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Florida Administrative Code (Last Updated: April 18, 2024) |
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64. Department of Health |
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64E. Division of Environmental Health |
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64E-1. Certification Of Environmental Testing Laboratories |
1(1) 2Except as provided in subsection 764E-1.102(5), 8F.A.C., laboratories shall arrange for and submit to a comprehensive on-site inspection by the DOH’s authorized representatives at least once every two years and at such other times the DOH deems necessary to determine continued compliance with this rule47.
48(2) Inspections will be unannounced in those cases in which the DOH determines this approach necessary to establish compliance.
67(3) The laboratory shall ensure that its Quality Manual, analytical methods, quality control data, proficiency test data, laboratory standard operating procedures, and all records needed to verify compliance with the TNI and NELAC Standards, referenced in rule 10464E-1.0015, 105F.A.C., and this rule are available for review during the on-site laboratory inspection. The laboratory shall allow the DOH’s authorized representatives to examine records; observe the laboratory’s facilities, procedures, and equipment; and interview staff during the on-site inspection.
143(4) Inspections will include onsite proficiency test samples when the DOH is unable to determine compliance using more conventional methods.
163(5) The laboratory shall submit to the 170DOH, or the DOH’s authorized representatives, as applicable, within 30 calendar days of receiving the written on-site inspection report, 189a Plan of Correction 193and estimated completion date 197for each deficiency noted during the on-site 204inspection205. Proposed corrective-action plans 209and completion dates 212must be completed on or attached to the “Statement of Deficiencies and Plan of Correction” form, DH 1137, 23012/16, incorporated 232by reference herein 235and available at 238https://www.flrules.org/Gateway/reference.asp?No=Ref-09906240.
241(6) The 243DOH or its authorized representatives 248may conduct on-site inspections of the laboratory at any time.
258Rulemaking Authority 260381.00591, 261403.0625(3), 262403.863(1), 263(2) FS. Law Implemented 267381.00591, 268403.0625(1), 269(2), (3), 271403.851, 272403.863273(1), (2), 275(3), (7), 277403.8635(1), 278(2) FS. History–New 8-27-86, Amended 10-10-89, 6-29-94, 4-25-96, Formerly 10D-41.105, Amended 4-16-00, 9-26-18.
