What is a directly observed collection under DOT rules?

A directly observed collection (DOC) is a special urine specimen collection under 49 CFR Part 40 where a same-gender observer watches the donor urinate into the container to prevent tampering, substitution or dilution.

When is an observed collection required instead of a routine collection?

Observed collection is required when there is reason to believe tampering has occurred (e.g., invalid specimen, unacceptable temperature, or previous refusal), or when the test is a return-to-duty or follow-up test under DOT.

Who can serve as the observer during a DOT directly observed collection?

The observer must be the same gender as the donor unless the observer is a medical professional, and must have been trained in the procedures. The observer may not touch the specimen container unless also the collector.

What steps must the observer follow during the collection process?

The observer must watch the donor raise clothing, lower underpants to mid-thigh, turn around to show no prosthetic or device, watch urine go from the body into the container (no video/mirrors) and then maintain visual contact of specimen until handed to the collector.

What happens if the donor refuses to comply with the direct observation procedure?

If the donor refuses any part of the directly observed collection protocol (e.g., refuses to lower clothing, turns away, or leaves the collection site) it is considered a refusal to test, which is treated similarly to a positive test under DOT employer rules.

How should a collector document an observed collection on the Custody & Control Form (CCF)?

The collector must check the box for ‘Observed Collection’, enter in Step 2 the reason for observation, name of the observer (if different), and any relevant remark (e.g., ‘Return-to-Duty’). The collector completes a new CCF for the observed collection.

What training is required for collectors and observers performing DOT observed collections?

Collectors must be trained per Part 40 (§40.33) and observers must be trained on the directly observed procedure, specimen integrity, chain-of-custody, maintaining privacy and professionalism. Training records must be maintained.

What privacy measures must be maintained during an observed collection?

Collections must be conducted in a restroom or equivalent with no unauthorized entry; when the observer enters, it must respect donor dignity, be discreet, and avoid comments or confrontation; and no video or mirrors may be used.

What common errors do collectors/observers make during observed collections?

Common errors include entering the restroom before verifying gender, failing to document properly, not maintaining visual contact with the specimen, not following on-site rules (mirrors/cameras), or forgetting to initiate a new CCF when observation is required.

Why is it important for collectors and observers to strictly follow the observed collection procedures?

Strict compliance ensures the integrity of the testing program, prevents specimen tampering, supports defensible results for regulatory, legal and safety-sensitive functions, and protects both the employer and employee from invalidation or challenges.

DOT Observed Collection: A Guide for Collectors and Observers

If you are a collector or an observer for drug testing under the Department of Transportation (DOT) regulations, you may encounter situations where you have to conduct a directly observed collection. A directly observed collection is a special type of urine specimen collection that requires the collector or an observer to watch the employee provide the specimen.

In this blog post, we will explain what a directly observed collection is, when and how it should be performed, and what are the roles and responsibilities of collectors and observers. We will also provide some tips and best practices to help you conduct a directly observed collection professionally and respectfully.

What is a Directly Observed Collection?

A directly observed collection is a urine specimen collection that requires the collector or an observer to watch the employee provide the specimen. The purpose of a directly observed collection is to prevent cheating or tampering with the specimen, such as by using adulterants, substitutes, or devices, when the specimen is invalid or diluted, or when the test reason is return-to-duty or follow-up.

How Observed Collection is done?

A directly observed collection must also follow specific procedures and protocols to ensure the integrity and validity of the test result. It can only be performed by a collector who has been trained and qualified in accordance with DOT regulations, or by an observer who has been designated by the collector. The observer must be the same gender as the employee, unless the observer is a medical professional.

The observed urine collection must be conducted in a private and secure location that prevents unauthorized access or observation. The collector or the observer must ask the employee to raise his or her clothing above the waist, lower clothing and underpants, and turn around to show that he or she does not have any item that could be used to tamper with the specimen. The collector or the observer must then watch the urine go from the employee’s body into the collection container.

A directly observed collection must be documented on a new Custody and Control Form (CCF) that indicates the reason for the direct observation and the name of the observer. The collector must also follow specific procedures for urine specimen collection, such as checking the temperature, sealing and labeling the specimen, and sending it to the laboratory.

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When is a Directly Observed Collection Required?

A directly observed collection is required only in certain situations that are specified by DOT regulations. These situations are:

The employee attempts to tamper with his or her specimen at the collection site, such as by using adulterants, substitutes, or devices.
The specimen temperature is outside the acceptable range of 90°F to 100°F.
The specimen shows signs of tampering, such as unusual color, odor, or characteristic.
The collector finds an item in the employee’s pockets or wallet that appears to be brought into the site to contaminate a specimen.
The collector notes conduct suggesting tampering, such as excessive delay in providing a specimen or unusual behavior during the collection process.
The laboratory reports to the Medical Review Officer (MRO) that a specimen is invalid, and the MRO determines that there is no adequate medical explanation for the result.
The MRO reports to the employer that the original positive, adulterated, or substituted result had to be cancelled because the test of the split specimen could not be performed.
The laboratory reports to the MRO that the specimen was negative-dilute with a creatinine concentration greater than or equal to 2 mg/dL but less than or equal to 5 mg/dL, and the MRO directs a second collection under direct observation.
The employer realizes that a collection under direct observation was required but was not conducted, or the service agent informs the employer that a direct observation should have been conducted but was not.
The drug test is a return-to-duty test or a follow-up test.

In any of these situations, the employer must direct an immediate collection under direct observation with no advance notice to the employee. The employee must comply with the request for a directly observed collection; otherwise, it will be considered a refusal to test.

What are the Roles and Responsibilities of Collectors and Observers?

Collectors and observers play important roles in ensuring that a directly observed collection is conducted properly and respectfully. Collectors and observers must:

Be trained and qualified in accordance with DOT regulations.
Be familiar with DOT’s direct observation procedures and protocols.
Be respectful of the employee’s privacy and dignity.
Be professional and courteous at all times.
Be impartial and objective in performing their duties.
Be attentive and vigilant in detecting any signs of tampering.
Be accurate and thorough in documenting and reporting any issues or incidents.

Collectors have additional responsibilities, such as:

Informing the employee of the reason for the directly observed collection and explaining the procedures and protocols.
Designating an observer of the same gender as the employee, unless the observer is a medical professional.
Supervising the observer and ensuring that he or she follows the procedures and protocols.
Completing a new CCF for the directly observed collection and indicating the reason and the name of the observer.
Following all other procedures for urine specimen collection, such as checking the temperature, sealing and labeling the specimen, and sending it to the laboratory.

What are Some Tips and Best Practices for Conducting a Directly Observed Collection?

Conducting a directly observed collection can be a challenging and sensitive task, as it involves watching an employee provide a urine specimen. Collectors and observers should follow some tips and best practices to make the process smoother and more comfortable for everyone involved. Some of these tips and best practices are:

Be discreet and respectful: Do not announce or discuss the reason for the directly observed collection in front of other employees or staff. Do not make any comments or gestures that could be perceived as offensive or intrusive. Do not touch or handle the employee or the specimen unless absolutely necessary.
Be clear and concise: Explain to the employee what is expected of him or her and what will happen during the directly observed collection. Use simple and direct language and avoid any jargon or slang. Answer any questions that the employee may have honestly and politely.
Be calm and confident: Maintain a professional demeanor and tone of voice throughout the directly observed collection. Do not show any signs of nervousness, impatience, or frustration. Do not let any personal feelings or biases affect your judgment or performance.
Be fair and consistent: Follow the DOT’s direct observation procedures and protocols exactly as they are written. Do not deviate from or modify them for any reason. Do not make any exceptions or allowances for any employee. Treat every employee equally and impartially.
Be careful and cautious: Watch for any signs of tampering, such as unusual items, behaviors, or specimens. Document and report any issues or incidents promptly and accurately. Do not make any assumptions or accusations without sufficient evidence. Do not engage in any confrontations or arguments with the employee.

Conclusion

A directly observed collection is a special type of urine specimen collection that requires the collector or an observer to watch the employee provide the specimen. It is only required in certain situations where there is a risk of cheating or tampering with the specimen, such as when the test reason is return-to-duty or follow-up.

Collectors and observers must follow specific procedures and protocols to conduct a directly observed collection properly and respectfully. They must also be trained and qualified in accordance with DOT regulations.

Collectors and observers should follow some tips and best practices to make the process smoother and more comfortable for everyone involved, such as being discreet, clear, calm, fair, and careful.

A directly observed collection is an important tool to ensure the integrity and validity of drug testing under DOT regulations. It helps to prevent cheating or tampering with specimens, which could compromise safety and compliance.

Call us at 980-655-4455 for more information about DOT drug & alcohol testing and collection methods. goMDnow is a certified TPA providing services for random drug testing and return-to-duty process for FMCSA and DOT regulated truck drivers. Reach us today for all your drug testing needs.