Drug Testing Challenges Under Part 40 Regulations

Drug Testing Challenges Under Part 40 Regulations

Drug screening has become a standard practice for many employers aiming to maintain a safe and productive workplace. However, the process of collecting samples for drug tests can be fraught with challenges, ranging from logistical issues to concerns about the integrity of the samples. For employers, understanding these common problems and knowing how to address them can significantly improve the effectiveness and reliability of their drug screening programs.

DISA follows for drug screening the DOT-wide 49 CFR Part 40 regulations, a set of comprehensive federal standards widely adopted by employers, even for non-DOT testing, to ensure a structured and legally sound process. Employers may choose to adopt Part 40 guidelines because they provide clear protocols for drug testing, from collector qualifications to specimen handling, ensuring consistency and fairness. This helps protect employers from potential legal claims, promotes best practices in the industry, and fosters a safer, more productive workplace. By aligning with Part 40 standards, employers can maintain credibility, regulatory compliance, and employee confidence in the testing process.

Incomplete or Inaccurate Paperwork

Incomplete or inaccurate paperwork is a frequent issue in drug screen collections. Errors in documentation, such as missing information or incorrect entries, can delay the testing process or even render the results invalid. Utilizing electronic chain-of-custody forms (eCCF) can minimize human error, as eCCFs automate the paperwork process and ensure that all necessary fields are completed correctly before submission. This not only speeds up the collection process but also reduces the risk of errors that could compromise the test results.

Refusals

Refusals at the point of collection are serious and can disrupt the drug testing process. A refusal to test can occur for various reasons, such as a donor failing to appear for the test, leaving the collection site before the process is complete, or failing to provide a specimen without a legitimate medical explanation. Employer only makes final determination on DOT Collections that resulted in the donor leaving the site before the collection concluded.

Additionally, refusal can be marked if a donor does not comply with the direct observation procedures or attempts to adulterate the specimen by wearing a prosthetic device or otherwise interfering with the collection process. Refusals are documented by the collector and reported to the employer’s Designated Employer Representative (DER), who makes the final determination. For non-DOT collections, refusals reported to DISA by a collector are documented between DISA and the collector and processed.

Shy Bladder

One of the most common issues during a urine collection is a "shy bladder" situation, where the donor is unable to provide the required urine sample volume. For Department of Transportation (DOT) collections, the minimum amount required is 45 mL, while for non-DOT collections, it is 30 mL. If a donor initially fails to provide a sufficient sample, the shy bladder procedure is initiated.

This process involves giving the donor up to three hours to produce an adequate specimen, during which they can consume up to 40 ounces of water, reasonably distributed over the time period. It’s important to document this process meticulously in a shy bladder log. If, after three hours, the donor still cannot provide an adequate sample, it is typically considered a refusal to test—unless a medical evaluation finds a legitimate medical reason for the inability to provide a sample. Employers, in coordination with the Medical Review Officer (MRO), are responsible for arranging this medical examination. Employers can ensure more effective Shy Bladder circumstance management by referring donors to collection sites no later than 2 hours before the site closes.

Temperature

Another issue that arises during urinalysis is when the specimen's temperature is outside the acceptable range of 90-100°F. This can indicate that the specimen may have been tampered with or substituted. The temperature of the urine is checked immediately after collection, using a temperature strip on the collection container. If the temperature falls outside the acceptable range, a second collection must be conducted.

For DOT drug testing, this second test must be performed under direct observation to prevent any further tampering. If the donor refuses to proceed with a second collection, it is considered a refusal to test. In this case, no specimen is sent to the lab, but thorough documentation of the refusal is required. If the donor complies with the second collection under direct observation, the results of this collection will be considered the final result, unless the initial specimen tested positive.

Direct Observation

Direct observation during urine collection is mandated in specific circumstances, particularly under DOT regulations. This involves a same-gender observer directly watching the donor provide the specimen to ensure there is no tampering. Situations that necessitate direct observation include a specimen temperature that is out of range or when there is a reason to believe the donor has adulterated the sample. Tests always collected under observation are:

  • DOT Follow Up
  • DOT Return to Duty
  • DISA Contractor Consortium Program Follow Up Tests

The process is highly regulated, with strict guidelines to ensure compliance and maintain the integrity of the test. Collectors must follow the DOT's Direct Observation Procedures, which detail how and when a direct observation should be conducted. The observer must be of the same gender as the donor, and there are no exceptions to this rule.

Insufficient Quantity for Oral Fluid Collections

Oral fluid drug testing is becoming increasingly popular due to its non-invasive nature and quick results. However, challenges arise when there is an insufficient quantity of oral fluid collected. The standard requirement for a valid sample is approximately 1 milliliter (mL) of saliva, with a tolerance of plus or minus 10%.

Most oral fluid collection devices include a volume adequacy indicator, which typically turns blue when the correct volume has been collected. This feature helps ensure that enough saliva is obtained to avoid false negatives due to insufficient sample size. Collectors should always ensure the indicator shows the correct volume before sending the specimen to the lab to prevent delays in testing and potential re-collections.

Insufficient Quantity for Hair Collections (Collection Not Regulated by Part 40)

Hair testing is the only non-regulated collection based on Part 40 collection standards. The collection guidelines are set forth by the testing laboratory. It is often preferred for its ability to detect drug use over a longer period. However, it presents challenges when the donor lacks sufficient hair or when the collector does not gather enough hair for testing. A hair drug test requires about 100 milligrams of hair, equivalent to 90 to 120 strands. The hair must be collected from a single source—either the head or the body (e.g., chest, face, arms, or legs)—but not mixed between different sources.

If the hair is too short or too sparse, the collection could be deemed insufficient, leading to rejection by the laboratory. Collectors should be well-trained in identifying suitable areas for hair collection and in ensuring the amount collected meets laboratory requirements. Collectors should make sure they recollect to collect the right amount of hair. Proper training and adherence to guidelines are crucial to prevent specimen rejection due to inadequate quantity.

Shy Lung

"Shy lung" situations occur during breath alcohol tests when a donor cannot provide an adequate breath sample for analysis. If the medical evaluation determines there is no medical reason for the failure to provide a sufficient breath sample, it is recorded as a refusal to test. Similarly, if the donor refuses to undergo the medical evaluation, it is considered a refusal to test. Proper documentation and adherence to procedures are crucial to maintaining compliance and ensuring the integrity of the testing process.

How DISA Can Help

At DISA Global Solutions, we understand the complexities involved in drug screen collections and the challenges employers face. Our comprehensive suite of services is designed to help organizations streamline their drug testing processes while maintaining compliance with all regulatory requirements. We offer advanced solutions like electronic chain-of-custody forms (eCCF), diverse testing options including urine, hair and oral fluid, and expert guidance on best practices for workplace drug screening. With a vast network of collection sites, DISA ensures convenience and efficiency for employers and employees alike. Our commitment to quality and customer service makes us a trusted partner in helping you create a safer, more productive workplace.

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About DISA Global Solutions

Founded in 1986, DISA is the industry-leading provider of employee screening and compliance services. Headquartered in Houston, with more than 35 offices throughout the U.S. and Canada, DISA’s comprehensive scope of services includes drug and alcohol testing, background screening, occupational health, and transportation compliance. DISA assists employers in making informed staffing decisions while building a culture of safety in their workplace.

DISA Global Solutions aims to provide accurate and informative content for educational purposes only and does not constitute legal advice. The reader retains full responsibility for the use of the information contained herein. Always consult with a professional or legal expert.