Current through August 26, 2024
(1) ADMINISTRATIVE PROCEDURES. A laboratory's
accreditation is valid until it expires, is suspended, or is revoked. If, after
opportunity for a contested case hearing, the department finds that an
accredited laboratory materially and consistently failed to comply with the
provisions of this chapter, the department may suspend or revoke a laboratory's
accreditation in whole or in part by matrix, analytical technology, method,
analyte, or analyte group. Contested case hearings for out-of-state
laboratories regulated under this chapter shall be held in Madison, Wisconsin.
(2) SUSPENSION OR REVOCATION OF
CERTIFIED LABORATORIES.
(a) Causes for
suspension of certification include any of the following:
1. Material and consistent failure to comply
with the requirements of this chapter.
2. Reporting data to the department after a
laboratory is deemed temporarily incapable of performing analysis in any
matrix, analytical technology, method, analyte, or analyte group.
3. Suspension of certification,
accreditation, license, or approval by another state or agency of the federal
government for which the laboratory holds certification if the grounds for
suspension are substantially equivalent to any of those listed in this
paragraph.
(b) Causes
for revocation of certification include any of the following:
1. Material and consistent failure to
maintain records as required in this chapter.
2. Failure to allow the department to perform
on-site evaluations as specified in subch. VI.
3. Material and consistent failure to comply
with the requirements of this chapter.
4. Material and consistent failure to submit
requested records to the department.
5. Material and consistent failure to follow
specified procedural or quality control requirements prescribed in
methods.
6. Falsification of
analytical results, testing dates, or any other information submitted to the
department by the laboratory. Falsification includes alteration or modification
of a certificate.
7. Failure of two
consecutive PT samples for any method and analyte or analyte group combination
for laboratories holding certification in the drinking water matrix.
8. Revocation of certification, registration,
accreditation, license, or approval by another state or agency of the federal
government for which the laboratory holds certification if the grounds for
revocation are substantially equivalent to any of those listed in this
paragraph.
(3) REVOCATION OF REGISTERED LABORATORIES.
Causes for revocation of registration include any of the following:
(a) Material and consistent failure to
maintain records as required in this chapter.
(b) Failure to allow the department to
perform on-site evaluations as specified in subch. VI.
(c) Material and consistent failure to comply
with the requirements of this chapter.
(d) Material and consistent failure to submit
requested records to the department.
(e) Material and consistent failure to follow
specified procedural or quality control requirements prescribed in approved
methods.
(f) Falsification of
analytical results, testing dates, or any other information submitted to the
department by the laboratory. Falsification includes alteration or modification
of a certificate.
(4)
PROCEDURE FOR SUSPENSION OR REVOCATION OF ACCREDITATION.
(a) An order suspending or revoking
accreditation shall be mailed to the laboratory and shall state the reasons for
suspension or revocation. The order shall include the conditions under which
reapplication will be accepted. For orders suspending accreditation, the order
may include a timetable for correcting the deficiencies that led to the
suspension. For orders revoking accreditation, the department may set a time
for the revocation.
(b) An order
suspending or revoking an accreditation shall take effect on the 30th day after
the order is mailed unless the owner of an accredited laboratory submits a
petition for a hearing. Petitions for a hearing shall be submitted to the
department within 30 days of receiving the order. The petition for hearing
shall specify the findings or conclusions, or both, that the laboratory
disputes and conform to the requirements of s.
NR 2.05(5).
(c) If a request for a hearing is submitted
and meets the requirements of s.
227.42, Stats.,
the suspension or revocation shall be stayed, and the department shall conduct
a contested case hearing on the matter. At least ten days prior to the date of
the hearing, the department shall send a written notice to the laboratory
indicating the date, time, and location of the hearing. The final determination
of the department, including the basis for the decision, shall be provided by
written order to the laboratory after the hearing.
Note: Refer to ch. NR 2 for additional
information on the contested hearing process.
(d) The final determination of the department
is subject to review under ch. 227, Stats.
(5) REAPPLICATION FOLLOWING SUSPENSION OR
REVOCATION.
(a) A laboratory that has had its
accreditation suspended may reapply for accreditation if all the following are
met:
1. The deficiencies that led to the
suspension have been corrected in accordance with the timetable contained in
the order.
2. Any conditions for
reapplication specified in the order have been met.
(b) A laboratory that has had its
accreditation revoked may reapply for accreditation if all of the following
have been met:
1. The deficiencies that led to
the revocation have been corrected.
2. Conditions contained in the order have
been satisfied.
3. The time for
which the revocation is in effect has expired.
(c) Laboratories reapplying for accreditation
following suspension or revocation shall submit an initial application as
identified in s.
NR 149.14(1) and
(2).
(6) REFERRAL.
(a) Any violation of this chapter may be
referred to the attorney general's office for enforcement under ss.
299.95 and
299.97,
Stats.
(b) Any laboratory operating
without proper accreditation for which analysis results are submitted to the
department for compliance monitoring or for analyses that require certification
or registration under any covered program may be referred by the department to
the attorney general's office for enforcement.