Lack of Federal Regulations Causes Preventable Lab Test Mistakes and Diagnostic Errors

Like many medical products, lab tests are strictly regulated by the government – or are they?  While diagnostic laboratories are theoretically required to comply with stringent federal laws, such as the Federal Food, Drug, and Cosmetic Act (FD&C), in practice, the FDA frequently declines to enforce compliance with these regulations which are so critical to public health and safety.  Instead, many laboratories comply only with a set of regulations known as the Clinical Laboratory Improvement Amendments, or CLIA.  Unfortunately, the minimum CLIA standards aren’t very rigorous – and as a result, lab testing and diagnostic errors have become a widespread problem throughout the United States.  

FDA Report: CLIA Compliance Not Enough to Protect Patient Safety

In November 2015, the federal government published a comprehensive FDA report citing nearly two dozen examples of “problematic LDTs” (Laboratory Developed Tests).  The reason these LDTs are described as “problematic” is that they are fraught with inaccuracies and deficiencies, as we’ll explore in just a few moments.

The report argues that, were these CLIA-regulated LDTs subject to greater FDA oversight and held to higher standards, they would produce more accurate results – and in turn, patients would receive more accurate medical diagnoses.  As the FDA points out, “Compliance with CLIA regulation alone does not ensure that the diagnostic devices themselves are safe and effective…  Moreover, the routine CLIA survey does not include a review of the clinical validation of a[n] LDT – that is, the accuracy with which the test identifies, measures, or predicts the presence or absence of a clinical condition or predisposition in a patient.”

Despite the fact that many CLIA-regulated LDTs are rife with shortcomings which present serious diagnostic concerns for patients, their use has risen steadily over the past several decades as their medical applications have broadened.  During the 1970s, LDTs were used primarily to diagnose “rare diseases and conditions in small numbers of patients.”  Today, however, they are used to diagnose many of the most common diseases and disorders in the United States, including but not limited to…

Lyme Disease, Breast Cancer, and Ovarian Cancer: False Positives and Negatives

Lab test accuracy can be measured by two variables: sensitivity, which measures a test’s ability to accurately identify patients who are condition-positive, and specificity, which measures a test’s ability to accurately identify patients who are condition-negative.  For this reason, sensitivity is sometimes referred to as the “true positive rate,” while specificity is called the “true negative rate.”  When a test detects a disease in a patient who is actually healthy, it is called a “false positive.”  When the opposite is true, and a test fails to detect disease in a patient who is ill, it is called a “false negative.”

The FDA report cited the following as examples of tests which frequently yield false positives:

• Antigen and Culture Test
  • Diagnoses – Lyme Disease
  • Problem – “Large numbers of patients with positive tests do not have Lyme disease.”  As the report points out, this problem was serious enough to merit a CDC warning in 2014, which cited widespread issues with “laboratory contamination and the potential for misdiagnosis.”

• OvaCheck and OvaSure
  • Diagnose – Ovarian Cancer
  • Problem – There are two separate (and serious) issues with OvaCheck and OvaSure tests: not only did the FDA find “no validation that [either] test predicts or detects ovarian cancer,” which is obviously a huge issue – it also cited “inflated [accuracy] claims by the manufacturer.”

At the opposite end of the spectrum, the FDA found that the Oncotype DX HER2 RT-PCR test, which is used to detect breast cancer, is impaired by “poor sensitivity,” meaning it produces a high rate of false negative results.  According to the report, as many as 20% of DX HER2 tests for breast cancer are inaccurate.  

The FDA also warned against the following lab tests:

• BrafV600E Mutation Tests
• CARE Clinics BioMarkers
• Duke University Chemotherapy Assessment
• Omapro Companion Diagnostic
• OncoVue
• Prolaris
• Target Now
• XMRV-Chronic Fatigue Syndrome (CFS) Test

The FDA’s final conclusion?  “Despite arguments from some that ‘CLIA is enough,’ all of the tests described as problematic in this report were offered from laboratories following the minimum requirements of CLIA.”  Based on this assessment, it would seem that CLIA really isn’t enough after all.  

Legislators should move to impose greater regulations on LDTs – but until that day, patients across the country continue to face a heightened risk of serious diagnostic errors.  These serious laboratory diagnostic errors and mistakes can have serious and long lasting consequences to victims and their families.

If you, a family member or friend suffered a misdiagnosis or delayed diagnosis because of lab testing errors at a clinical laboratory in Maryland, you may be entitled to compensation, which can help cover your medical bills and lost earnings, and provide compensation for your injuries and emotional distress, while providing a greater degree of financial security for you and your loved ones.  To talk about your case in a free and confidential consultation, contact the laboratory malpractice attorneys of Whitney, LLP at (410) 583-8000 today, or use our Quick Contact form to send an email. An attorney will contact you to begin your free Case Consultation.