(a) InAs ordera to be used for alcohol screening tests subject to this partlaboratory, ayou non-evidentialmust screeninguse devicethe shallcutoff haveconcentrations anfor approved quality assurance plan (QAP) developed by the manufacturerinitial and approvedconfirmation byadulterant thetesting Nationalas Highwayrequired Trafficby Safety Administration (NHTSA).
(1) The plan shall designate the methodHHS orMandatory methodsGuidelines to be used to perform quality control checks; the temperatures at which the non-evidential screening device shall be stored and used,you asmust welluse astwo otherseparate environmentalaliquots—one conditionsfor ( e.g., altitude, humidity) that may affect the performanceinitial oftest the device; and, whereanother relevant,for the shelfconfirmation life of the devicetest.
(2b) TheAs QAP
a
shall
laboratory,
prohibit
you
the
must
use
report
of
results
any
at
device
or
that
above
does not pass
the
specified
cutoffs
quality control checks or that has passed its expiration date.
(
b) The manufacturers’ instructions on
or
included in the package
for
each
pH,
saliva
at
testing
or
device
above
shall
or
include
below
directions on
the
proper use of the device
values
,
the
as
time
appropriate)
frame
as
within
adulterated
which
and
provide
the
device
numerical
must
value
be
that
read
supports
and
the
manner
adulterated
in which the reading is made
result
.
(c)
[73
The
FR
employer
35970,
and
June
its
25,
agents shall comply with the QAP and manufacturer's instructions for each non-evidential screening device it uses for alcohol screening tests subject to this Part.
2008]
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