Section 149.10. Enforcement.

 

(1)   Administrative procedures. A laboratory's certification is valid until it expires, is suspended, or revoked. A laboratory's registration is valid until it expires or is revoked. If, after opportunity for a contested case hearing, the department finds that a certified or registered laboratory materially and consistently failed to comply with the provisions of this chapter, the department may suspend or revoke a laboratory's certification or revoke a laboratory's registration by whole or in part by matrix, analytical technology, or analyte or analyte group. Contested case hearings for out-of-state laboratories regulated by 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 quality program requirements as specified in subch. VII .

2. Reporting data to the department after a laboratory is deemed temporarily incapable of performing analysis in any matrix, analytical technology, or 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 quality program requirements as specified in subch. VII .

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 approved 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 2 consecutive proficiency testing samples for any method and analyte or analyte group combination for laboratories holding certification in the drinking water matrix.

8. Demonstrated incompetence manifested by the chronic inability to meet the requirements of this chapter.

9. 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) 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

(b) Material and consistent failure to maintain records as required in this chapter.

(c) Material and consistent failure to comply with the quality program requirements as specified in subch. VII .

(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) Demonstrated incompetence manifested by the chronic inability to meet the requirements of this chapter.

(4)   Procedure for suspension or revocation of certification or revocation of registration .

(a) An order suspending or revoking certification or revoking registration 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 certification, the order may include a timetable for correcting the deficiencies that led to the suspension. For orders revoking certification or registration, the department may set a time period for the revocation.

(b) An order suspending or revoking a certification or revoking a registration shall take effect on the thirtieth day after the order is mailed, unless the owner of a certified or registered 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, which 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 10 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.

(d) The final determination of the department is subject to review under ch. 227 , Stats.

(5)   Reapplication following suspension revocation.

(a) A laboratory which has had its certification suspended may reapply for certification or registration if all of 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 which has had its certification or registration revoked may reapply for certification or registration 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 period for which the revocation is in effect has expired.

(c) Laboratories reapplying for certification or registration 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 certification or registration for which analysis results are submitted to the department for compliance monitoring or for analyses which require certification or registration under ch. NR 662 , 664 or 665 , may be referred by the department to the attorney general's office for enforcement.

History: CR 06-005 : cr. Register April 2008 No. 628 , eff. 9-1-08.

Note

Refer to ch. NR 2 for additional information on the contested hearing process. Microsoft Windows NT 6.1.7601 Service Pack 1