Labs In Court

A roundup of recent cases and enforcement actions involving the diagnostics industry

Case: CMS revoked an Arizona lab’s CLIA certification in 2000. Three unsuccessful appeals and one failed petition to the U.S. Supreme Court later—eight years in total—the seven CLIA deficiencies, which the lab owner continued to insist were invalid, remained unremedied and the $30,000 fine unpaid. In 2013, the owner sought new CLIA certification for the lab but the state refused to process the application unless and until the owner paid the fine and resolved the previous sanctions. A new round of appeals ensued and the case landed in an Arizona federal district court which ruled against the owner.

Analysis: The CLIA law establishes a specific process for appealing the denial of certification under which a lab must first go to an Administrative Law Judge (ALJ) before it can go to federal court. But I’m not asking for new CLIA certification, the owner argued, just reinstatement of the old one. The court didn’t buy it. CMS didn’t temporarily suspend the lab’s CLIA certification back in 2000, it permanently revoked it. As a result, this was a new application and the owner had to follow the CLIA appeals process and take its case to the ALJ.

[Ali v. United States HHS, 2020 U.S. Dist. LEXIS 110998]

 Failure to Redo “Error” Message A1c Test on Diabetic Patient ≠ No-Brainer Medical Malpractice

 Case: A patient with Type 2 diabetes presented to a federal health clinic with normal heart function, clear lungs and no swelling. And since he didn’t complaint about light-headedness or dizziness, the examining doctor ordered relatively simple bloodwork, namely, a basic metabolic panel and A1c test, which measures average glucose level over a three-month period. The A1c test returned an “error” result, indicating that there was something wrong with the way the test was performed, e.g., air bubbles in or too small a blood sample or a bad cartridge. But the doctor saw no reason to keep the patient and discharged him without repeating the test. Right after being discharged, the patient wrapped his car around a telephone pole wrecking the vehicle and his back. He claimed he blacked out and sued the clinic for medical malpractice in botching the test. The clinic moved to dismiss the case without a trial and the New York federal district court granted the motion.

Significance: Rule: To prove medical malpractice, the plaintiff needs at least one expert witness. Exception: Expert testimony isn’t required if the medical malpractice is so obvious that a layperson can tell it occurred, e.g., a doctor amputates the wrong leg. Since the patient apparently couldn’t find an expert witness to testify on his behalf, he contended that discharging him without redoing the A1c test after an “error” message qualified as the obvious kind of malpractice that you don’t need a doctor to recognize. But the court disagreed:

  • The A1c test was irrelevant to a discharge decision because it doesn’t measure current glucose levels;
  • The “error” result just meant the test went wrong and said nothing about the patient’s glucose levels;
  • Since the patient wasn’t in any distress, the doctor’s decision not to repeat it was reasonable.

[Moore v. United States, 2020 U.S. Dist. LEXIS 92729]

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