Laboratory Testing

With Waived Testing, Quality Must be Job One

Though uncomplicated to perform, waived tests can still result in errors if staff members are not trained.

Waived tests – simple point-of-care laboratory tests that are exempt from most federal and state oversight – are widely viewed as having little or no potential to cause harms to patients. They are straightforward to perform, and can be administered by staff with little or no specialized laboratory background.

Now used to test for a wide variety of diseases and conditions – such as drug abuse, glucose levels, pregnancy and influenza – waived testing is steadily on the increase, now encompassing 120 waived analytes and more than 4,000 waived testing systems. More than 70 percent of the nearly 235,000 laboratory testing sites in the United States today have a Certificate of Waiver from the Clinical Laboratory Improvement Amendments (CLIA) if 1988.

But, despite the growing use of waived tests – and the popular view that they are virtually “error-proof” – problems are occurring at some waived sites. Federal government research is showing that failure to adhere to something as simple as following the directions in a waived test package insert can result in testing errors. This, in turn, has the potential to affect the quality of patient care. With more than 165,000 waived labs, the impact of waived testing errors on the patient population is cause for concern – even with CMS’s ongoing random surveillance of these sites…(Read More Here)

Interim Guidance for Specimen Collection, Transport, Testing, and Submission for Persons Under Investigation for Ebola Virus Disease in the United States

Check out this article for laboratorians and other healthcare personnel handling specimens for Ebola testing

Key Points

  • U.S. clinical laboratories can safely handle specimens from these potential Ebola patients by taking all required precautions and practices in the laboratory, specifically designed for pathogens spread in the blood.
  • Risk assessments should be conducted by each laboratory director, biosafety officer, or other responsible person to determine the potential for sprays, splashes, or aerosol generated during laboratory procedures.
  • Any person collecting specimens from a patient with suspected Ebola virus disease should wear appropriate PPE.
  • Anyone collecting specimens from a patient should follow the procedures below for transporting them through the healthcare facility, clean-up of spills, storing, packaging and shipping to CDC for testing.

Learn More Here