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CRI Lab Quality Advisor

Waived Testing: The Last Mountain

Published January 20, 2014 11:08 AM by Irwin Rothenberg

Have you noticed how much more attention waived testing is getting these days?

We know that CLIA has defined waived tests as laboratory procedures which employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; and which pose no reasonable risk of harm to the patient if the test is performed incorrectly. Tests cleared for home use by the FDA are also classified as waived;

We also know that facilities performing only waived tests have no routine oversight and no personnel requirements and are only required to obtain a Certificate of Waiver (CW), and follow manufacturers' test instructions. The latter account for over 70% of all clinical laboratories in the U.S.

As efforts intensify to reduce medical errors, improve health-care quality, and increase patient safety, there is a renewed focus on how to better monitor waived testing. After all, since 1988, the number of CLIA approved waived tests has increased from 8 to 120. Technology has facilitated this growth by enabling the development of ever increasing numbers of test systems that have been approved for the performance of these tests; now numbering over 1400.

As the number of approved analytes for waived testing has increased, the potential for serious impacts on healthcare has also increased. Think of the consequences of incorrect Prothrombin times, Glucose values, electrolytes, and HIV screens for patient care.

The concern is usually not about the kits or instruments themselves, but the human factor: is the testing staff adequately trained and competent to perform the testing as required by the manufacturer? Is quality control monitored, and corrective action taken if needed, before patient results are reported? Are reagents and specimens properly stored? Who is supervising the staff?

Studies have shown a higher level of quality issues in waived only laboratories that were randomly surveyed. These included lack of available written procedures, personnel training and competency assessments, and environmental issues. Qualified oversight of the testing process and personnel competency DOES make a difference.

We are finally beginning to move in the direction of codifying these standards into universal lab practice for all patient testing. For example, COLA, one of the leading laboratory Accreditation Organizations, has added ten new criteria specifically for waived testing. These include requirements for competency testing for staff performing testing at all levels of complexity.

Really, when you think about it, why should a lesser complexity of the testing compromise standards once it is realized that patient care is affected by these results.

Now, the last remaining issue is: how do we adapt these concerns for good laboratory practice into the public arena of non-lab performed waived tests (home use) people are performing in greater numbers, especially as the concept of taking greater control of one’s healthcare becomes technically easier. Obviously this issue goes beyond the traditional laboratory paradigm, and may well be the highest mountain to climb.


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