ASK THE EXPERT
Barry Craig, MLT (NCA), CLC
Lab Coordinator, CHS
Member POCCA (Point of Care Coordinators Alabama)
Member Helena Laboratories Focus Group
I
keep hearing different rumors about
Waived testing and changes that may
be coming. What have you heard?
Ah, the rumor mill. The fastest way to
transmit rumors is not broadband or
paper, it is voice.
Here is what I know. Waived testing has
snowballed into a monstrous industry. When
this happens, government regulation is never
far behind. Some of the ideas for changes that
are being considered:
1. Requiring Proficiency Testing for Waived
tests – This I do not necessarily think is a bad
idea. Twice a year you would receive specimens
that mimic patient specimens. You would run
the tests in the same manner as you run your
patients, then mark an answer sheet and mail it
back in. You would be graded on your
performance since the specimens have been
doctored to produce known results. These tests
measure not only the test method, but the
employee running the test. This idea is being
considered but is receiving a lot of push back
from the testing industry.
2. Requiring personnel standards for
training and competency – This would require
written documentation of training to perform
the test and then periodic competency
evaluations to insure continued competency
in performing the testing. By the way, #1 can
be used as part of the competency evaluation.
I believe this being added as a requirement is
likely to happen in the future.
3. Manufacturers being required to take a
stricter stance on Quality Control
requirements – The only requirements for
Quality Control under CLIA for Waived testing
are that you follow the manufacturer’s
guidelines. These guidelines are sometimes
vague and do not use definitive terms. They
say things like “suggest” and “recommend”
when it comes to QC, instead of “required”. I
believe this being added as a requirement is
likely to happen in the future as well.
I feel the lab space we use in our office is
inadequate. We have almost no room to
process specimens and it gets very hot in
there. I have tried to talk to the doc about it
but it falls on deaf ears. Any thoughts or
suggestions?
Traditionally the lab sometimes ends up as
an afterthought. This is true in physician
offices all the way up to large healthcare
systems. But maintaining adequate space and
environment is part of the CLIA regulations
and is also part of all other accreditation
agencies regulations as well.
The Federal Register says:
493.1252Standard: Test systems,
equipment, instruments, reagents,
materials, and supplies.(a) Test systems must
be selected by the laboratory. The testing must
be performed following the manufacturer's
instructions and in a manner that provides test
results within the laboratory's stated
performance specifications for each test system
as determined under § 493.1253.(b) The
laboratory must define criteria for those
conditions that are essential for proper storage
of reagents and specimens, accurate and
reliable test system operation, and test result...
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