(a) A laboratory found to be in conforming status,
with noted nonconformities, has up to 90 days to successfully correct
all nonconformities noted in the evaluation. After this period, the
laboratory's status will be downgraded to nonconforming if any key
nonconformities remain to be successfully corrected. As a result,
data being generated by the laboratory will no longer be acceptable
for use in support of the National Shellfish Sanitation Program.
(b) A laboratory found to be in provisionally conforming
status has up to 60 days to successfully correct all nonconformities
noted in the evaluation. After this period, the laboratory's status
will be assigned to one of the following.
(1) Conforming status if all critical and key nonconformities
have been successfully corrected.
(2) Nonconforming status if any critical or key nonconformities
remain to be successfully corrected. As a result, data generated by
the laboratory will no longer be acceptable for use in support of
the National Shellfish Sanitation Program.
(c) A laboratory found to be in nonconforming status
has up to 30 days to demonstrate successful correction of all nonconformities
found. After this period, the laboratory's status will be assigned
to one of the following.
(1) Conforming status if all critical and key nonconformities
have been successfully corrected.
(2) Nonconforming status if any critical or key nonconformities
remain to be successfully corrected. As a result, data generated by
the laboratory will no longer be acceptable for use in support of
the National Shellfish Sanitation Program.
(d) If a laboratory is found to be in nonconforming
status for failure to successfully implement the required corrective
action, or for having repeated critical or key nonconformities in
consecutive evaluations, then the department will ensure that an action
plan is developed to correct the situation in an acceptable and expeditious
manner or discontinue use of the laboratory to support the National
Shellfish Sanitation Program.
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