FAC §9153: (a) A person shall not establish, operate, or maintain a laboratory that provides services in the examination, diagnosis, analysis, testing, quantifying, or identification of any emergency or regulato

(a) A person shall not establish, operate, or maintain a laboratory that provides services in the examination, diagnosis, analysis, testing, quantifying, or identification of any emergency or regulatory condition of poultry and livestock unless the person obtains a certificate from the department pursuant to this article authorizing the person to establish, operate, and maintain a laboratory that provides these services, except as specified in Section 9152.5. (b) A person who desires a certificate pursuant to this section shall file an application with the department for a certificate accompanied by the application fee required pursuant to Section 9154. (c) The application shall be on a form prescribed and furnished by the department. (d) The department shall issue a certificate to an applicant if the department is satisfied that the applicant is documented and verified to have full accreditation and to be in good standing with the American Association of Veterinary Laboratory Diagnosticians or International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) 17025 current general requirements for the competence of testing and calibration laboratories. (e) A certificate shall expire one year after the date of issuance. A certificate shall be renewed upon payment of the renewal application fee required pursuant to Section 9154 if the applicant is in compliance with this article and the regulations adopted pursuant to this article. (f) A certified laboratory shall use an official nationally approved or validated diagnostic test for diseases of regulatory importance. A certified laboratory may request permission from the department to use a nonapproved or nonvalidated test. (g) A certified laboratory shall report positive and suspect positive test results only to the party who provided the original sample and shall also report the test results as required by Section 9101 or any other law.