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Investigative report shines light on medical laboratory errors

Milwaukee Journal Sentinel story cites improperly labeled samples, lack of maintenance on test equipment, and improper refrigeration techniques among the reasons behind incorrect test results that put patients at risk.

This is a stock image of a medical laboratory facility.
This is a stock image of a medical laboratory facility.

The Milwaukee Journal Sentinel newspaper’s two-part investigational series, “Hidden Errors/A Watchdog Report,” shines a light on medical laboratory failures that put patients at risk.

The series was published in the Kenosha News, which ran the story May 17 and 18. The story's Author Ellen Gabler reports, “Everyone assumes lab results are correct.” Yet, the story notes, “from drug screens to vital medical tests, [a] secretive system hides lab problems from the public.”

Gabler writes that private accrediting organizations police laboratories on behalf of the federal government. Yet, she says the Milwaukee newspaper’s investigation, “has found that some of these accrediting organizations are failing to cite serious violations that put patients’ health and lives at risk.”

A video within the story explains what can go wrong with a laboratory test. Errors can be traced to labs not following basic protocols that ensure test result accuracy, labs not following regulations, inspection results that are kept hidden, samples that are not properly labeled or collected, samples that are not kept refrigerated, lab testing equipment that is not properly maintained, etc.

An infographic from the report says, “Lab tests influence 70% of medical decisions. With seven billion to 10 billion tests done each year in the U.S., even a small error rate affects millions of patients.” The results of these errors can devastate lives. The investigative report provided several examples of the personal impact caused by laboratory-related errors.

What follows are links some laboratory test/regulatory resources:

FDA’s Laboratory Developed Tests

ASTM Intl. Laboratory Testing Standards

The Journal of the American Medical Assn.: FDA Regulation of Laboratory-Developed Diagnostic Tests: Protect the Public, Advance the Science

General Notices and Requirements Applying to Standards, Tests, Assays, and Other Specifications of the U.S. Pharmacopeia

 

 

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