Fla. Admin. Code Ann. R. 64E-1.102 - Certification Requirements
(1) An
application for certification shall be made in writing to the Except for
inspections conducted for the purposes of contract oversight of the DOH
contract assessment providers, the DOH on Form DH 1762, December 2016,
"Application for Certification of Environmental Testing Laboratories," which is
herein incorporated by reference and is available at
https://www.flrules.org/Gateway/reference.asp?No=Ref-09905.
This application must be accompanied by the application fee. The laboratory
must arrange for proficiency testing results from the three most recent testing
round attempts to be submitted directly to the DOH by the recognized
proficiency test provider.
(2)
Separate application and certification shall be required for all laboratories
maintained on separate premises even though operated under the same management;
however, separate certification is not required for separate buildings on the
same or adjoining grounds.
(3) An
application is not completed until the laboratory has fulfilled all of the
following requirements:
(a) The application
reviewed by the DOH was found to contain all the information required in Form
DH 1762, "Application for Certification of Environmental Testing Laboratories,"
December 2016, referenced in subsection (1), above.
(b) Proficiency test samples are successfully
analyzed in two of the most recent three testing rounds attempted, if available
from a recognized proficiency testing provider, as required in rule
64E-1.106,
F.A.C.
(c) An on-site laboratory
inspection has been conducted for the Fields of Accreditation for which the
laboratory is seeking certification, as required in rule
64E-1.104,
F.A.C.
(d) All applicable fees are
paid as required in rule
64E-1.007,
F.A.C.
(4) An
out-of-state laboratory shall be eligible for reciprocal certification
provided:
(a) The laboratory is certified by
a National Environmental Laboratory Accreditation Program (NELAP) recognized
Accreditation Body for those Fields of Accreditation in which the laboratory is
requesting certification pursuant to this rule,
(b) The laboratory submits to the DOH the
application and fee required in subsection (1), above,
(c) The laboratory submits to the DOH a
current copy of the laboratory's unexpired certification from the NELAP
Accreditation Body and the certifying agency's analyte sheet showing those
Fields of Accreditation for which the laboratory is certified.
(5) If upon review of the
documents listed in subsection (4), above, the DOH determines that the
application process is complete and that the laboratory is already certified by
its NELAP-recognized primary Accreditation Body for the same Fields of
Accreditation requested on its application, the DOH will not require an on-site
survey and certification will be granted after the laboratory pays all
applicable fees.
(6) If upon review
of the documents listed in subsection (4), above, the DOH is unable to
determine that the out-of-state certification program is equivalent to the
requirements of this rule, the DOH or its authorized representatives will
conduct an on-site inspection.
(7)
A laboratory is not eligible for certification for any Fields of Accreditation
available through the NELAP-recognized Accreditation Body of the state where
the laboratory is physically located, unless the laboratory applies for
reciprocal certification under subsection (4), above.
(8) All certified or applicant laboratories
will be responsible for the expenses incurred by the DOH or its authorized
representatives for any on-site inspection.
(9) The laboratory must report to the DOH's
Bureau of Public Health Labs (BPHL) within 30 calendar days of the change all
significant changes relevant to its certification, including but not limited to
its legal, organizational, commercial, or ownership status; the organization,
top management, and key personnel; main policies; resources and premises; its
certified Fields of Accreditation; and other such matters that may affect the
laboratory's ability to fulfill the requirements of this rule.
Notes
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.
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