Waived Testing: The Last Mountain
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
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.
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.
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.