93.12 Laboratories, approval of.

(1) It is the purpose of this section to assure the reliability and quality of manual and automated laboratory examinations made for the protection of the health of the public.

(2) Any laboratory that is established and operated to perform bacteriological or microscopic examinations of milk, water and food products for the purpose of protecting the health of the public shall apply to the department for an evaluation of the examinations and appropriate certification.

(3) The department shall designate which laboratory examinations it deems necessary for the protection of the health of the public. Substantial failure of any laboratory to show evidence of quality control procedures, sufficient to comply with current standards and practice as prescribed by the department, shall result in denial or revocation of the certificate of approval. The department shall provide for consultation on laboratory methods and procedures.

(4) The department, after conducting an evaluation for each specialty area and after receiving a fee for each specialty area from the laboratory, shall issue a certificate of approval to the laboratory covering those examinations which have met the minimum standards established by the department. The department shall issue an interim certificate of approval for an approved laboratory that applies for initial certification, which shall be valid for the remainder of the calendar year for which it is issued. Certification renewals shall be issued on a calendar-year basis. Specialty fees for certification of an initially certified laboratory and a certified laboratory that applies to expand its current certification with newly established specialties shall be prorated at one-twelfth of the annual fee for each month remaining in the calendar year for which the certificate of approval is issued. A certificate of approval shall be revoked by the department if the minimum standards established by the department for certification are not met within 2 successive evaluations. Fees collected under this subsection shall be credited to the appropriation under s. 20.115 (1) (gb).

(5) The department shall establish uniform minimum standards to be used in the evaluation and certification of laboratory examinations. The department shall submit any rules proposed under this subsection which affect the laboratory certification program under s. 299.11 to the department of natural resources and to the state laboratory of hygiene for review and comment. These rules may not take effect unless they are approved by the department of natural resources within 6 months after submission.

(6) Laboratories required to apply to the department under sub. (2) shall not operate without a certificate of approval. Any lab which operates without a certificate of approval shall be fined not less than $100 nor more than $1,000. Each day such violation continues shall constitute a separate offense.

(7) The department shall promulgate rules establishing a fee schedule to offset the cost of the certification of laboratories and the collection of fees under sub. (4).

(8) The department shall enter into a memorandum of understanding with the department of natural resources setting forth the responsibilities of each department in administering the laboratory certification programs under sub. (5) and s. 299.11. The memorandum of understanding shall include measures to be taken by each department to avoid duplication of application and compliance procedures for laboratory certification.

(9) The department shall recognize the certification or registration of a laboratory by the department of natural resources under s. 299.11 and shall accept the results of any test conducted by a laboratory certified or registered to conduct that category of test under that section.

History: 1975 c. 39, 198, 224; 1977 c. 29; 1979 c. 34; 1981 c. 291; 1983 a. 410; 1991 a. 178; 1993 a. 16; 1993 a. 27 s. 303; Stats. 1993 s. 252.22; 1995 a. 27 ss. 6324g to 6324k; Stats. 1995 s. 93.12; 1995 a. 227.