False Positives, Real Consequences: The Scary Reality of Faulty Lab Results
The accuracy of lab testing.
The basic assumption when taking a test is that the test should give credit for giving the correct answer. If the question is what is 2+2 and you respond 4, you should get credit. If the test gives credit for answering “63,” then there’s something wrong with the test, not your math skills. Specifically, there’s something wrong with how the test processes answers.
The stakes are raised when it comes to drug testing. If you give a clean sample, the drug test should come back clean. If it doesn’t there’s a problem. Potentially a big one because drug tests are used to make employment, probation, custody, and liability (like in a car accident) decisions.
Drug testing procedures
Drug testing using mass spectrometry relies on precise scientific methods to ensure accurate and reliable results. Mass spectrometry identifies and quantifies unknown substances, such as drugs, by analyzing their molecular weight. To achieve accurate measurements, the testing process requires the creation of a calibration curve at the start of each test run. This curve is established using six calibrators, or control samples, that contain known concentrations of the target substance, known as the analyte. The calibration curve is essential for interpreting the presence and concentration of the analyte in unknown samples.
The calibration curve is not only a requirement but also a key quality control tool. According to the standards set by CAP-FDT (College of American Pathologists Forensic Drug Testing) Certification, a calibration curve must be freshly prepared for each test run and used alongside quality controls to ensure the accuracy of the results. If errors occur during the calibration process, such as incorrect measurements or faulty equipment, these issues must be identified and corrected before proceeding.
Common fixes may include cleaning the machine, adjusting reagents, or recalibrating test solutions.
An important component of mass spectrometry testing is the use of internal standards (IS), which are substances added to both control and unknown samples in known amounts. The IS serves as a reference point, ensuring that the test is accurately measuring the analyte. If the IS is not detected properly, the entire test is considered invalid, and the sample should be retested.
Any manipulation or failure to correctly apply these scientific controls, including using calibration data from previous runs, compromises the integrity of the results. Proper calibration and control procedures are crucial for preventing false positives or false negatives, which can have significant consequences for individuals relying on the accuracy of drug testing.
The scheme
Avertest, LLC, a forensic drug testing company based in Richmond, VA, and which does business nationwide under the name Averhealth, does drug testing. Avertest claimed that its tests were 97% accurate. But the forensic toxicologist who ran Avertest’s lab claimed that up to 30 percent of the company’s test results were incorrect. She claimed that Avertest was cutting corners to with its quality control procedures and that its testing procedures did not meet industry standards.
Avertest allegedly took several shortcuts in its drug testing process, undermining the accuracy and integrity of its results. One major issue involved the improper use of calibration curves. In mass spectrometry, calibration curves are essential for interpreting the presence and concentration of substances in test samples. Avertest allegedly failed to create new calibration curves for each test run, as required. Instead, it regularly used “historical” calibration curves from previous runs, sometimes days or weeks old, to interpret current test results. This is scientifically flawed because calibration curves from different runs are not interchangeable and must be specific to each batch of tests. Using old calibration data introduces significant errors, much like comparing "apples to oranges."
Furthermore, even when calibration curves were used in the same run, Avertest allegedly manipulated the data. This included altering the regression of the calibration curve, changing the internal standards (IS), and using historical quality controls. Internal standards, added in known amounts to each sample, serve as a reference to ensure accurate measurements. Failing to properly apply or detect the internal standards invalidates the test results. However, Avertest allegedly bypassed these quality control measures, continuing with tests despite flawed or missing data.
Additionally, Avertest reportedly did not include the required 10% of quality control samples in each batch, which is a violation of CAP-FDT (College of American Pathologists Forensic Drug Testing) Certification standards. This failure to maintain adequate controls further compromised the accuracy of the testing process.
These shortcuts in calibration, quality control, and internal standards could result in false positives or false negatives, affecting the lives of individuals whose test results were used in critical decisions, such as child custody cases or employment.
Potential consequences
Vice reported that the consequences were potentially significant. According to their story, Alexandra Hodor, a 33-year-old single mother of three, got clean after overdosing on heroin, but Avertest’s drug tests frequently returned positive results for cocaine. Hodor initially lost custody of her children after overdosing on heroin, a substance she used to cope with PTSD following a traumatic pregnancy and delivery. After being revived with Narcan, Michigan’s Department of Health and Human Services launched an investigation into abuse and neglect, prompting Hodor to seek sobriety. She turned her life around by attending parenting and substance abuse classes, working as a waitress, and pursuing a social work degree. However, despite her efforts, her attempts to reunite with her children were hindered by weekly random drug tests that showed her as using cocaine.
The penalty
Avertest has agreed to pay $1,344,621 to settle allegations that it knowingly violated the False Claims Act (FCA) by submitting to the Michigan Department of Health and Human Services (MDHHS) improper claims for payment for drug tests.
As the U.S. Attorney commented:
“Averhealth failed to meet its commitments to MDHHS yet continued to claim entitlement to payment for its nonconforming services. This outcome highlights our Office’s continued commitment to hold accountable any business or person who is dishonest in their dealings with programs funded by the Federal Government.”
The whistleblower
Dr. Riley will receive $228,586 as part of the settlement. Under the qui tam provision of the False Claims Act, a private party (also referred to as a whistleblower or relator) may file an action on behalf of the United States and receive a portion of the recovery, typically between 15-30%.
If you think you’ve observed fraud or misconduct, we can evaluate your options. Vivek Kothari is a former federal prosecutor who represents whistleblowers. For a free consultation, contact Vivek by email, phone, Signal, or fill out the contact form.