62-160.650. Field and Laboratory Audits

(1) The Department and agencies or individuals with delegated authority from the Department shall conduct audits of field and laboratory procedures and/or records to determine if approved protocols are being followed as required and to ensure data are being generated in compliance with the requirements of this chapter.

(2) An audit shall consist of one or more of the following:

(a) An on-site assessment of field sampling and/or laboratory procedures;

(b) A review, assessment and/or validation of data associated with a Department program activity;

(c) The submission of performance samples (e.g., blind, split and/or performance check samples) to an organization for subsequent use in the evaluation of that organization’s technical performance associated with a specific Department project or program activity; or

(d) Other relevant information as specified in a Department contract, order, permit or Title 62 rules.

(3) Upon request, the audited field sampling organization, individual consultant or responding party shall provide copies of all applicable records as specified in Rule 62-160.240, F.A.C. Sufficient information shall be provided to enable the auditor to independently reconstruct all field procedures related to the project.

(4) Upon request, the audited laboratory, individual consultant or responding party shall provide copies of those applicable records as specified in Rule 62-160.340, F.A.C. Sufficient information shall be provided to enable the auditor to independently reconstruct all laboratory procedures related to the project.

(5) Within ninety (90) days of the audit, the Department shall provide a preliminary audit report to the audited field sampling or laboratory organization, individual, consultant or responding party (“audited party”). The audited party shall have forty-five (45) days thereafter to respond with a detailed plan of corrective actions and an implementation schedule for the deficiencies that were noted in the preliminary audit report; justification for noted deficiencies that will not be addressed or corrected; and any corrections or rebuttals to the audit findings. If different than the above, the Department shall specify in rules, contracts, orders or permits any alternative schedules and procedures for the distribution of preliminary audit reports to designated recipients and for any required corrective action plans or other responses from designated respondents.

(6) Failure to respond with a plan of corrective action or to additional requests by the Department for a plan of corrective action shall result in a recommendation to the affected program that the data not be used.

(7) Once a response has been received, the Department shall evaluate the response for technical applicability and completeness. The Department will issue a final response to the audited party and any affected organization or individual that specifies acceptance or rejection of the audited party’s plan of corrective actions, provides recommendations concerning the usability of the audited data, and includes a statement of any substantially affected person’s rights under Chapter 120, F.S. If different than the above, the Department shall specify in rules, contracts, orders or permits any alternative schedules and procedures for the distribution of the Department’s final response to designated recipients, to include acceptance or rejection of the audited party’s plan of corrective actions, recommendations concerning the usability of the audited data and any other relevant information. Any substantially affected organization or person (e.g., field sampling or laboratory organization, individual, consultant, responding party, permittee, or facility owner/operator) may request an administrative hearing as provided in Chapter 120, F.S., within 21 days of receipt of the final response.

(8) The requirements in subsections 62-160.650(4) through 62-160.650(7), F.A.C., shall not apply to field proficiency audits of organizations or persons conducting field bioassessment procedures according to DEP SOPs BRN 1000, LVI 1000, SCI 1000, subpart FS 7460 in FS 7000, or FT 3000, which are incorporated by reference in subparagraphs 62-160.800(1)(c)1.-3., 62-160.800(1)(a)16., and 62-160.800(1)(a)30., F.A.C., respectively. However, subsections 62-160.650(4) through 62-160.650(7), F.A.C., shall apply to audits of laboratory macroinvertebrate taxonomy procedures and documentation.

Rulemaking Authority 403.061, 403.0623 FS. Law Implemented 373.026, 373.309, 373.409, 373.413, 373.414, 373.416, 373.4592, 376.303, 376.305, 376.3071, 403.0623, 403.0625, 403.087, 403.088, 403.0881, 403.504, 403.704, 403.707, 403.722, 403.853 FS.  History–New 1-1-91, Formerly 17-160.650, Amended 3-24-96, 4-9-02, 12-3-08, 7-30-14, 4-16-18.