Waived testing is one of the fastest growing markets in clinical laboratory testing. Test systems which have been granted a waiver under the Clinical Laboratory Improvement Amendments (CLIA) have grown to include over 90 different analytes. The explosion of available waived tests has prompted many in the industry to question the traditional definition of waived testing as “simple to perform” AND posing “insignificant risk of erroneous results.” The larger healthcare community needs to take a second look at how we talk about waived testing.

Recently, the FDA granted the first-ever waiver for rapid screening test for syphilis making the test available in a variety of nontraditional laboratory settings including, physicians’ offices, emergency rooms, and other health care facilities. A CLIA waiver, particularly in the case of infectious diseases, is truly a remarkable and positive development. Increased access to these tests will likely result in higher rates of detection, diagnosis, and treatment for serious infectious diseases.

But unfortunately, in the December 15, 2014 FDA Press Announcement stated that “The waiver also allows untrained health care workers to perform the tests on patients.” I can’t help but to cringe at reading those words. It is extremely misleading and potentially harmful to assume that waived testing can be performed by “untrained” personnel. While there are no specific educational requirements for an individual to perform waived tests, any person performing those tests still needs to be trained on not only how to perform that test but also on (to name a few):

  • Pre-analytic factors and specimen acceptability
  • Intended use of the test system
  • Performance and interpretation of Quality Control
  • Universal precautions and safe work practices
  • How to process required confirmatory testing

To illustrate this point, many rapid influenza tests are categorized as waived.  The correct sample for many of these tests is a nasopharyngeal (NP) swab.  Someone who has not been trained on how to collect an NP swab may not realize that it is different than a nasal swab.  Yet, accurate use of this test requires a correctly collected NP swab.  Another example is the spun microhematocrit test.   While simple in nature, this test does require the individual performing the test to be able to identify a clot in a capillary tube, and to understand how to use the mircrohematocrit wheel. Without proper knowledge and training on the pre-analytic, analytic, and post-analytic processes, healthcare staff cannot perform waived testing with accuracy and quality.

Referring to those who can perform waived testing as untrained” personnel perpetuates the dangerous belief that waived testing has little or no chance of erroneous results and no impact on patients if performed incorrectly. The 2005 CDC Morbidity and Mortality Weekly Report (MMWR) report Good Laboratory practices for Waived Testing Sites indicates one of the significant factors leading to errors in testing and poor patient outcomes is inadequate training.

The CDC website even directly states “Some waived tests have potential for serious health impacts if performed incorrectly….To decrease the risk of erroneous results, the test needs to be performed correctly, by trained personnel and in an environment where good laboratory practices are followed.”

Quality in waived testing is dependent upon a focused emphasis on training and competency of testing personnel. There have been some highly publicized cases of patient harm and even death related to erroneous waived testing such as glucose.  This alone should be a call to the lab community to insist that waived testing be “put under a microscope.” But, it is equally important to focus on gaining community trust in public health screening initiatives by making training and competency for waived testing personnel a top priority.

After all, No one wants to see a notation on their lab test report “performed by untrained personnel.”