| (a) A laboratory that fails to meet requirements may
be placed on provisionally accredited or approved status:
(1) by scoring outside the acceptable limits on a set
of split samples;
(2) by having serious deficiencies at the time of an
onsite inspection; or
(3) by failing to notify the department within 30 days
of major changes which might impair analytical capability (personnel,
equipment, or location).
(b) Failure on two consecutive split samples or failure
to correct major deficiencies following an onsite inspection, within
60 days, may result in the withdrawal of accreditation or approval.
Withdrawal of accreditation or approval shall remain in effect until
measures are taken by the laboratory to attain compliance and an additional
onsite inspection determines that the major deficiencies are corrected
at a time that is agreeable for both parties.
(c) Accreditation or approval may be suspended or revoked
immediately if the minimum standards of the U.S. Food and Drug Administration
require suspension or revocation, or if continued operation of the
laboratory will jeopardize public health.
(d) Accreditation or approval shall be revoked for
a laboratory that submits as its own work the results for analysis
of any split samples that was analyzed by a different laboratory.
The laboratory may not reapply for accreditation or approval for a
period of not less than three years.
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