Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-1 - CERTIFICATION OF ENVIRONMENTAL TESTING LABORATORIES › Section 64E-1.106 - Proficiency Testing Requirements

Current through Reg. 50, No. 138; July 16, 2024
(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 rule
				 64E-1.0015, F.A.C., 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.
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