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Clinical Laboratory Malpractice

Updated on November 8, 2014

Negligence is the failure to use such care that a reasonably prudent and careful person would use under similar circumstances. Potential liability for negligence, is also known as malpractice. There are four elements a claimant, or plaintiff, must prove in a malpractice action:

  • Duty
  • Breach of duty
  • Proximate cause (causal connection)
  • Damages

The plaintiff must prove all four elements by a preponderance of the evidence. In other words, the jury must determine whether in its collective mind, on the basis of the evidence presented, it is more likely than not that the alleged negligence caused injury to the plaintiff, If this is the case, the jury (or court) will determine the amount by which the plaintiff has been damaged.

In 1988, Congress passed the Clinical Laboratory Improvement Amendments (CLIA). Through the CLIA, the Centers for Medicare and Medicaid regulate all laboratory testing (except research) performed on humans in the United States. The CLIA Program, implemented by the Division of Laboratory Services under the Medicaid and State Operations (CMSO), has the primary goal of ensuring quality laboratory testing. The CLIA set forth extensive conditions or standards that laboratories must meet to receive certification from the U. S. Department of Health and Human Services.

Common sources of professional liability for clinical laboratories based on reported Malpractice cases include the following:

  • Error in diagnostic testing for cancer
  • False-positive drug screening reported to employers
  • Unidentified tainted blood products
  • Failure to identify genetic disorders in newborns and pregnancy screening
  • Delay in or failure to transmit laboratory results
  • Use of improper equipment or procedures

As in other areas of healthcare liability, theories of liability evolve as professional standards change. It is incumbent on the practitioners to constantly stay abreast of new standards and regulations, to be familiar with the follow in-house policies and procedures, and to question out-of date practices, equipment, and methodologies.

The Spoliation doctrine has been developing over the past decade as both an evidentiary rule and a source of punishment or sanctions against defendants and their attorneys who lose or destroy evidence or alter records. Spoliation is defined as the intentional destruction of evidence that, when established, enables and the court to instruct the jury that it may infer that the lost or damaged evidence was unfavorable to the party responsible for the spoliation. It includes “the destruction or the significant and meaningful alteration of a document or instrument.”

The expert witnesses are generally required to establish the applicable standard of care in laboratory malpractice actions, as they do in other medical malpractice cases. The testimony of an expert in clinical laboratory science or other related disciplines is necessary to explain the technical and scientific data that a lay jury need to identify the appropriate standard of care and to determine whether that standard has been breached.

An exception to the expert testimony requirement, know as the “common knowledge” exception. This exception applies where “the defendant’s negligence is so grossly apparent or the treatment is so common that a lay person can readily appraise it using his everyday knowledge”


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