Florida Regulations 64E-1.102: Certification Requirements
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(1) An application for certification shall be made in writing to the Except for inspections conducted for the purposes of contract oversight of the DOH contract assessment providers, the DOH on Form DH 1762, December 2016, “”Application for Certification of Environmental Testing Laboratories,”” which is herein incorporated by reference and is available at https://www.flrules.org/Gateway/reference.asp?No=Ref-09905. This application must be accompanied by the application fee. The laboratory must arrange for proficiency testing results from the three most recent testing round attempts to be submitted directly to the DOH by the recognized proficiency test provider.
(2) Separate application and certification shall be required for all laboratories maintained on separate premises even though operated under the same management; however, separate certification is not required for separate buildings on the same or adjoining grounds.
(3) An application is not completed until the laboratory has fulfilled all of the following requirements:
(a) The application reviewed by the DOH was found to contain all the information required in Form DH 1762, “”Application for Certification of Environmental Testing Laboratories,”” December 2016, referenced in subsection (1), above.
(b) Proficiency test samples are successfully analyzed in two of the most recent three testing rounds attempted, if available from a recognized proficiency testing provider, as required in Fl. Admin. Code R. 64E-1.106
(c) An on-site laboratory inspection has been conducted for the Fields of Accreditation for which the laboratory is seeking certification, as required in Fl. Admin. Code R. 64E-1.104
(d) All applicable fees are paid as required in Fl. Admin. Code R. 64E-1.007
(4) An out-of-state laboratory shall be eligible for reciprocal certification provided:
(a) The laboratory is certified by a National Environmental Laboratory Accreditation Program (NELAP) recognized Accreditation Body for those Fields of Accreditation in which the laboratory is requesting certification pursuant to this rule,
(b) The laboratory submits to the DOH the application and fee required in subsection (1), above,
(c) The laboratory submits to the DOH a current copy of the laboratory’s unexpired certification from the NELAP Accreditation Body and the certifying agency’s analyte sheet showing those Fields of Accreditation for which the laboratory is certified.
(5) If upon review of the documents listed in subsection (4), above, the DOH determines that the application process is complete and that the laboratory is already certified by its NELAP-recognized primary Accreditation Body for the same Fields of Accreditation requested on its application, the DOH will not require an on-site survey and certification will be granted after the laboratory pays all applicable fees.
(6) If upon review of the documents listed in subsection (4), above, the DOH is unable to determine that the out-of-state certification program is equivalent to the requirements of this rule, the DOH or its authorized representatives will conduct an on-site inspection.
(7) A laboratory is not eligible for certification for any Fields of Accreditation available through the NELAP-recognized Accreditation Body of the state where the laboratory is physically located, unless the laboratory applies for reciprocal certification under subsection (4), above.
(8) All certified or applicant laboratories will be responsible for the expenses incurred by the DOH or its authorized representatives for any on-site inspection.
(9) The laboratory must report to the DOH’s Bureau of Public Health Labs (BPHL) within 30 calendar days of the change all significant changes relevant to its certification, including but not limited to its legal, organizational, commercial, or ownership status; the organization, top management, and key personnel; main policies; resources and premises; its certified Fields of Accreditation; and other such matters that may affect the laboratory’s ability to fulfill the requirements of this rule.
Rulemaking Authority 381.00591, 403.0625(3), 403.863(1), (2) FS. Law Implemented 381.00591, 403.0625(1), (2), (3), 403.851, 403.863(1), (2), (3), (7), 403.8635(1), (2) FS. History-New 8-27-86, Amended 10-10-89, 6-29-94, 2-13-96, 4-25-96, Formerly 10D-41.103, Amended 4-16-00, 6-30-03, 1-24-05, 9-26-18.
Terms Used In Florida Regulations 64E-1.102
- Contract: A legal written agreement that becomes binding when signed.
- Oversight: Committee review of the activities of a Federal agency or program.
(3) An application is not completed until the laboratory has fulfilled all of the following requirements:
(a) The application reviewed by the DOH was found to contain all the information required in Form DH 1762, “”Application for Certification of Environmental Testing Laboratories,”” December 2016, referenced in subsection (1), above.
(b) Proficiency test samples are successfully analyzed in two of the most recent three testing rounds attempted, if available from a recognized proficiency testing provider, as required in Fl. Admin. Code R. 64E-1.106
(c) An on-site laboratory inspection has been conducted for the Fields of Accreditation for which the laboratory is seeking certification, as required in Fl. Admin. Code R. 64E-1.104
(d) All applicable fees are paid as required in Fl. Admin. Code R. 64E-1.007
(4) An out-of-state laboratory shall be eligible for reciprocal certification provided:
(a) The laboratory is certified by a National Environmental Laboratory Accreditation Program (NELAP) recognized Accreditation Body for those Fields of Accreditation in which the laboratory is requesting certification pursuant to this rule,
(b) The laboratory submits to the DOH the application and fee required in subsection (1), above,
(c) The laboratory submits to the DOH a current copy of the laboratory’s unexpired certification from the NELAP Accreditation Body and the certifying agency’s analyte sheet showing those Fields of Accreditation for which the laboratory is certified.
(5) If upon review of the documents listed in subsection (4), above, the DOH determines that the application process is complete and that the laboratory is already certified by its NELAP-recognized primary Accreditation Body for the same Fields of Accreditation requested on its application, the DOH will not require an on-site survey and certification will be granted after the laboratory pays all applicable fees.
(6) If upon review of the documents listed in subsection (4), above, the DOH is unable to determine that the out-of-state certification program is equivalent to the requirements of this rule, the DOH or its authorized representatives will conduct an on-site inspection.
(7) A laboratory is not eligible for certification for any Fields of Accreditation available through the NELAP-recognized Accreditation Body of the state where the laboratory is physically located, unless the laboratory applies for reciprocal certification under subsection (4), above.
(8) All certified or applicant laboratories will be responsible for the expenses incurred by the DOH or its authorized representatives for any on-site inspection.
(9) The laboratory must report to the DOH’s Bureau of Public Health Labs (BPHL) within 30 calendar days of the change all significant changes relevant to its certification, including but not limited to its legal, organizational, commercial, or ownership status; the organization, top management, and key personnel; main policies; resources and premises; its certified Fields of Accreditation; and other such matters that may affect the laboratory’s ability to fulfill the requirements of this rule.
Rulemaking Authority 381.00591, 403.0625(3), 403.863(1), (2) FS. Law Implemented 381.00591, 403.0625(1), (2), (3), 403.851, 403.863(1), (2), (3), (7), 403.8635(1), (2) FS. History-New 8-27-86, Amended 10-10-89, 6-29-94, 2-13-96, 4-25-96, Formerly 10D-41.103, Amended 4-16-00, 6-30-03, 1-24-05, 9-26-18.