2001 Highlights of DOT’S

Revised 49 CFR Part 40

Highlighted Changes:

Validity Testing:

MRO’s are required to review substituted and or adulterated test results. Split specimen testing for these results are required as of January 18, 2001.

Split specimen testing for all specimens are mandatory as of August 1, 2001.


Temporarily removing employees from safety-sensitive duties after a confirmed positive, adulterated, or substituted laboratory test result BEFORE the MRO review of that test is prohibited.

Employees can request a waiver permitting a Stand-Down. The waiver must include a written stand-down policy detailing paying workers during the stand-down time, and expunging records of the confirmed test results if the test is confirmed as negative or cancelled.

The waiver request must be directed to the operating administrators before initiating a stand-down policy.

New Definitions and Job Descriptions

DER = Designated Employer Representative. This replaces the old term "Contact Person."

The DER must have the authority to remove an employee from a safety sensitive duty.

The full definition of a DER is: An employee authorized by the employer to take immediate action(s) to remove employees from safety-sensitive duties and to make required decisions in the testing and evaluation processes. The DER also receives test results and other communications for the employer, consistent with the requirements of this part.

SA = Service Agent: Any person or entity, other than the employee of an 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, BAT’s, STT’s, Laboratories, MRO’s, SAP's, and C/TPA's.

Appendix F lists the job responsibilities of the Service Agent for CFR part 40.345 – 40.355

Service Agents CANNOT act as DER’s

Public Interest Exclusions (PIE):

This is an attempt to protect the public from the effects of serious non-compliance by service agents.

A service agent who engages in a serious misconduct could be excluded from participating in DOT-required drug and alcohol testing for a period of time.

A Federal Register is available for employers to consult in determining which service agents have been excluded. (Consult the DOT official web-site for list as well)

There are provisions and proceedings which allow a service agent due process to ensure fairness. This regulation went into effect January 18th 2001.


Part 40 now requires enhanced training for Service Agents, collectors, Breath Alcohol Technicians (BAT’s), Screening Test Technicians (STT’s), Medical Review Officers (MRO’s), and Substance Abuse Professionals (SAP’s).

This includes initial "Qualification Training", refresher training every five years (for Collectors, BAT’s, and STT’s, continuing education for MRO’s and SAP’s, and "Error Correction Training" for collector’s.

The new law mandates that collectors receive formal training in the collection process. However, collectors who have performed DOT collections prior to August 1, 2001 have until August 1, 2003 to undergo this formal training. New collectors (those who begin after August 1, 2001) will have to receive this training before doing any DOT collections.

Collection Process

All DOT agencies are now required to have split specimen collections.

Failure of employee or owner/operator to show up is a "REFUSAL-TO-TEST"

If an alcohol test is required, DO THE ALCOHOL TEST FIRST.

Collectors must explain the collection process to donors. (back of CCF is considered adequate)

The "Shy Bladder" will no longer be considered a refusal to test.

Collectors will not require donors to remove boots, but will require employees to display the contents of their pockets. Any item that the collector perceives as a potential adulterant must be secured until specimen is sealed.

Collectors no longer need to take donors temperature when the specimen temperature exceeds the maximum range of the temperature strip on the collection cup.

Directly Observed collections.

Required by employer directive if:

If the MRO has reported "invalid" result on prior test.

If a split specimen test had to be canceled. (No bottle B).

In these cases, Employer must explain (to donor) the reason for direct observation.

Required by collector directive if:

If a specimen temperature is out of range or appears abnormal to the collector.

If the donors behavior, or sounds suggests an attempt to tamper or substitute.

In these cases, Collectors must explain (to donor) the reason for direct observation.

Custody and Control Forms

A new 5 part form is REQUIRED after August 1, 2001.

Extraneous information, such as billing, is limited to outer borders only.

MRO information (block 1-B) must have specific MRO name & address.

Distribution of Copies for New 5-part CCF

Copy 1: (all white): To laboratory with specimen.

Copy 2: (white with pink edge): To MRO.

Copy 3: (white with yellow edge): Collector keeps.

Copy 4: (white with blue edge): To employer

Copy 5: (white with green edge): To donor

Laboratory Processes

All labs are required to initiate validity testing on all specimens as of August 1, 2001.

NEGATIVE results are permitted to be sent electronically to MRO, thus eliminating the need of paper document transfers.

Laboratories are no longer permitted to recommend MRO’s to customers. Even a "slate" of recommended MRO’s is now forbidden. Labs must now refer queries for an MRO to the "National" Locator pages & list.

The following list is the new possible test results: Negative, Negative-Dilute, Rejected, Positive-Dilute, Adulterated, Substituted, and Invalid.

Positive AND Dilute is a new requirement.

Rejected is a new term, used instead of "Canceled" for a fatal or uncorrected flaw.

Invalid is a new term, formerly was "Unsuitable."

Medical Review Officer - MRO’s

MRO’s are required to personally conduct a verification interview with the employee not only for positive drug results, but also when the specimen is reported as adulterated or substituted.

For opiate verification, if either morphine or codeine is reported at or above 15,000 ng/ml the burden for explanation is shifted to the employee. In specific cases the MRO may require a recollection under direct observation.

The MRO is required to release certain medical information to third parties (employers) if that information indicates a safety issue related to the employee’s continued performance of safety-sensitive functions.

Continuing education is required for MRO’s. 12 CME hours are now required every three years. Note: that the regulations do not mention re-certification.

If the MRO determines that a safety hazard exists with current medication in regards to a safety-sensitive position, he/she must take the following three steps. 1) Get donor consent, and contact prescribing physician. 2) Determine if an alternative medication can be used to avoid disqualification from DOT regulated positions. 3) MUST release donor information WITHOUT donor consent to the following:

The employer under whose policy or rules the test was ordered (Report this unprompted)

A SAP evaluating the donor as part of the RTD process (If requested)

DOT or other federal or state agency as required by law (If requested)

Note: CFR Part 40.135 makes notifying the employer a DUTY!

The MRO has the discretion (at the time of the interview) to grant a donor up to 5 days to gather information. IF, AND ONLY IF the donor convinces the MRO that he/she will be able to carry the burden of proof that legitimately provides a medical explanation for the labs findings.

Substance Abuse Professional (SAP) and The Return to Duty Process

All positive tests and refusals to test have a consequence; SAP’s MUST require education and or treatment in all such cases.

The return to duty process is mandatory following any violation of the rules, including a positive on a pre-employment test.

The current requirement of 6 tests over the first 12 months following an employee’s return to duty or following a suspension is maintained. There is clarification that the follow-up testing requirements follow the employee from one job to another and persist through a break in service.

Return-to-duty process and follow-up testing requirements continue to apply even if workers change jobs or have a break in service.

Role of Consortia/Third Party Administrators (C/TPA)

Results must be transmitted directly and ONLY to MRO at his place of work.

Results reported to (or through) a TPA or DER is specifically forbidden.

Employers may choose to have drug test results and other information transmitted to them via a C/TPA or directly from the MRO or other persons who generates the information. As Service agents, C/TPA’s are not "employers" for the purpose of the rule and cannot play the "Designated Employer Representative" role for employers. C/TPA’s CANNOT RECEIVE TEST RESULTS FROM LABORATORIES!

Alcohol Testing

New Regs. define cornerstones of BAT & STT training

Basic knowledge

Qualification Training

Initial Proficiency Demonstration

Refresher Training every 5 years

Documentation of credentials and CME

Error Correction Training (ECT) required for fatal or uncorrected flaws

A new alcohol testing form has brought about three significant changes: 1) there is an area to place the DER’s name and address. 2) In step three there are now box’s to check for the appropriate title of the one performing the test, and a box for the testing device that is being used. 3) The donor is required to sign step number 4 ONLY if the results is 0.02 or greater.

Other Issues.

Employers will be required to obtain the previous two years drug and alcohol testing information from an applicant’s past employers.

New Chain of Custody

Please note that SMS has changed from Quest to LabOne. New COC forms and supplies for LabOne have been sent to all contracted collection centers. Please remember to call the collection center prior to sending an employee for testing. You MUST send the attached "Important Drug Testing Information Sheet" with the employee. This document serves as the authorization that the Collector must use to determine that the correct test code & COC is used for your specific company. This procedure will insure that the testing process will be done right the first time, preventing additional costs and lost work time. Just a reminder: please submit any roster changes to assure compliance before the Jan.2002 random selections are pulled.