Fatal Flaws and the Consequences of a Cancelled Test

Posted on Wednesday, March 23rd, 2022

By Adam Hall

This information is provided for educational purposes only. Reader retains full responsibility for the use of the information contained herein.

Workplace drug testing programs have been around for years, and while they remain a critical tool for employers in creating safe work environments for employees, certain aspects of the overall process have inherent issues. Collections are often at that heart of those issues.

More specifically, the collection process relies heavily on the competency and accuracy of the collector. Mistakes are made frequently, and while many mistakes can be fixed by completing a memorandum of correction, some errors are serious enough that they cause the test to be cancelled. These egregious mistakes, commonly referred to as “fatal flaws,” result in a cancelled test. Employers must know what steps to take when they receive a cancelled test notification.

What is a Fatal Flaw?

Before we discuss what steps an employer should take upon receiving a cancelled test notification, let’s take a closer look at what constitutes a fatal flaw during the collection process. According to 49 CFR Part 40 (Part 40), which is the federal regulation that governs how drug testing must be conducted for federal employees, the following scenarios are considered fatal flaws:

No Chain of Custody Form (CCF) accompanies the sample to the lab
The CCF arrives at the lab without a sample even though a sample was collected
The collector’s printed name and signature are omitted from the CCF
Two separate collections are performed using one CCF
The specimen ID numbers on the sample bottles do not match the numbers on the CCF
The specimen bottle seals are broken, or appear to be tampered with
There is an insufficient volume of urine to complete testing

It is important to understand that federal regulations do not govern all drug testing; however, Part 40 is often regarded as the industry standard when it comes to what is considered a fatal flaw. Non-regulated testing certainly provides more opportunity to correct potentially fatal flaws as laboratories are not necessarily required to adhere to strict federal regulations. This does not mean that there are never fatal flaws at a non-federal level. Laboratories will often give guidance to collectors or collection facilities if corrections can be made.

What Happens if a Fatal Flaw is Committed?

Once a fatal flaw is committed, employers will usually receive a cancelled test notification. Employers then need to determine what the next steps are based on the reason for the test. In most cases, an employer must have a final result, whether positive or negative. What this means is that the donor will need to take a new test in order to achieve this outcome, usually for pre-employment, post-accident, or reasonable suspicion reasons for testing.

Conversely, if a random test is cancelled due to a fatal flaw, an employer may not be authorized to retest that employee based on the applicable governing regulations. To clarify further, under federal regulations, if an employee’s random test is cancelled due to a collector error, the employer may not subject that individual to a retest.

Employers need to be aware of the rules and regulations they must adhere to prior to making any retest decision.

Why Else Can a Drug Test Be Cancelled?

Outside of fatal flaws committed due to collector error, a drug test may be cancelled for other reasons. For example, if a laboratory determines that a sample is invalid for any reason, it is likely that they will reject the sample for testing. This usually will be reported to a Medical Review Officer (MRO), who will then report the cancelled test outcome to the employer accompanied with further instruction for retesting. Depending on what regulations, policies, or guidelines an employer is responsible for adhering to, it is important that they are aware of the rules and requirements pertaining to cancelled tests.

Cancelled tests are problematic to employers as they often lead to retests, increased costs, time delays, or other inconveniences associated with fatal flaws. The competency of a collector or collection facility is not something that can be controlled by the employer, so it is important to understand how to handle a cancelled test.

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