Florida Regulations 64E-1.104: OnSite Inspections
Current as of: 2024 | Check for updates
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(1) Except as provided in subsection 64E-1.102(5), F.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 rule.
(2) Inspections will be unannounced in those cases in which the DOH determines this approach necessary to establish compliance.
(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 Fl. Admin. Code R. 64E-1.0015, 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.
(4) Inspections will include onsite proficiency test samples when the DOH is unable to determine compliance using more conventional methods.
(5) The laboratory shall submit to the DOH, or the DOH’s authorized representatives, as applicable, within 30 calendar days of receiving the written on-site inspection report, a Plan of Correction and estimated completion date for each deficiency noted during the on-site inspection. Proposed corrective-action plans and completion dates must be completed on or attached to the “”Statement of Deficiencies and Plan of Correction”” form, DH 1137, 12/16, incorporated by reference herein and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-09906.
(6) The DOH or its authorized representatives may conduct on-site inspections of the laboratory at any time.
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, 4-25-96, Formerly 10D-41.105, Amended 4-16-00, 9-26-18.
(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 Fl. Admin. Code R. 64E-1.0015, 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.
(4) Inspections will include onsite proficiency test samples when the DOH is unable to determine compliance using more conventional methods.
(5) The laboratory shall submit to the DOH, or the DOH’s authorized representatives, as applicable, within 30 calendar days of receiving the written on-site inspection report, a Plan of Correction and estimated completion date for each deficiency noted during the on-site inspection. Proposed corrective-action plans and completion dates must be completed on or attached to the “”Statement of Deficiencies and Plan of Correction”” form, DH 1137, 12/16, incorporated by reference herein and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-09906.
(6) The DOH or its authorized representatives may conduct on-site inspections of the laboratory at any time.
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, 4-25-96, Formerly 10D-41.105, Amended 4-16-00, 9-26-18.