AB758: Bill Text

AB758,12,2 (d) Quality control. The department shall establish by rule minimum requirements for a quality control program that ensures that a laboratory complies with criteria for the accuracy and precision of tests and that specifies procedures to be followed if these criteria are not met. A laboratory shall conduct self-audits and shall establish a quality control program that is consistent with criteria specified by rule by the department based on the standards of the national environmental laboratory accreditation conference. The department may accept a quality control program based on federal requirements for similar test categories.

AB758,12,6 (e) Records. If a particular time period is not otherwise specified by law, the department may prescribe by rule the length of time that laboratory analysis records and quality control data specified in the laboratory's quality control program are to be retained by the laboratory.

AB758,12,8 (f) Issuance of accreditation. The department shall issue an accreditation to a laboratory for a specified test if the laboratory meets all of the following conditions:

AB758,12,10 1. The laboratory submits an application, on a form provided by the department, requesting accreditation for a specified test.

AB758,12,12 2. The laboratory specifies a methodology prescribed or permitted under par. (b) that it intends to utilize in conducting the test.

AB758,12,15 3. If the department requires a proficiency testing sample, the laboratory conducts a test on the sample and obtains results that comply with the minimum acceptance criteria for the specified test.

AB758,12,18 4. The laboratory has or agrees to implement a quality control program that meets minimum requirements under par. (d) for the specified test and that is to commence no later than the date of accreditation.

AB758,12,22 5. The laboratory allows a representative of the department to perform an on-site assessment to evaluate compliance with the criteria established under par. (am) and resolves any deviations from those criteria that are identified during the assessment.

AB758,12,24 (g) Interim accreditation. The department may grant interim accreditation to a laboratory that meets the conditions in par. (f) 1. to 4.

AB758,13,3 (h) Accreditation period. Accreditation of a laboratory shall be renewed annually. Accreditation is valid from the date of issuance until it expires, is revoked or is suspended.

AB758,13,7 (hm) Interim accreditation period. Interim accreditation expires one year after the date on which the laboratory meets all of the conditions specified in par. (g). Interim accreditation is valid until it expires, is revoked, is suspended or is superseded by accreditation after compliance with par. (f) 5.

AB758,13,17 (i) Suspension and revocation. After considering recommendations from the council, the department shall establish by rule criteria and procedures for the review and evaluation of the accreditation of laboratories and the suspension or revocation of accreditation. If, after opportunity for a contested case hearing, the department finds that an accredited laboratory has falsified results or has materially and consistently failed to comply with the criteria and procedures provided under par. (d), the department may suspend or revoke the accreditation of the laboratory. A person whose accreditation is suspended or revoked may reapply for accreditation upon a showing that the person meets the applicable criteria for accreditation and has corrected the deficiencies that led to the suspension or revocation.

AB758, s. 36 Section 36. 299.11 (8) (title) and (a) of the statutes are amended to read:

AB758,14,2 299.11 (8) (title) Registration Certification procedure. (a) Criteria. Upon application, the After considering recommendations by the council, the department shall promulgate rules establishing uniform minimum criteria, as provided in this subsection, to be used to evaluate laboratories for certification. The department shall register certify a laboratory if the laboratory complies with the requirements of this subsection, if the laboratory does not perform tests commercially for hire, if the laboratory performs tests solely in connection with ch. 283 and if one of the following applies:

AB758,14,4 1. The laboratory performs tests solely on its own behalf or on behalf of a subsidiary or other corporation under common ownership or control; or.

AB758,14,7 2. The laboratory is owned or controlled by a municipality or 2 or more municipalities and performs tests solely on behalf of the municipality or municipalities in test categories specified by the department by rule.

AB758, s. 37 Section 37. 299.11 (8) (b) to (e) of the statutes are amended to read:

AB758,14,11 299.11 (8) (b) to (e) Methodology. Testing by a registered certified laboratory conducted in connection with a covered program shall be carried out in accordance with sub. (7) (7m) (b).

AB758,14,21 (c) Reference sample testing. The department may require by rule reference sample tests test results, that comply with minimum criteria for accuracy for a test, upon application and annually thereafter. If results from these tests do not meet minimum criteria established by rule, the department may require additional reference sample testing. If the laboratory participates in a joint or split sampling program with the federal environmental protection agency, or otherwise obtains independent reference samples, the department may accept those results instead of its own reference samples The department shall publish lists of approved providers of reference samples for tests that are to be regularly and routinely performed by certified laboratories.

AB758,15,3 (d) Quality control. The laboratory shall conduct self-audits and shall establish a quality control program consistent with criteria specified by rule by the department and based on methods and standards prescribed by rule and considering criteria used by the federal environmental protection agency, the American Society for Testing and Materials, the national council on air and stream improvement, the national academy of sciences or any other equivalent agency or organization recognized by the department.

AB758,15,7 (e) Records. Where If a particular time period is not otherwise specified by law, the department may prescribe by rule for each test category the length of time that laboratory analysis records and quality control data specified in the laboratory's quality control program are to be retained by the laboratory.

AB758, s. 38 Section 38. 299.11 (8) (er) of the statutes is created to read:

AB758,15,11 299.11 (8) (er) Issuance of certification. The department shall issue a certification to a laboratory for a specified test category if the laboratory meets all of the following conditions:

AB758,15,13 1. The laboratory submits an application, on a form provided by the department, requesting certification in a specified test category.

AB758,15,15 2. The laboratory specifies a methodology prescribed or permitted under par. (b) that it intends to utilize in conducting tests in the specified test category.

AB758,15,18 3. If the department requires a reference sample test result, the laboratory conducts a test on an approved reference sample and obtains results that comply with the minimum criteria for accuracy for the specified test category.

AB758,15,21 4. The laboratory has or agrees to implement a quality control program that meets minimum requirements under par. (d) for the specified test category and that is to commence no later than the date of certification.

AB758,16,2 5. The laboratory allows a representative of the department to perform an on-site evaluation to determine compliance with the criteria under par. (a) and resolves any deviations from those criteria and standards that are identified during the evaluation, except that the department may waive this condition if a laboratory has previously had a successful on-site evaluation for similar tests or test categories.

AB758, s. 39 Section 39. 299.11 (8) (f) to (h) of the statutes are amended to read:

AB758,16,6 299.11 (8) (f) Registration Certification period. Registration Certification of laboratories shall be renewed annually. A registration certification is valid from the date of issuance until it expires, is revoked or is suspended.

AB758,16,15 (g) Suspension or revocation of registration certification. If, after opportunity for a contested case hearing, the department finds that a registered certified laboratory has falsified results or has materially and consistently failed to comply with the self-audit procedures and quality control programs provided in under par. (d), it may suspend or revoke the registration certification of the laboratory. A person whose registration certification is suspended or revoked may reapply for registration certification upon a showing that the person meets the applicable criteria for registration certification and has corrected the deficiencies that led to the suspension or revocation.

AB758,16,18 (h) Certification Accreditation option. A laboratory which that is otherwise eligible to seek registration certification may elect to apply for certification accreditation under sub. (7) (7m).

AB758, s. 40 Section 40. 299.11 (9) of the statutes is amended to read:

AB758,16,22 299.11 (9) Fees. The department shall promulgate by rule a graduated schedule of fees for accredited, certified and registered laboratories which are designed to recover the costs of administering this section.

AB758, s. 41 Section 41 . 299.11 (9) of the statutes, as affected by 1999 Wisconsin Act .... (this act), is amended to read:

AB758,17,3 299.11 (9) Fees. The department shall promulgate by rule a graduated schedule of fees for accredited, and certified and registered laboratories which are designed to recover the costs of administering this section.

AB758, s. 42 Section 42. Effective dates. This act takes effect on the day after publication, except as follows:

AB758,17,11 (1) The treatment of sections 93.12 (9) (by Section 4 ), 299.07 (1) (a) 11. (by Section 8) and 299.11 (1) (b) (by Section 13 ), (3) (by Section 21 ), (4) (title) (by Section 23), (a) (by Section 23 ) and (c) (by Section 25 ), (5) (title) (by Section 27 ), (b), (c) and (d) (by Section 31 ), (6) (by Section 33 ), (7), (8) (title), (a), (b) to (e), (er) and (f) to (h) and (9) (by Section 41 ) of the statutes and the repeal of section 299.11 (1) (g) of the statutes take effect on July 1, 2001.

AB758,17,12 (End)