10
STRATEGIES NECESSARY TO
ACHIEVE QUALITY WAIVED TESTING
By Irwin Z. Rothenberg, MBA, MS, CLS(ASCP), Technical Writer /Quality Advisor, COLA Resources, Inc.
The Clinical Laboratory Improvement Amendments of 1988
(CLIA 88) created the concept of waived tests which are defined
as tests that are so simple to perform, and produce accurate
results so reliably, as to render the likelihood of erroneous results
negligible; and which also pose no reasonable risk of harm to
the patient even if the test is performed incorrectly. Thus, these
tests are exempt from federal requirements for personnel
qualification, training, and competency assessment; quality
control (except as specified by the manufacturer), proficiency
testing, quality assessment, and the need for routine inspection
As a result, laboratory professionals have long expressed concern
about the quality of testing performed in these laboratories. This
concern has only grown with the rapid proliferation of waived tests,
along with point of care /remote testing sites.
Quality Concerns
As a response to these concerns, both CMS and the CDC
conducted random surveys of waived laboratories several years
after CLIA 88 was enacted. These labs had significant quality
issues, including the lack of available written procedures;
adequate personnel training, quality control performed as
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required; also, the lack of a proper attention to reagent
expiration dates and storage requirements; and the failure to
enter test results into electronic medical records. Although
not usually specified in the product insert (and therefore not a
CLIA requirement), proper documentation and record-
keeping of patient and testing information are also important
elements of good laboratory practices.
Among the waived laboratories surveyed, the study also
found:
• High staff turnover
• Lack of formal laboratory education
• Limited training in test performance and quality assessment
Strategies to Address These Concerns
I. Competent Management and Organization
To be effective, efforts to achieve quality waived testing
through good lab practice must start even before the testing
process, all the way back to assessing the laboratory structure,
organization, and purpose. These include:
A. Commitment to Constant Oversight of the
Testing Process
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