Florida Regulations 62-160.670: Data Validation by the Department
Current as of: 2024 | Check for updates
|
Other versions
(1) All data generated for Department activities are subject to data verification and data validation to determine if the data are suitable and usable for a specified purpose. Data shall be verified and validated based on the assessment of the following:
(a) Completeness of the Department requested data package(s) and the response of involved parties to any Department requests for additional data;
(b) Integrity of samples as determined by complete and proper sample transmittal documentation, and records that demonstrate adherence to proper preservation, transport or other sample handling protocols, as applicable;
(c) Proper use of sample collection methods;
(d) Proper selection and use of analysis methods;
(e) Sufficient use and routine evaluation of quality control measures to establish the precision, accuracy, sensitivity, selectivity, and potential bias associated with the analytical system and associated results;
(f) Proper instrument calibration and verification procedures;
(g) Documentation of all generated data as provided in Rules 62-160.240 and 62-160.340, F.A.C.;
(h) Ability to reconstruct all field sampling and laboratory procedures through the documentation and records of the laboratory or field sampling organization as provided in Rules 62-160.240 and 62-160.340, F.A.C.;
(i) Ability to trace data in the final report to a specific sampling site, date and time;
(j) Status of the laboratory’s certification through the DOH ELCP as provided in Fl. Admin. Code Chapter 64E-1, for any given analyte or category of analytes; and,
(k) Appropriateness of the collected data as related to the specific data quality objectives of the Department program activity or project for which they were collected including those data being considered for secondary use.
(2) The Department will evaluate data according to the criteria in paragraphs (a) through (k) above, and determine if the data are usable.
(3) In addition to subsection (2) above, the Department shall also evaluate data according to the following:
(a) The outlined in the Department’s document “”Department of Environmental Protection Process for Assessing Data Usability (DEP-EA-001/07),”” dated March 31, 2008, which is incorporated by reference in Fl. Admin. Code R. 62-160.800
(b) The description of data quality objectives and criteria for data usability assessments for the Stream Condition Index (SCI) or a BioRecon determination, as discussed in DEP-SAS-001/11, which is incorporated by reference in Fl. Admin. Code R. 62-160.800(2)(e), and the Lake Vegetation Index (LVI), as discussed in DEP-SAS-002/11, which is incorporated by reference in Fl. Admin. Code R. 62-160.800(2)(f)
(4) If the audited data were originally generated for a specific purpose but are being considered for a secondary use for another purpose (secondary use), and the Department determines from the evaluation process, as described in subsections 62-160.670(2) and 62-160.670(3), F.A.C. above, that the data do not meet the data quality objectives for the secondary use, the Department will recommend that the data not be used by the program that is considering the secondary use. The recommendation not to use secondary data does not impact the usability or validity of the data for the program for which the data were originally intended.
Rulemaking Authority 403.061, 403.0623 FS. Law Implemented 373.026, 373.309, 373.409, 373.413, 373.414, 373.416, 373.4592, 376.303, 376.305, 376.3071, 403.0623, 403.0625, 403.087, 403.088, 403.0881, 403.504, 403.704, 403.707, 403.722, 403.853 FS. History-New 1-1-91, Amended 2-4-93, 2-27-94, Formerly 17-160.670, Amended 3-24-96, 4-9-02, 12-3-08, 4-16-18.
(a) Completeness of the Department requested data package(s) and the response of involved parties to any Department requests for additional data;
(b) Integrity of samples as determined by complete and proper sample transmittal documentation, and records that demonstrate adherence to proper preservation, transport or other sample handling protocols, as applicable;
(c) Proper use of sample collection methods;
(d) Proper selection and use of analysis methods;
(e) Sufficient use and routine evaluation of quality control measures to establish the precision, accuracy, sensitivity, selectivity, and potential bias associated with the analytical system and associated results;
(f) Proper instrument calibration and verification procedures;
(g) Documentation of all generated data as provided in Rules 62-160.240 and 62-160.340, F.A.C.;
(h) Ability to reconstruct all field sampling and laboratory procedures through the documentation and records of the laboratory or field sampling organization as provided in Rules 62-160.240 and 62-160.340, F.A.C.;
(i) Ability to trace data in the final report to a specific sampling site, date and time;
(j) Status of the laboratory’s certification through the DOH ELCP as provided in Fl. Admin. Code Chapter 64E-1, for any given analyte or category of analytes; and,
(k) Appropriateness of the collected data as related to the specific data quality objectives of the Department program activity or project for which they were collected including those data being considered for secondary use.
(2) The Department will evaluate data according to the criteria in paragraphs (a) through (k) above, and determine if the data are usable.
(3) In addition to subsection (2) above, the Department shall also evaluate data according to the following:
(a) The outlined in the Department’s document “”Department of Environmental Protection Process for Assessing Data Usability (DEP-EA-001/07),”” dated March 31, 2008, which is incorporated by reference in Fl. Admin. Code R. 62-160.800
(b) The description of data quality objectives and criteria for data usability assessments for the Stream Condition Index (SCI) or a BioRecon determination, as discussed in DEP-SAS-001/11, which is incorporated by reference in Fl. Admin. Code R. 62-160.800(2)(e), and the Lake Vegetation Index (LVI), as discussed in DEP-SAS-002/11, which is incorporated by reference in Fl. Admin. Code R. 62-160.800(2)(f)
(4) If the audited data were originally generated for a specific purpose but are being considered for a secondary use for another purpose (secondary use), and the Department determines from the evaluation process, as described in subsections 62-160.670(2) and 62-160.670(3), F.A.C. above, that the data do not meet the data quality objectives for the secondary use, the Department will recommend that the data not be used by the program that is considering the secondary use. The recommendation not to use secondary data does not impact the usability or validity of the data for the program for which the data were originally intended.
Rulemaking Authority 403.061, 403.0623 FS. Law Implemented 373.026, 373.309, 373.409, 373.413, 373.414, 373.416, 373.4592, 376.303, 376.305, 376.3071, 403.0623, 403.0625, 403.087, 403.088, 403.0881, 403.504, 403.704, 403.707, 403.722, 403.853 FS. History-New 1-1-91, Amended 2-4-93, 2-27-94, Formerly 17-160.670, Amended 3-24-96, 4-9-02, 12-3-08, 4-16-18.