Florida Regulations 64E-1.106: Proficiency Testing Requirements
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(1) Applicant and certified laboratories shall participate in a proficiency testing program, also known as Performance Evaluation, from a TNI-accredited provider. The list of accredited Proficiency Testing Providers and the tabular listing of analytes available for proficiency testing by matrix, delineated as NELAP Fields of Proficiency Testing, are available at http://www.nelac-institute.org. Participation means that the laboratory will analyze and report to the provider the results of all proficiency test samples required by the approved program for which the laboratory desires and maintains certification. Laboratories certified or seeking certification for Fields of Accreditation in the Drinking Water Matrix category group must also comply with Performance Evaluation requirements in Title 40 Code of Federal Regulations sections 141.23(k)(3), 141.24(f)(17), 141.24(h)(19), 141.89(a)(1), and 141.131(b)(2), 07-01-2016 edition, which are incorporated by reference, and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-09907.
(2) Laboratories shall bear the cost of any subscription to a proficiency testing program required by the DOH for compliance purposes. The DOH shall not be charged a fee for the analysis of any proficiency testing samples.
(3) Unless associated with the submittal of an application form as provided in subsection 64E-1.102(1), F.A.C., the laboratory must authorize the provider, on or prior to the testing round closing date, to submit the proficiency testing results to the DOH concurrently with the submittal of these results to the laboratory. After the closing date, no modification to any aspect of the reported results, method/technology, measurement units, or the associated report information shall be made unless it is necessary due to a documented error made by the accredited proficiency testing program provider.
(4) All Fields of Accreditation within each Matrix category group for which a laboratory is certified or is pending certification must be satisfactorily analyzed, if available, on two of the most recent three proficiency testing rounds attempted. Proficiency test sample results shall be considered satisfactory when they are within the acceptance limits established by the accredited proficiency test sample provider. If a laboratory reports more than one result for a Field of Proficiency Testing on a proficiency testing round, any unsatisfactory result constitutes a failed testing attempt for the corresponding certified or pending Field of Accreditation.
(5) A laboratory that meets the requirements of subsection (4) of this rule for a particular Field of Proficiency Testing is eligible for obtaining and maintaining certification for the corresponding Field of Accreditation. Otherwise, certification shall be denied, suspended, or revoked for that Field of Accreditation.
(6) A laboratory shall participate in at least two testing rounds from a recognized proficiency test sample provider per calendar year, with no more than seven months between consecutive testing rounds in terms of closing dates for each proficiency testing attempt, for each available Field of Proficiency Testing that corresponds to a pending or certified Field of Accreditation.
(7) The laboratory shall comply with all requirements in Volume 1, Module 1 of the TNI Standards, referenced in Fl. Admin. Code R. 64E-1.0015, in analyzing proficiency test samples. In addition, the laboratory shall not submit proficiency test sample results generated by another laboratory facility as its own.
(8) Proficiency test sample providers shall report laboratory results for proficiency test samples in compliance with the reporting requirements of Section 11 of Volume 3, “”General Requirements for Environmental Proficiency Test Providers,”” (EL-V3-2009) of the TNI NELAP, which is incorporated by reference. This document may be examined and inspected at the Florida Department of State, Room 701, The Capitol, Tallahassee, Florida 32399-0250 and at the Florida Department of Health, Bureau of Public Health Laboratories, 1217 North Pearl Street, Jacksonville, Florida 32202. The agency has determined that posting this publication on the internet for purposes of public inspection and examination would constitute a violation of federal copyright law.
(9) In addition to the requirements in subsections (1) through (8), above, laboratories certified or seeking certification for Fields of Accreditation in the Drinking Water Matrix category group for the Microbiology category for total coliforms and E. coli must receive acceptable scores for both the total coliforms and for E. coli portions of a proficiency testing round for performance on those Fields of Accreditation in that testing round to be considered acceptable. Acceptable scores are determined using the “”Fields of Proficiency Testing Tables,”” January 2018, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-09908.
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-41.107, Amended 4-16-00, 6-30-03, 1-24-05, 9-26-18
(3) Unless associated with the submittal of an application form as provided in subsection 64E-1.102(1), F.A.C., the laboratory must authorize the provider, on or prior to the testing round closing date, to submit the proficiency testing results to the DOH concurrently with the submittal of these results to the laboratory. After the closing date, no modification to any aspect of the reported results, method/technology, measurement units, or the associated report information shall be made unless it is necessary due to a documented error made by the accredited proficiency testing program provider.
(4) All Fields of Accreditation within each Matrix category group for which a laboratory is certified or is pending certification must be satisfactorily analyzed, if available, on two of the most recent three proficiency testing rounds attempted. Proficiency test sample results shall be considered satisfactory when they are within the acceptance limits established by the accredited proficiency test sample provider. If a laboratory reports more than one result for a Field of Proficiency Testing on a proficiency testing round, any unsatisfactory result constitutes a failed testing attempt for the corresponding certified or pending Field of Accreditation.
(5) A laboratory that meets the requirements of subsection (4) of this rule for a particular Field of Proficiency Testing is eligible for obtaining and maintaining certification for the corresponding Field of Accreditation. Otherwise, certification shall be denied, suspended, or revoked for that Field of Accreditation.
(6) A laboratory shall participate in at least two testing rounds from a recognized proficiency test sample provider per calendar year, with no more than seven months between consecutive testing rounds in terms of closing dates for each proficiency testing attempt, for each available Field of Proficiency Testing that corresponds to a pending or certified Field of Accreditation.
(7) The laboratory shall comply with all requirements in Volume 1, Module 1 of the TNI Standards, referenced in Fl. Admin. Code R. 64E-1.0015, in analyzing proficiency test samples. In addition, the laboratory shall not submit proficiency test sample results generated by another laboratory facility as its own.
(8) Proficiency test sample providers shall report laboratory results for proficiency test samples in compliance with the reporting requirements of Section 11 of Volume 3, “”General Requirements for Environmental Proficiency Test Providers,”” (EL-V3-2009) of the TNI NELAP, which is incorporated by reference. This document may be examined and inspected at the Florida Department of State, Room 701, The Capitol, Tallahassee, Florida 32399-0250 and at the Florida Department of Health, Bureau of Public Health Laboratories, 1217 North Pearl Street, Jacksonville, Florida 32202. The agency has determined that posting this publication on the internet for purposes of public inspection and examination would constitute a violation of federal copyright law.
(9) In addition to the requirements in subsections (1) through (8), above, laboratories certified or seeking certification for Fields of Accreditation in the Drinking Water Matrix category group for the Microbiology category for total coliforms and E. coli must receive acceptable scores for both the total coliforms and for E. coli portions of a proficiency testing round for performance on those Fields of Accreditation in that testing round to be considered acceptable. Acceptable scores are determined using the “”Fields of Proficiency Testing Tables,”” January 2018, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-09908.
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-41.107, Amended 4-16-00, 6-30-03, 1-24-05, 9-26-18