information that does not appear on the CCF.
(iii) The results report may be transmitted through any means that ensures accuracy and confidentiality. You, as the laboratory, together with the MRO, must ensure that the information is adequately protected from unauthorized access or release, both during transmission and in storage.
(2) Non-negative results: You must fax, courier, mail, or electronically transmit a legible image or copy of the fully-completed Copy 1 of the CCF that has been signed by the certifying scientist. In addition, you may provide the electronic laboratory results report following the format and procedures set forth in paragraphs (b)(1)(i) and (ii) of this section.
(c) In transmitting laboratory results to the MRO, you, as the laboratory, together with the MRO, must ensure that the information is adequately protected from unauthorized access or release, both during transmission and in storage. If the results are provided by fax, the fax connection must have a fixed telephone number accessible only to authorized individuals.
(d) You must transmit test results to the MRO in a timely manner, preferably the same day that review by the certifying scientist is completed.
(e) You must provide quantitative values for confirmed positive drug, adulterated, and substituted test results to the MRO when the MRO requests you to do so in writing. The MRO’s request may either be a general request covering all such results you send to the MRO or a specific case-by-case request.
(f) You must provide quantitative values for confirmed opiate results for morphine or codeine at 15,000 ng/mL or above, even if the MRO has not requested quantitative values for the test result.

§40.99 How long does the laboratory retain specimens after testing?
(a) As a laboratory testing the primary specimen, you must retain a specimen that was reported with positive, adulterated, substituted, or invalid results for a minimum of one year.
(b) You must keep such a specimen in secure, long-term, frozen storage in accordance with HHS requirements.
(c) Within the one-year period, the MRO, the employee, the employer, or a DOT agency may request in writing that you retain a specimen for an additional period of time (e.g., for the purpose of preserving evidence for litigation or a safety investigation). If you receive such a request, you must comply with it. If you do not receive such a request, you may discard the specimen at the end of the year.
(d) If you have not sent the split specimen to another laboratory for testing, you must retain the split specimen for an employee’s test for the same period of time that you retain the primary specimen and under the same storage conditions.
(e) As the laboratory testing the split specimen, you must meet the requirements of paragraphs (a) through (d) of this section with respect to the split specimen.

§40.101 What relationship may a laboratory have with an MRO?
(a) As a laboratory, you may not enter into any relationship with an MRO that creates a conflict of interest or the appearance of a conflict of interest with the MRO’s responsibilities for the employer. You may not derive any financial benefit by having an employer use a specific MRO.
(b) The following are examples of relationships between laboratories and MROs that the Department regards as creating conflicts of interest, or the appearance of such conflicts. This following list of examples is not intended to be exclusive or exhaustive:
(1) The laboratory employs an MRO who reviews test results produced by the laboratory;
(2) The laboratory has a contract or retainer with the MRO for the review of test results produced by the laboratory;
(3) The laboratory designates which MRO the employer is to use, gives the employer a slate of MROs from which to choose, or recommends certain MROs;
(4) The laboratory gives the employer a discount or other incentive to use a particular MRO;
(5) The laboratory has its place of business co-located with that of an MRO or MRO staff who review test results produced by the laboratory; or
(6) The laboratory permits an MRO, or an MRO’s organization, to have a financial interest in the laboratory.

§40.103 What are the requirements for submitting blind specimens to a laboratory?
(a) As an employer or C/TPA with an aggregate of 2000 or more DOT-covered employees, you must send blind specimens to laboratories you use. If you have an aggregate of fewer than 2000 DOT-covered employees, you are not required to provide blind specimens.
(b) To each laboratory to which you send at least 100 specimens in a year, you must transmit a number of blind specimens equivalent to one percent of the specimens you send to that laboratory, up to a maximum of 50 blind specimens in each quarter (i.e., January-March, April-June, July-September, October-December). As a C/TPA, you must apply this percentage to the total number of DOT-covered employees’ specimens you send to the laboratory. Your blind specimen submissions must be evenly spread throughout the year. The following examples illustrate how this requirement works:
Example 1 to Paragraph (b). You send 2500 specimens to Lab X in Year 1. In this case, you would send 25 blind specimens to Lab X in Year 1. To meet the even distribution requirement, you would send 6 in each of three quarters and 7 in the other.
Example 2 to Paragraph (b) . You send 2000 specimens to Lab X and 1000 specimens to Lab Y in Year 1. In this case, you would send 20 blind specimens to Lab X and 10 to Lab Y in Year 1. The even distribution requirement would apply in a similar way to that described in Example 1.
Example 3 to Paragraph (b). Same as Example 2, except that you also send 20 specimens to Lab Z. In this case, you would send blind specimens to Labs X and Y as in Example 2. You would not have to send any blind specimens to Lab Z, because you sent fewer than 100 specimens to Lab Z.
Example 4 to Paragraph (b). You are a C/TPA sending 2000 specimens to Lab X in Year 1. These 2000 specimens represent 200 small employers who have an average of 10 covered employees each. In this case you – not the individual employers – send 20 blind specimens to Lab X in Year 1, again ensuring even distribution. The individual employers you represent are not required to provide any blind specimens on their own.
Example 5 to Paragraph (b). You are a large C/TPA that sends 40,000 specimens to Lab Y in Year 1. One percent of that figure is 400. However, the 50 blind specimen per quarter “cap” means that you need send only 50 blind specimens per quarter, rather than the 100 per quarter you would have to send to meet the one percent rate. Your annual total would be 200, rather than 400, blind specimens.
(c) Approximately 75 percent of the specimens you submit must be blank (i.e., containing no drugs, nor adulterated or substituted). Approximately 15 percent must be positive for one or more of the five drugs involved in DOT tests, and approximately 10 percent must either be adulterated with a substance cited in HHS guidance or substituted (i.e., having specific gravity and creatinine meeting the criteria of §40.93(b)).
(1) The blind specimens that you submit that contain drugs, that are adulterated with a substance cited in HHS guidance, or that are substituted must be validated as to their contents by the supplier using initial and confirmatory tests.
(2) The supplier must provide information regarding the shelf life of the blind specimens.
(3) If the blind specimen is drug positive, the concentration of drug it contains must be between 1.5 and 2 times the initial drug test cutoff concentration.
(4) If the blind specimen is adulterated with nitrite, the concentration of nitrite it contains must be between 1.5 and 2 times the initial validity test cutoff concentration.
(5) If the blind specimen is adulterated by altering pH, the pH must be less than or equal to 2, or greater than or equal to 12.
(6) If the blind specimen is substituted, the creatinine must be less than or equal to 2, and the specific gravity must be 1.000.
(d) You must ensure that each blind specimen is indistinguishable to the laboratory from a normal specimen.
(1) You must submit blind specimens to the laboratory using the same channels (e.g., via a regular collection site) through which employees’ specimens are sent to the laboratory.
(2) You must ensure that the collector uses a CCF, places fictional initials on the specimen bottle label/seal, indicates for the MRO on Copy 2 that the specimen is a blind specimen, and discards Copies 4 and 5 (employer and employee copies).
(3) You must ensure that all blind specimens include split specimens.

§40.105 What happens if the laboratory reports a result different from that expected for a blind specimen?
(a) If you are an employer, MRO, or C/TPA who submits a blind specimen, and if the result reported to the MRO is different from the result expected, you must investigate the discrepancy.
(b) If the unexpected result is a false negative, you must provide the laboratory with the expected results (obtained from the supplier of the blind specimen), and direct the laboratory to determine the reason for the discrepancy.
(c) If the unexpected result is a false positive, you must provide the laboratory with the expected results (obtained from the supplier of the blind specimen), and direct the laboratory to determine the reason for the discrepancy. You must also notify ODAPC of the discrepancy by telephone (202-366-3784) or e-mail (addresses are listed on the ODAPC web site, http://www.dot.gov/ost/dapc). ODAPC will notify HHS who will take appropriate action.

§40.107 Who may inspect laboratories?
As a laboratory, you must permit an inspection, with or without prior notice, by ODAPC, a DOT agency, or a DOT-regulated employer that contracts with the laboratory for drug testing under the DOT drug testing program, or the designee of such an employer.

§40.109 What documentation must the laboratory keep, and for how long?
(a) As a laboratory, you must retain all records pertaining to each employee urine specimen for a minimum of two years.
(b) As a laboratory, you must also keep for two years employer-specific data required in §40.111 .
(c) Within the two-year period, the MRO, the employee, the employer, or a DOT agency may request in writing that you retain the records for an additional period of time (e.g., for the purpose of preserving evidence for litigation or a safety investigation). If you receive such a request, you must comply with it. If you do not receive such a request, you may discard the records at the end of the two-year period.

§40.111 When and how must a laboratory disclose statistical summaries and other information it maintains?
(a) As a laboratory, you must transmit an aggregate statistical summary, by employer, of the data listed in Appendix B to this part to the employer on a semi-annual basis.
(1) The summary must not reveal the identity of any employee.
(2) In order to avoid sending data from which it is likely that information about an employee’s test result can be readily inferred, you must not send a summary if the employer has fewer than five aggregate tests results.
(3) The summary must be sent by January 20 of each year for July 1 through December 31 of the prior year.
(4) The summary must also be sent by July 20 of each year for January 1 through June 30 of the current year.
(b) When the employer requests a summary in response to an inspection, audit, or review by a DOT agency, you must provide it unless the employer had fewer than five aggregate test results. In that case, you must send the employer a report indicating that not enough testing was conducted to warrant a summary. You may transmit the summary or report by hard copy, fax, or other electronic means.
(c) You must also release information to appropriate parties as provided in §§40.329 and 40.331.

§40.113 Where is other information concerning laboratories found in this regulation?
You can find more information concerning laboratories in several sections of this part:
§40.3 – definition.
§40.13 – prohibition on making specimens available for other purposes.
§40.31 – conflicts of interest concerning collectors.
§40.47 – laboratory rejections of test for improper form.
§40.125 – conflicts of interest concerning MROs.
§40.175 – role of first laboratory in split specimen tests.
§40.177 – role of second laboratory in split specimen tests (drugs).
§40.179 – role of second laboratory in split specimen tests (adulterants).
§40.181 – role of second laboratory in split specimen tests (substitution).
§§40.183 – 40.185 – transmission of split specimen test results to MRO.
§§40.201 – 40.205 – role in correcting errors.
§40.329 – release of information to employees.
§40.331 – limits on release of information.
§40.355 – role with respect to other service agents.

Subpart G – Medical Review Officers and the Verification Process
§40.121 Who is qualified to act as an MRO?
To be qualified to act as an MRO in the DOT drug testing program, you must meet each of the requirements of this section:
(a) Credentials. You must be a licensed physician (Doctor of Medicine or Osteopathy). If you are a licensed physician in any U.S., Canadian, or Mexican jurisdiction and meet the other requirements of this section, you are authorized to perform MRO services with respect to all covered employees, wherever they are located. For example, if you are licensed as an M.D. in one state or province in the U.S., Canada, or Mexico, you are not limited to performing MRO functions in that state or province, and you may perform MRO functions for employees in other states or provinces without becoming licensed to practice medicine in the other jurisdictions.
(b) Basic knowledge. You must be knowledgeable in the following areas:
(1) You must be knowledgeable about and have clinical experience in controlled substances abuse disorders, including detailed knowledge of alternative medical explanations for laboratory confirmed drug test results.
(2) You must be knowledgeable about issues relating to adulterated and substituted specimens as well as the possible medical causes of specimens having an invalid result.
(3) You must be knowledgeable about this part, the DOT MRO Guidelines, and the DOT agency regulations applicable to the employers for whom you evaluate drug test results, and you must keep current on any changes to these materials. The DOT MRO Guidelines document is available from ODAPC (Department of Transportation, 400 7th Street, SW., Room 10403, Washington DC, 20590, 202-366-3784, or on the ODAPC web site (http:// www.dot.gov / ost/dapc)).
(c) Qualification training. You must receive qualification training meeting the requirements of this paragraph (c).
(1) Qualification training must provide instruction on the following subjects:
(i) Collection procedures for urine specimens;
(ii) Chain of custody, reporting, and recordkeeping;
(iii) Interpretation of drug and validity tests results;
(iv) The role and responsibilities of the MRO in the DOT drug testing program;
(v) The interaction with other participants in the program (e.g., DERs, SAPs); and
(vi) Provisions of this part and DOT agency rules applying to employers for whom you review test results, including changes and updates to this part and DOT agency rules, guidance, interpretations, and policies affecting the performance of MRO functions, as well as issues that MROs confront in carrying out their duties under this part and DOT agency rules.
(2) Following your completion of qualification training under paragraph (c)(1) of this section, you must satisfactorily complete an examination administered by a nationally-recognized MRO certification board or subspecialty board for medical practitioners in the field of medical review of DOT-mandated drug tests. The examination must comprehensively cover all the elements of qualification training listed in paragraph (c) (1) of this section.
(3) The following is the schedule for qualification training you must meet:
(i) If you became an MRO before August 1, 2001, and have already met the qualification training requirement, you do not have to meet it again.
(ii) If you became an MRO before August 1, 2001, but have not yet met the qualification training requirement, you must do so no later than January 31, 2003.
(iii) If you become an MRO on or after August 1, 2001, you must meet the qualification training requirement before you begin to perform MRO functions.
(d) Continuing education. During each three-year period from the date on which you satisfactorily complete the examination under paragraph (c)(2) of this section, you must complete continuing education consisting of at least 12 professional development hours (e.g., Continuing Education Medical Units) relevant to performing MRO functions .
(1) This continuing education must include material concerning new technologies, interpretations, recent guidance, rule changes, and other information about developments in MRO practice, pertaining to the DOT program, since the time you met the qualification training requirements of this section.
(2) Your continuing education activities must include assessment tools to assist you in determining whether you have adequately learned the material.
(3) If you are an MRO who completed the qualification training and examination requirements prior to August 1, 2001, you must complete your first increment of 12 CEU hours before August 1, 2004.
(e) 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.

§40.123 What are the MRO’s responsibilities in the DOT drug testing program?
As an MRO, you have the following basic responsibilities:
(a) Acting as an independent and impartial “gatekeeper” and advocate for the accuracy and integrity of the drug testing process.
(b) Providing a quality assurance review of the drug testing process for the specimens under your purview. This includes, but is not limited to:
(1) Ensuring the review of the CCF on all specimen collections for the purposes of determining whether there is a problem that may cause a test to be cancelled (see §§40.199 – 40.203 ). As an MRO, you are not required to review laboratory internal chain of custody documentation. No one is permitted to cancel a test because you have not reviewed this documentation;
(2) Providing feedback to employers, collection sites and laboratories regarding performance issues where necessary; and
(3) Reporting to and consulting with the ODAPC or a relevant DOT agency when you wish DOT assistance in resolving any program issue. As an employer or service agent, you are prohibited from limiting or attempting to limit the MRO’s access to DOT for this purpose and from retaliating in any way against an MRO for discussing drug testing issues with DOT.
(c) You must determine whether there is a legitimate medical explanation for confirmed positive, adulterated, substituted, and invalid drug tests results from the laboratory.
(d) While you provide medical review of employees’ test results, this part does not deem that you have established a doctor-patient relationship with the employees whose tests you review.
(e) You must act to investigate and correct problems where possible and notify appropriate parties (e.g., HHS, DOT, employers, service agents) where assistance is needed, (e.g., cancelled or problematic tests, incorrect results, problems with blind specimens).
(f) You must ensure the timely flow of test results and other information to employers.
(g) You must protect the confidentiality of the drug testing information.
(h) You must perform all your functions in compliance with this part and other DOT agency regulations.

§40.125 What relationship may an MRO have with a laboratory?
As an MRO, you may not enter into any relationship with an employer’s laboratory that creates a conflict of interest or the appearance of a conflict of interest with your responsibilities to that employer. You may not derive any financial benefit by having an employer use a specific laboratory. For examples of relationships between laboratories and MROs that the Department views as creating a conflict of interest or the appearance of such a conflict, see §40.101(b) .

§40.127 What are the MRO’s functions in reviewing negative test results?
As the MRO, you must do the following with respect to negative drug test results you receive from a laboratory, prior to verifying the result and releasing it to the DER:
(a) Review Copy 2 of the CCF to determine if there are any fatal or correctable errors that may require you to initiate corrective action or to cancel the test (see §§40.199 and 40.203 ).
(b) Review the negative laboratory test result and ensure that it is consistent with the information contained on the CCF.
(c) Before you report a negative test result, you must have in your possession the following documents:
(1) Copy 2 of the CCF, a legible copy of it, or any other CCF copy containing the employee’s signature; and
(2) A legible copy (fax, photocopy, image) of Copy 1 of the CCF or the electronic laboratory results report that conveys the negative laboratory test result.
(d) If the copy of the documentation provided to you by the collector or laboratory appears unclear, you must request that the collector or laboratory send you a legible copy.
(e) On Copy 2 of the CCF, place a check mark in the “Negative” box (Step 6), provide your name, and sign, initial, or stamp and date the verification statement.
(f) Report the result in a confidential manner (see §§40.163 – 40.167 ).
(g) Staff under your direct, personal supervision may perform the administrative functions of this section for you, but only you can cancel a test. If you cancel a laboratory-confirmed negative result, check the “Test Cancelled’’ box (Step 6) on Copy 2 of the CCF, make appropriate annotation in the “Remarks” line, provide your name, and sign, initial or stamp and date the verification statement.
(1) On specimen results that are reviewed by your staff, you are responsible for assuring the quality of their work.
(2) You are required to personally review at least 5 percent of all CCFs reviewed by your staff on a quarterly basis, including all results that required a corrective action. However, you need not review more than 500 negative results in any quarter.
(3) Your review must, as a minimum, include the CCF, negative laboratory test result, any accompanying corrective documents, and the report sent to the employer. You must correct any errors that you discover. You must take action as necessary to ensure compliance by your staff with this part and document your corrective action. You must attest to the quality assurance review by initialing the CCFs that you review.
(4) You must make these CCFs easily identifiable and retrievable by you for review by DOT agencies.

§40.129 What are the MRO’s functions in reviewing laboratory confirmed positive, adulterated, substituted, or invalid drug test results?
(a) As the MRO, you must do the following with respect to confirmed positive, adulterated, substituted, or invalid drug tests you receive from a laboratory, before you verify the result and release it to the DER:
(1) Review Copy 2 of the CCF to determine if there are any fatal or correctable errors that may require you to cancel the test (see §§40.199 and 40.203 ). Staff under your direct, personal supervision may conduct this administrative review for you, but only you may verify or cancel a test.
(2) Review Copy 1 of the CCF and ensure that it is consistent with the information contained on Copy 2, that the test result is legible, and that the certifying scientist signed the form. You are not required to review any other documentation generated by the laboratory during their analysis or handling of the specimen (e.g., the laboratory internal chain of custody).
(3) If the copy of the documentation provided to you by the collector or laboratory appears unclear, you must request that the collector or laboratory send you a legible copy.
(4) Except in the circumstances spelled out in §40.133 , conduct a verification interview. This interview must include direct contact in person or by telephone between you and the employee. You may initiate the verification process based on the laboratory results report.
(5) Verify the test result as either negative, positive, test cancelled, or refusal to test because of adulteration or substitution, consistent with the requirements of §§40.135 — 40.145 and 40.159 .
(b) Before you report a verified negative, positive, test cancelled, refusal to test because of adulteration or substitution, you must have in your possession the following documents:
(1) Copy 2 of the CCF, a legible copy of it, or any other CCF copy containing the employee’s signature; and
(2) A legible copy (fax, photocopy, image) of Copy 1 of the CCF, containing the certifying scientist’s signature.
(c) With respect to verified positive test results, place a check mark in the “Positive” box (Step 6) on Copy 2 of the CCF, indicate the drug(s)/ metabolite(s) detected on the “Remarks” line, sign and date the verification statement.
(d) If you cancel a laboratory confirmed positive, adulterated, substituted, or invalid drug test report, check the “test cancelled” box (Step 6) on Copy 2 of the CCF, make appropriate annotation in the “Remarks” line, sign, provide your name, and date the verification statement.
(e) Report the result in a confidential manner (see §§40.163 – 40.167 ).
(f) With respect to adulteration or substitution test results, check the “refusal to test because:” box (Step 6) on Copy 2 of the CCF, check the “Adulterated” or “Substituted” box, as appropriate, make appropriate annotation in the “Remarks” line, sign and date the verification statement.
(g) As the MRO, your actions concerning reporting confirmed positive, adulterated, or substituted results to the employer before you have completed the verification process are also governed by the stand-down provisions of §40.21 .
(1) If an employer has a stand-down policy that meets the requirements of §40.21 , you may report to the DER that you have received an employee’s laboratory confirmed positive, adulterated, or substituted test result, consistent with the terms of the waiver the employer received. You must not provide any further details about the test result (e.g., the name of the drug involved).
(2) If the employer does not have a stand-down policy that meets the requirements of §40.21 , you must not inform the employer that you have received an employee’s laboratory confirmed positive, adulterated, or substituted test result until you verify the test result. For example, as an MRO employed directly by a company, you must not tell anyone on the company’s staff or management that you have received an employee’s laboratory confirmed test result.

§40.131 How does the MRO or DER notify an employee of the verification process after a confirmed positive, adulterated, substituted, or invalid test result?
(a) When, as the MRO, you receive a confirmed positive, adulterated, substituted, or invalid test result from the laboratory, you must contact the employee directly (i.e., actually talk to the employee), on a confidential basis, to determine whether the employee wants to discuss the test result. In making this contact, you must explain to the employee that, if he or she declines to discuss the result, you will verify the test as positive or as a refusal to test because of adulteration or substitution, as applicable.
(b) As the MRO, staff under your personal supervision may conduct this initial contact for you.
(1) This staff contact must be limited to scheduling the discussion between you and the employee and explaining the consequences of the employee’s declining to speak with you (i.e., that the MRO will verify the test without input from the employee). If the employee declines to speak with you, the staff person must document the employee’s decision, including the date and time.
(2) A staff person must not gather any medical information or information concerning possible explanations for the test result.
(3) A staff person may advise an employee to have medical information (e.g., prescriptions, information forming the basis of a legitimate medical explanation for a confirmed positive test result) ready to present at the interview with the MRO.
(4) Since you are required to speak personally with the employee, face-to-face or on the phone, your staff must not inquire if the employee wishes to speak with you.
(c) As the MRO, you or your staff must make reasonable efforts to reach the employee at the day and evening telephone numbers listed on the CCF. Reasonable efforts include, as a minimum, three attempts, spaced reasonably over a 24-hour period, to reach the employee at the day and evening telephone numbers listed on the CCF. If you or your staff cannot reach the employee directly after making these efforts, you or your staff must take the following steps:
(1) Document the efforts you made to contact the employee, including dates and times. If both phone numbers are incorrect (e.g., disconnected, wrong number), you may take the actions listed in paragraph (c)(2) of this section without waiting the full 24-hour period.
(2) Contact the DER, instructing the DER to contact the employee.
(i) You must simply direct the DER to inform the employee to contact you.
(ii) You must not inform the DER that the employee has a confirmed positive, adulterated, substituted, or invalid test result.
(iii) You must document the dates and times of your attempts to contact the DER, and you must document the name of the DER you contacted and the date and time of the contact.
(d) As the DER, you must attempt to contact the employee immediately, using procedures that protect, as much as possible, the confidentiality of the MRO’s request that the employee contact the MRO. If you successfully contact the employee (i.e., actually talk to the employee), you must document the date and time of the contact, and inform the MRO. You must inform the employee that he or she should contact the MRO immediately. You must also inform the employee of the consequences of failing to contact the MRO within the next 72 hours (see § 40.133(a)(2)).
(1) As the DER, you must not inform anyone else working for the employer that you are seeking to contact the employee on behalf of the MRO.
(2) If, as the DER, you have made all reasonable efforts to contact the employee but failed to do so, you may place the employee on temporary medically unqualified status or medical leave. Reasonable efforts include, as a minimum, three attempts, spaced reasonably over a 24-hour period, to reach the employee at the day and evening telephone numbers listed on the CCF.
(i) As the DER, you must document the dates and times of these efforts.
(ii) If, as the DER, you are unable to contact the employee within this 24-hour period, you must leave a message for the employee by any practicable means (e.g., voice mail, e-mail, letter) to contact the MRO and inform the MRO of the date and time of this attempted contact.

§40.133 Under what circumstances may the MRO verify a test as positive, or as a refusal to test because of adulteration or substitution, without interviewing the employee?
(a) As the MRO, you normally may verify a confirmed positive test (for any drug or drug metabolite, including opiates), or as a refusal to test because of adulteration or substitution, only after interviewing the employee as provided in §§40.135 – 40.145 . However, there are three circumstances in which you may verify such a result without an interview:
(1) You may verify a test result as a positive or refusal to test, as applicable, if the employee expressly declines the opportunity to discuss the test with you. You must maintain complete documentation of this occurrence, including notation of informing, or attempting to inform, the employee of the consequences of not exercising the option to speak with the you.
(2) You may verify a test result as a positive or refusal to test, as applicable, if the DER has successfully made and documented a contact with the employee and instructed the employee to contact you and more than 72 hours have passed since the time the DER contacted the employee.
(3) You may verify a test result as a positive or refusal to test, as applicable, if neither you nor the DER, after making and documenting all reasonable efforts, has been able to contact the employee within ten days of the date on which the MRO receives the confirmed test result from the laboratory.
(b) As the MRO, when you verify a test result as a positive or refusal to test under this section, you must document the date, time and reason, following the instructions in §40.163 .
(c) As the MRO, after you have verified a test result as a positive or refusal to test under this section and reported the result to the DER, you must allow the employee to present information to you within 60 days of the verification documenting that serious illness, injury, or other circumstances unavoidably precluded contact with the MRO and/or DER in the times provided. On the basis of such information, you may reopen the verification, allowing the employee to present information concerning whether there is a legitimate medical explanation for the confirmed test result.

§40.135 What does the MRO tell the employee at the beginning of the verification interview?
(a) As the MRO, you must tell the employee that the laboratory has determined that the employee’s test result was positive, adulterated, substituted, or invalid, as applicable. You must also tell the employee of the drugs for which his or her specimen tested positive, or the basis for the finding of adulteration or substitution.
(b) You must explain the verification interview process to the employee and inform the employee that your decision will be based on information the employee provides in the interview.
(c) You must explain that, if further medical evaluation is needed for the verification process, the employee must comply with your request for this evaluation and that failure to do so is equivalent of expressly declining to discuss the test result.
(d) As the MRO, you must warn an employee who has a confirmed positive, adulterated, substituted or invalid test that you are required to provide to third parties drug test result information and medical information affecting the performance of safety-sensitive duties that the employee gives you in the verification process without the employee’s consent (see §40.327).
(1) You must give this warning to the employee before obtaining any medical information as part of the verification process.
(2) For purposes of this paragraph (d), medical information includes information on medications or other substances affecting the performance of safety-sensitive duties that the employee reports using or medical conditions the employee reports having.
(3) For purposes of this paragraph (d), the persons to whom this information may be provided include the employer, a SAP evaluating the employee as part of the return to duty process (see §40.293(g)), DOT, another Federal safety agency (e.g., the NTSB), or any state safety agency as required by state law.
(e)You must also advise the employee that, after informing any third party about any medication the employee is using pursuant to a legally valid prescription under the Controlled Substances Act, you will allow 5 days for the employee to have the prescribing physician contact you to determine if the medication can be changed to one that does not make the employee medically unqualified or does not pose a significant safety risk. If, as an MRO, you receive such information from the prescribing physician, you must transmit this information to any third party to whom you previously provided information about the safety risks of the employee’s other medication.

§40.137 On what basis does the MRO verify test results involving marijuana, cocaine, amphetamines, or PCP?
(a) As the MRO, you must verify a confirmed positive test result for marijuana, cocaine, amphetamines, and/or PCP unless the employee presents a legitimate medical explanation for the presence of the drug(s)/ metabolite(s) in his or her system.
(b) You must offer the employee an opportunity to present a legitimate medical explanation in all cases.
(c) The employee has the burden of proof that a legitimate medical explanation exists. The employee must present information meeting this burden at the time of the verification interview. As the MRO, you have discretion to extend the time available to the employee for this purpose for up to five days before verifying the test result, if you determine that there is a reasonable basis to believe that the employee will be able to produce relevant evidence concerning a legitimate medical explanation within that time.
(d) If you determine that there is a legitimate medical explanation, you must verify the test result as negative. Otherwise, you must verify the test result as positive.
(e) In determining whether a legitimate medical explanation exists, you may consider the employee’s use of a medication from a foreign country. You must exercise your professional judgment consistently with the following principles:
(1) There can be a legitimate medical explanation only with respect to a substance that is obtained legally in a foreign country.
(2) There can be a legitimate medical explanation only with respect to a substance that has a legitimate medical use. Use of a drug of abuse (e.g., heroin, PCP, marijuana) or any other substance (see §40.151(f) and (g)) that cannot be viewed as having a legitimate medical use can never be the basis for a legitimate medical explanation, even if the substance is obtained legally in a foreign country.
(3) Use of the substance can form the basis of a legitimate medical explanation only if it is used consistently with its proper and intended medical purpose.
(4) Even if you find that there is a legitimate medical explanation under this paragraph (e) and verify a test negative, you may have a responsibility to raise fitness-for-duty considerations with the employer (see §40.327 ).

§40.139 On what basis does the MRO verify test results involving opiates?
As the MRO, you must proceed as follows when you receive a laboratory confirmed positive opiate result:
(a) If the laboratory detects the presence of 6-acetylmorphine (6-AM) in the specimen, you must verify the test result positive.
(b) In the absence of 6-AM, if the laboratory detects the presence of either morphine or codeine at 15,000 ng/mL or above, you must verify the test result positive unless the employee presents a legitimate medical explanation for the presence of the drug or drug metabolite in his or her system, as in the case of other drugs (see §40.137 ). Consumption of food products (e.g., poppy seeds) must not be considered a legitimate medical explanation for the employee having morphine or codeine at these concentrations.
(c) For all other opiate positive results, you must verify a confirmed positive test result for opiates only if you determine that there is clinical evidence, in addition to the urine test, of unauthorized use of any opium, opiate, or opium derivative (i.e., morphine, heroin, or codeine).
(1) As an MRO, it is your responsibility to use your best professional and ethical judgement and discretion to determine whether there is clinical evidence of unauthorized use of opiates. Examples of information that you may consider in making this judgement include, but are not limited to, the following:
(i) Recent needle tracks;
(ii) Behavioral and psychological signs of acute opiate intoxication or withdrawal;
(iii) Clinical history of unauthorized use recent enough to have produced the laboratory test result;
(iv) Use of a medication from a foreign country. See §40.137(e) for guidance on how to make this determination.
(2) In order to establish the clinical evidence referenced in paragraphs (c)(1)(i) and (ii) of this section, personal observation of the employee is essential.
(i) Therefore, you, as the MRO, must conduct, or cause another physician to conduct, a face-to-face examination of the employee.
(ii) No face-to-face examination is needed in establishing the clinical evidence referenced in paragraph (c)(1)(iii) or (iv) of this section.
(3) To be the basis of a verified positive result for opiates, the clinical evidence you find must concern a drug that the laboratory found in the specimen. (For example, if the test confirmed the presence of codeine, and the employee admits to unauthorized use of hydrocodone, you do not have grounds for verifying the test positive. The admission must be for the substance that was found).
(4) As the MRO, you have the burden of establishing that there is clinical evidence of unauthorized use of opiates referenced in this paragraph (c). If you cannot make this determination (e.g., there is not sufficient clinical evidence or history), you must verify the test as negative. The employee does not need to show you that a legitimate medical explanation exists if no clinical evidence is established.

§40.141 How does the MRO obtain information for the verification decision?
As the MRO, you must do the following as you make the determinations needed for a verification decision:
(a) You must conduct a medical interview. You must review the employee’s medical history and any other relevant biomedical factors presented to you by the employee. You may direct the employee to undergo further medical evaluation by you or another physician.
(b) If the employee asserts that the presence of a drug or drug metabolite in his or her specimen results from taking prescription medication, you must review and take all reasonable and necessary steps to verify the authenticity of all medical records the employee provides. You may contact the employee’s physician or other relevant medical personnel for further information.

§40.143 [Reserved]

§40.145 On what basis does the MRO verify test results involving adulteration or substitution?
(a) As an MRO, when you receive a laboratory report that a specimen is adulterated or substituted, you must treat that report in the same way you treat the laboratory’s report of a confirmed positive test for a drug or drug metabolite.
(b) You must follow the same procedures used for verification of a confirmed positive test for a drug or drug metabolite (see §§40.129 – 40.135, 40.141, 40.151 ), except as otherwise provided in this section.
(c) In the verification interview, you must explain the laboratory findings to the employee and address technical questions or issues the employee may raise.
(d) You must offer the employee the opportunity to present a legitimate medical explanation for the laboratory findings with respect to presence of the adulterant in, or the creatinine and specific gravity findings for, the specimen.
(e) The employee has the burden of proof that there is a legitimate medical explanation.
(1) To meet this burden in the case of an adulterated specimen, the employee must demonstrate that the adulterant found by the laboratory entered the specimen through physiological means.
(2) To meet this burden in the case of a substituted specimen, the employee must demonstrate that he or she did produce or could have produced urine, through physiological means, meeting the creatinine and specific gravity criteria of §40.93(b).
(3) The employee must present information meeting this burden at the time of the verification interview. As the MRO, you have discretion to extend the time available to the employee for this purpose for up to five days before verifying the specimen, if you determine that there is a reasonable basis to believe that the employee will be able to produce relevant evidence supporting a legitimate medical explanation within that time.
(f) As the MRO or the employer, you are not responsible for arranging, conducting, or paying for any studies, examinations or analyses to determine whether a legitimate medical explanation exists.
(g) As the MRO, you must exercise your best professional judgment in deciding whether the employee has established a legitimate medical explanation.
(1) If you determine that the employee’s explanation does not present a reasonable basis for concluding that there may be a legitimate medical explanation, you must report the test to the DER as a verified refusal to test because of adulteration or substitution, as applicable.
(2) If you believe that the employee’s explanation may present a reasonable basis for concluding that there is a legitimate medical explanation, you must direct the employee to obtain, within the five-day period set forth in paragraph (e)(3) of this section, a further medical evaluation. This evaluation must be performed by a licensed physician (the “referral physician”), acceptable to you, with expertise in the medical issues raised by the employee’s explanation. (The MRO may perform this evaluation if the MRO has appropriate expertise.)
(i) As the MRO or employer, you are not responsible for finding or paying a referral physician. However, on request of the employee, you must provide reasonable assistance to the employee’s efforts to find such a physician. The final choice of the referral physician is the employee’s, as long as the physician is acceptable to you.
(ii) As the MRO, you must consult with the referral physician, providing guidance to him or her concerning his or her responsibilities under this section. As part of this consultation, you must provide the following information to the referral physician:
(A) That the employee was required to take a DOT drug test, but the laboratory reported that the specimen was adulterated or substituted, which is treated as a refusal to test;
(B) The consequences of the appropriate DOT agency regulation for refusing to take the required drug test;
(C) That the referral physician must agree to follow the requirements of paragraphs (g) (3) through (g) (4) of this section; and
(D) That the referral physician must provide you with a signed statement of his or her recommendations.
(3) As the referral physician, you must evaluate the employee and consider any evidence the employee presents concerning the employee’s medical explanation. You may conduct additional tests to determine whether there is a legitimate medical explanation. Any additional urine tests must be performed in an HHS-certified laboratory.
(4) As the referral physician, you must then make a written recommendation to the MRO about whether the MRO should determine that there is a legitimate medical explanation. As the MRO, you must seriously consider and assess the referral physician’s recommendation in deciding whether there is a legitimate medical explanation.
(5) As the MRO, if you determine that there is a legitimate medical explanation, you must cancel the test and inform ODAPC in writing of the determination and the basis for it (e.g., referral physician’s findings, evidence produced by the employee).
(6) As the MRO, if you determine that there is not a legitimate medical explanation, you must report the test to the DER as a verified refusal to test because of adulteration or substitution.
(h) The following are examples of types of evidence an employee could present to support an assertion of a legitimate medical explanation for a substituted result.
(1) Medically valid evidence demonstrating that the employee is capable of physiologically producing urine meeting the creatinine and specific gravity criteria of §40.93(b) .
(i) To be regarded as medically valid, the evidence must have been gathered using appropriate methodology and controls to ensure its accuracy and reliability.
(ii) Assertion by the employee that his or her personal characteristics (e.g., with respect to race, gender, weight, diet, working conditions) are responsible for the substituted result does not, in itself, constitute a legitimate medical explanation. To make a case that there is a legitimate medical explanation, the employee must present evidence showing that the cited personal characteristics actually result in the physiological production of urine meeting the creatinine and specific gravity criteria of §40.93(b) .
(2) Information from a medical evaluation under paragraph (g) of this section that the individual has a medical condition that has been demonstrated to cause the employee to physiologically produce urine meeting the creatinine and specific gravity criteria of §40.93(b) .
(i) A finding or diagnosis by the physician that an employee has a medical condition, in itself, does not constitute a legitimate medical explanation.
(ii) To establish there is a legitimate medical explanation, the employee must demonstrate that the cited medical condition actually results in the physiological production of urine meeting the creatinine and specific gravity criteria of §40.93(b) .

§40.147 [Reserved]

§40.149 May the MRO change a verified positive drug test result or refusal to test?
(a) As the MRO, you may change a verified positive or refusal to test drug test result only in the following situations:
(1) When you have reopened a verification that was done without an interview with an employee (see §40.133(c)).
(2) If you receive information, not available to you at the time of the original verification, demonstrating that the laboratory made an error in identifying (e.g., a paperwork mistake) or testing (e.g., a false positive or negative) the employee’s primary or split specimen. For example, suppose the laboratory originally reported a positive test result for Employee X and a negative result for Employee Y. You verified the test results as reported to you. Then the laboratory notifies you that it mixed up the two test results, and X was really negative and Y was really positive. You would change X’s test result from positive to negative and contact Y to conduct a verification interview.
(3) If, within 60 days of the original verification decision —
(i) You receive information that could not reasonably have been provided to you at the time of the decision demonstrating that there is a legitimate medical explanation for the presence of drug(s)/metabolite(s) in the employee’s specimen; or
(ii) You receive credible new or additional evidence that a legitimate medical explanation for an adulterated or substituted result exists.
Example to Paragraph (a)(3): If the employee’s physician provides you a valid prescription that he or she failed to find at the time of the original verification, you may change the test result from positive to negative if you conclude that the prescription provides a legitimate medical explanation for the drug(s)/ metabolite(s) in the employee’s specimen.
(4) If you receive the information in paragraph (a)(3) of this section after the 60-day period, you must consult with ODAPC prior to changing the result.
(5) When you have made an administrative error and reported an incorrect result.
(b) If you change the result, you must immediately notify the DER in writing, as provided in §§40.163 – 40.165.
(c) You are the only person permitted to change a verified test result, such as a verified positive test result or a determination that an individual has refused to test because of adulteration or substitution. This is because, as the MRO, you have the sole authority under this part to make medical determinations leading to a verified test (e.g., a determination that there was or was not a legitimate medical explanation for a laboratory test result). For example, an arbitrator is not permitted to overturn the medical judgment of the MRO that the employee failed to present a legitimate medical explanation for a positive, adulterated, or substituted test result of his or her specimen.

§40.151 What are MROs prohibited from doing as part of the verification process?
As an MRO, you are prohibited from doing the following as part of the verification process:
(a) You must not consider any evidence from tests of urine samples or other body fluids or tissues (e.g., blood or hair samples) that are not collected or tested in accordance with this part. For example, if an employee tells you he went to his own physician, provided a urine specimen, sent it to a laboratory, and received a negative test result or a DNA test result questioning the identity of his DOT specimen, you are required to ignore this test result.
(b) It is not your function to make decisions about factual disputes between the employee and the collector concerning matters occurring at the collection site that are not reflected on the CCF (e.g., concerning allegations that the collector left the area or left open urine containers where other people could access them).
(c) It is not your function to determine whether the employer should have directed that a test occur. For example, if an employee tells you that the employer misidentified her as the subject of a random test, or directed her to take a reasonable suspicion or post-accident test without proper grounds under a DOT agency drug or alcohol regulation, you must inform the employee that you cannot play a role in deciding these issues.
(d) It is not your function to consider explanations of confirmed positive, adulterated, or substituted test results that would not, even if true, constitute a legitimate medical explanation. For example, an employee may tell you that someone slipped amphetamines into her drink at a party, that she unknowingly ingested a marijuana brownie, or that she traveled in a closed car with several people smoking crack. MROs are unlikely to be able to verify the facts of such passive or unknowing ingestion stories. Even if true, such stories do not present a legitimate medical explanation. Consequently, you must not declare a test as negative based on an explanation of this kind.
(e) You must not verify a test negative based on information that a physician recommended that the employee use a drug listed in Schedule I of the Controlled Substances Act. (e.g., under a state law that purports to authorize such recommendations, such as the “medical marijuana” laws that some states have adopted).
(f) You must not accept an assertion of consumption or other use of a hemp or other non-prescription marijuana-related product as a basis for verifying a marijuana test negative. You also must not accept such an explanation related to consumption of coca teas as a basis for verifying a cocaine test result as negative. Consuming or using such a product is not a legitimate medical explanation.
(g) You must not accept an assertion that there is a legitimate medical explanation for the presence of PCP or 6-AM in a specimen. There are no legitimate medical explanations for the presence of these substances.
(h) You must not accept, as a legitimate medical explanation for an adulterated specimen, an assertion that soap, bleach, or glutaraldehyde entered a specimen through physiological means. There are no physiological means through which these substances can enter a specimen.
(i) You must not accept, as a legitimate medical explanation for a substituted specimen, an assertion that an employee can produce urine with no detectable creatinine. There are no physiological means through which a person can produce a urine specimen having this characteristic.

§40.153 How does the MRO notify employees of their right to a test of the split specimen?
(a) As the MRO, when you have verified a drug test as positive for a drug or drug metabolite, or as a refusal to test because of adulteration or substitution, you must notify the employee of his or her right to have the split specimen tested. You must also notify the employee of the procedures for requesting a test of the split specimen.
(b) You must inform the employee that he or she has 72 hours from the time you provide this notification to him or her to request a test of the split specimen.
(c) You must tell the employee how to contact you to make this request. You must provide telephone numbers or other information that will allow the employee to make this request. As the MRO, you must have the ability to receive the employee’s calls at all times during the 72 hour period (e.g., by use of an answering machine with a “time stamp” feature when there is no one in your office to answer the phone).
(d) You must tell the employee that if he or she makes this request within 72 hours, the employer must ensure that the test takes place, and that the employee is not required to pay for the test from his or her own funds before the test takes place. You must also tell the employee that the employer may seek reimbursement for the cost of the test (see §40.173 ).
(e) You must tell the employee that additional tests of the specimen (e.g., DNA tests) are not authorized.

§40.155 What does the MRO do when a negative or positive test result is also dilute?
(a) When the laboratory reports that a specimen is dilute, you must, as the MRO, report to the DER that the specimen, in addition to being negative or positive, is dilute.
(b) You must check the “dilute” box (Step 6) on Copy 2 of the CCF.
(c) When you report a dilute specimen to the DER, you must explain to the DER the employer’s obligations and choices under §40.197.

§40.157 [Reserved]

§40.159 What does the MRO do when a drug test result is invalid?
(a) As the MRO, when the laboratory reports that the test result is an invalid result, you must do the following:
(1) Discuss the laboratory results with a certifying scientist to obtain more specific information.
(2) Contact the employee and inform the employee that the specimen was invalid or contained an unexplained interfering substance. In contacting the employee, use the procedures set forth in §40.131 .
(3) After explaining the limits of disclosure (see §§ 40.135(d) and 40.327), you should inquire as to medications the employee may have taken that may interfere with some immunoassay tests.
(4) If the employee gives an explanation that is acceptable, you must:
(i) Place a check mark in the “Test Cancelled” box (Step 6) on Copy 2 of the CCF and enter “Invalid Result” and “direct observation collection not required” on the “Remarks” line.
(ii) Report to the DER that the test is cancelled, the reason for cancellation, and that no further action is required unless a negative test result is required (i.e., pre-employment, return-to-duty, or follow-up tests).
(5) If the employee is unable to provide an explanation and/or a valid prescription for a medication that interfered with the immunoassay test but denies having adulterated the specimen, you must:
(i) Place a check mark in the “Test Cancelled” box (Step 6) on Copy 2 of the CCF and enter “Invalid Result” and “direct observation collection required” on the “Remarks” line.
(ii) Report to the DER that the test is cancelled, the reason for cancellation, and that a second collection must take place immediately under direct observation.
(iii) Instruct the employer to ensure that the employee has the minimum possible advance notice that he or she must go to the collection site.
(b) You may only report an invalid test result when you are in possession of a legible copy of Copy 1 of the CCF. In addition, you must have Copy 2 of the CCF, a legible copy of it, or any other copy of the CCF containing the employee’s signature.
(c) If the employee admits to having adulterated or substituted the specimen, you must, on the same day, write and sign your own statement of what the employee told you. You must then report a refusal to test in accordance with §40.163 .

§40.161 What does the MRO do when a drug test specimen is rejected for testing?
As the MRO, when the laboratory reports that the specimen is rejected for testing (e.g., because of a fatal or uncorrected flaw), you must do the following:
(a) Place a check mark in the “Test Cancelled” box (Step 6) on Copy 2 of the CCF and enter the reason on the “Remarks” line.
(b) Report to the DER that the test is cancelled and the reason for cancellation, and that no further action is required unless a negative test is required (e.g., in the case of a pre-employment, return-to-duty, or follow-up test).
(c) You may only report a test cancelled because of a rejected for testing test result when you are in possession of a legible copy of Copy 1 of the CCF. In addition, you must have Copy 2 of the CCF, a legible copy of it, or any other copy of the CCF containing the employee’s signature.

§40.163 How does the MRO report drug test results?
(a) As the MRO, it is your responsibility to report all drug test results to the employer.
(b) You may use a signed or stamped and dated legible photocopy of Copy 2 of the CCF to report test results.
(c) If you do not report test results using Copy 2 of the CCF for this purpose, you must provide a written report (e.g., a letter) for each test result. This report must, as a minimum, include the following information:
(1) Full name, as indicated on the CCF, of the employee tested;
(2) Specimen ID number from the CCF and the donor SSN or employee ID number;
(3) Reason for the test, if indicated on the CCF (e.g., random, post-accident);
(4) Date of the collection;
(5) Date you received Copy 2 of the CCF;
(6) Result of the test (i.e., positive, negative, dilute, refusal to test, test cancelled) and the date the result was verified by the MRO;
(7) For verified positive tests, the drug(s)/metabolite(s) for which the test was positive;
(8) For cancelled tests, the reason for cancellation; and
(9) For refusals to test, the reason for the refusal determination (e.g., in the case of an adulterated test result, the name of the adulterant).
(d) As an exception to the reporting requirements of paragraph (b) and (c) of this section, the MRO may report negative results using an electronic data file.
(1) If you report negatives using an electronic data file, the report must contain, as a minimum, the information specified in paragraph (c) of this section, as applicable for negative test results.
(2) In addition, the report must contain your name, address, and phone number, the name of any person other than you reporting the results, and the date the electronic results report is released.
(e) You must retain a signed or stamped and dated copy of Copy 2 of the CCF in your records. If you do not use Copy 2 for reporting results, you must maintain a copy of the signed or stamped and dated letter in addition to the
signed or stamped and dated Copy 2. If you use the electronic data file to report negatives, you must maintain a retrievable copy of that report in a format suitable for inspection and auditing by a DOT representative.
(f) You must not use Copy 1 of the CCF to report drug test results.
(g) You must not provide quantitative values to the DER or C/TPA for drug or validity test results. However, you must provide the test information in your possession to a SAP who consults with you (see § 40.293(g)).

§40.165 To whom does the MRO transmit reports of drug test results?
(a) As the MRO, you must report all drug test results to the DER, except in the circumstances provided for in §40.345 .
(b) If the employer elects to receive reports of results through a C/TPA, acting as an intermediary as provided in §40.345 , you must report the results through the designated C/TPA.

§40.167 How are MRO reports of drug results transmitted to the employer?
As the MRO or C/TPA who transmits drug test results to the employer, you must comply with the following requirements:
(a) You must report the results in a confidential manner.
(b) You must transmit to the DER on the same day the MRO verifies the result or the next business day all verified positive test results, results requiring an immediate collection under direct observation, adulterated or substituted specimen results, and other refusals to test.
(1) Direct telephone contact with the DER is the preferred method of immediate reporting. Follow up your phone call with appropriate documentation (see §40.163).
(2) You are responsible for identifying yourself to the DER, and the DER must have a means to confirm your identification.
(3) The MRO’s report that you transmit to the employer must contain all of the information required by §40.163 .
(c) You must transmit the MRO’s report(s) of verified tests to the DER so that the DER receives it within two days of verification by the MRO.
(1) You must fax, courier, mail, or electronically transmit a legible image or copy of either the signed or stamped and dated Copy 2 or the written report (see §40.163(b) and (c)).
(2) Negative results reported electronically (i.e., computer data file) do not require an image of Copy 2 or the written report.
(d) In transmitting test results, you or the C/TPA and the employer must ensure the security of the transmission and limit access to any transmission, storage, or retrieval systems.
(e) MRO reports are not subject to modification or change by anyone other than the MRO, as provided in §40.149(c).

§40.169 Where is other information concerning the role of MROs and the verification process found in this regulation?
You can find more information concerning the role of MROs in several sections of this part:
§40.3 – definition.
§§40.47 – 40.49 – correction of form and kit errors.
§40.67 – role in direct observation and other atypical test situations.
§40.83 – laboratory handling of fatal and correctable flaws.
§40.97 – laboratory handling of test results and quantitative values.
§40.99 – authorization of longer laboratory retention of specimens.
§40.101 – relationship with laboratories; avoidance of conflicts of interest.
§40.105 – notification of discrepancies in blind specimen results.
§40.171 – request for test of split specimen.
§40.187 – action concerning split specimen test results.
§40.193 – role in “shy bladder” situations.
§40.195 – role in cancelling tests.
§§40.199 – 40.203 – documenting errors in tests.
§40.327 – confidentiality and release of information.
§40.347 – transfer of records.
§40.353 – relationships with service agents.

Subpart H – Split Specimen Tests
§40.171 How does an employee request a test of a split specimen?
(a) As an employee, when the MRO has notified you that you have a verified positive drug test or refusal to test because of adulteration or substitution, you have 72 hours from the time of notification to request a test of the split specimen. The request may be verbal or in writing. If you make this request to the MRO within 72 hours, you trigger the requirements of this section for a test of the split specimen.
(b)(1) If, as an employee, you have not requested a test of the split specimen within 72 hours, you may present to the MRO information documenting that serious injury, illness, lack of actual notice of the verified test result, inability to contact the MRO (e.g., there was no one in the MRO’s office and the answering machine was not working), or other circumstances unavoidably prevented you from making a timely request.
(2) As the MRO, if you conclude from the employee’s information that there was a legitimate reason for the employee’s failure to contact you within 72 hours, you must direct that the test of the split specimen take place, just as you would when there is a timely request.
(c) When the employee makes a timely request for a test of the split specimen under paragraphs (a) and (b) of this section, you must, as the MRO, immediately provide written notice to the laboratory that tested the primary specimen, directing the laboratory to forward the split specimen to a second HHS-certified laboratory. You must also document the date and time of the employee’s request.

§40.173 Who is responsible for paying for the test of a split specimen?
(a) As the employer, you are responsible for making sure (e.g., by establishing appropriate accounts with laboratories for testing split specimens) that the MRO, first laboratory, and second laboratory perform the functions noted in §§40.175 – 40.185 in a timely manner, once the employee has made a timely request for a test of the split specimen.
(b) As the employer, you must not condition your compliance with these requirements on the employee’s direct payment to the MRO or laboratory or the employee’s agreement to reimburse you for the costs of testing. For example, if you ask the employee to pay for some or all of the cost of testing the split specimen, and the employee is unwilling or unable to do so, you must ensure that the test takes place in a timely manner, even though this means that you pay for it.
(c) As the employer, you may seek payment or reimbursement of all or part of the cost of the split specimen from the employee (e.g., through your written company policy or a collective bargaining agreement). This part takes no position on who ultimately pays the cost of the test, so long as the employer ensures that the testing is conducted as required and the results released appropriately.

§40.175 What steps does the first laboratory take with a split specimen?
(a) As the laboratory at which the primary and split specimen first arrive, you must check to see whether the split specimen is available for testing.
(b) If the split specimen is unavailable or appears insufficient, you must then do the following:
(1) Continue the testing process for the primary specimen as you would normally. Report the results for the primary specimen without providing the MRO information regarding the unavailable split specimen.
(2) Upon receiving a letter from the MRO instructing you to forward the split specimen to another laboratory for testing, report to the MRO that the split specimen is unavailable for testing. Provide as much information as you can about the cause of the unavailability.
(c) As the laboratory that tested the primary specimen, you are not authorized to open the split specimen under any circumstances (except when the split specimen is redesignated as provided in §40.83 ).
(d) When you receive written notice from the instructing you to send the split specimen to another HHS-certified laboratory, you must forward the following items to the second laboratory:
(1) The split specimen in its original specimen bottle, with the seal intact;
(2) A copy of the MRO’s written request; and
(3) A copy of Copy 1 of the CCF, which identifies the drug(s)/metabolite(s) or the validity criteria to be tested for.
(e) You must not send to the second laboratory any information about the identity of the employee. Inadvertent disclosure does not, however, cause a fatal flaw.
(f) This subpart does not prescribe who gets to decide which HHS-certified laboratory is used to test the split specimen. That decision is left to the parties involved.

§40.177 What does the second laboratory do with the split specimen when it is tested to reconfirm the presence of a drug or drug metabolite?
(a) As the laboratory testing the split specimen, you must test the split specimen for the drug(s)/drug metabolite(s) detected in the primary specimen.
(b) You must conduct this test without regard to the cutoff concentrations of §40.87 .
(c) If the test fails to reconfirm the presence of the drug(s)/drug metabolite(s) that were reported positive in the primary specimen, you must conduct validity tests in an attempt to determine the reason for being unable to reconfirm the presence of the drug(s)/metabolite(s). You should conduct the same validity tests as you would conduct on a primary specimen set forth in §40.91 .
(d) In addition, if the test fails to reconfirm the presence of the drugs/drugs metabolites or validity criteria that were reported in the primary specimen, you may transmit the specimen or an aliquot of it to another HHS-certified laboratory that will conduct another reconfirmation test.

§40.179 What does the second laboratory do with the split specimen when it is tested to reconfirm an adulterated test result?
As the laboratory testing the split specimen, you must test the split specimen for the adulterant detected in the primary specimen, using the criteria of §40.95 just as you would do for a primary specimen. The result of the primary specimen is reconfirmed if the split specimen meets these criteria.

§40.181 What does the second laboratory do with the split specimen when it is tested to reconfirm a substituted test result?
As the laboratory testing the split specimen, you must test the split specimen using the criteria of §40.93(b) , just as you would do for a primary specimen. The result of the primary specimen is reconfirmed if the split specimen meets these criteria.

§40.183 What information do laboratories report to MROs regarding split specimen results?
(a) As the laboratory responsible for testing the split specimen, you must report split specimen test results by checking the “Reconfirmed” box or the “Failed to Reconfirm” box (Step 5(b)) on Copy 1 of the CCF.
(b) If you check the “Failed to Reconfirm” box, one of the following statements must be included (as appropriate) on the “Reason” line (Step 5(b)):
(1) “Drug(s)/Drug Metabolite(s) Not Detected.”
(2) “Adulterant not found within criteria.”
(3) “Specimen not consistent with substitution criteria [specify creatinine, specific gravity, or both]”
(4) “Specimen not available for testing.”
(c) As the laboratory certifying scientist, enter your name, sign, and date the CCF.

§40.185 Through what methods and to whom must a laboratory report split specimen results?
(a) As the laboratory testing the split specimen, you must report laboratory results directly, and only, to the MRO at his or her place of business. You must not report results to or through the DER or another service agent (e.g., a C/TPA).
(b) You must fax, courier, mail, or electronically transmit a legible image or copy of the fully-completed Copy 1 of the CCF, which has been signed by the certifying scientist.
(c) You must transmit the laboratory result to the MRO immediately, preferably on the same day or next business day as the result is signed and released.

§40.187 What does the MRO do with split specimen laboratory results?
As an MRO, you must take the following actions when a laboratory reports the following results of split specimen tests:
(a) Reconfirmed. (1) In the case of a reconfirmed positive test for a drug or drug metabolite, report the reconfirmation to the DER and the employee.
(2) In the case of a reconfirmed adulterated or substituted result, report to the DER and the employee that the specimen was adulterated or substituted, either of which constitutes a refusal to test. Therefore, “refusal to test” is the final result.
(b) Failed to Reconfirm: Drug(s)/Drug Metabolite(s) Not Detected. (1) Report to the DER and the employee that both tests must be cancelled.
(2) Using the format in Appendix D to this part, inform ODAPC of the failure to reconfirm.
(c) Failed to Reconfirm: Adulteration or Substitution (as appropriate) Criteria Not Met. (1) Report to the DER and the employee that both tests must be cancelled.
(2) Using the format in Appendix D to this part, inform ODAPC of the failure to reconfirm.
(d) Failed to Reconfirm: Specimen not Available for Testing. (1) Report to the DER and the employee that both tests must be cancelled and the reason for cancellation.
(2) Direct the DER to ensure the immediate collection of another specimen from the employee under direct observation, with no notice given to the employee of this collection requirement until immediately before the collection.
(3) Using the format in Appendix D to this part, notify ODAPC of the failure to reconfirm.
(e) Failed to Reconfirm: Specimen Results Invalid.
(1) Report to the DER and the employee that both tests must be cancelled and the reason for cancellation.
(2) Direct the DER to ensure the immediate collection of another specimen from the employee under direct observation, with no notice given to the employee of this collection requirement until immediately before the collection.
(3) Using the format in Appendix D to this part, notify ODAPC of the failure to reconfirm.
(f) Failed to Reconfirm: Split Specimen Adulterated.
(1) Contact the employee and inform the employee that the laboratory has determined that his or her split specimen is adulterated.
(2) Follow the procedures of §40.145 to determine if there is a legitimate medical explanation for the laboratory finding of adulteration.
(3) If you determine that there is a legitimate medical explanation for the adulterated test result, report to the DER and the employee that the test is cancelled. Using the format in Appendix D to this part, notify ODAPC of the result.
(4) If you determine that there is not a legitimate medical explanation for the adulterated test result, take the following steps:
(i) Report the test to the DER and the employee as a verified refusal to test. Inform the employee that he or she has 72 hours to request a test of the primary specimen to determine if the adulterant found in the split specimen also is present in the primary specimen.
(ii) Except that the request is for a test of the primary specimen and is being made to the laboratory that tested the primary specimen, follow the procedures of §§40.153, 40.171, 40.173, 40.179, and 40.185.
(iii) As the laboratory that tests the primary specimen to reconfirm the presence of the adulterant found in the split specimen, report your result to the MRO on a photocopy (faxed, mailed, scanned, couriered) of Copy 1 of the CCF .
(iv) If the test of the primary specimen reconfirms the adulteration finding of the split specimen, as the MRO you must report the test result as a refusal as provided in §40.187(a)(2).
(v) If the test of the primary specimen fails to reconfirm the adulteration finding of the split specimen, as the MRO you cancel the test. Follow the procedures of paragraph (e) of this section in this situation.
(g) Enter your name, sign and date (Step 7) of Copy 2 of the CCF.
(h) Send a legible copy of Copy 2 of the CCF (or a signed and dated letter, see §40.163 ) to the employer and keep a copy for your records. Transmit the document as provided in §40.167.

§40.189 Where is other information concerning split specimens found in this regulation?
You can find more information concerning split specimens in several sections of this part:
§40.3 – definition.
§40.65 – quantity of split specimen.
§40.67 – directly observed test when split specimen is unavailable.
§§40.71 – 40.73 – collection process for split specimens.
§40.83 – laboratory accessioning of split specimens.
§40.99 – laboratory retention of split specimens
§40.103 – blind split specimens.
§40.153 – MRO notice to employees on tests of split specimen.
§§40.193 and 40.201 – MRO actions on insufficient or unavailable split specimens.
Appendix D to Part 40 – Report format for split specimen failure to reconfirm.

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