Fla. Admin. Code Ann. R. 62-160.340 - Record Keeping and Reporting Requirements for Laboratory Procedures

(1) Laboratory record keeping requirements shall follow those specified by the DOH ELCP in Rule 64E-1.005, F.A.C., dated 1-24-05 and this chapter.

(a) The laboratory records shall contain sufficient information to allow independent reconstruction of all activities related to generating data that are submitted to the Department.

(b) In addition, the laboratory shall ensure that its records include all information necessary to support the analytical report (subsection 62-160.340(3), F.A.C.).

(c) Records shall be retained for a minimum of five years after the date of generation or completion of the records unless otherwise specified in a Department contract, order, permit or Title 62 rules.

(d) Electronic records shall be acceptable as documentation and shall be considered as equivalent in status and function to paper records or documents, unless otherwise specified in a Department contract, order, permit or Title 62 rules.

1. All documentation requirements in this chapter shall apply equally to paper and electronic records.

2. Electronic copies intended to replace original records shall contain the same information as the original records, regardless of whether the electronic copies are designated as master or duplicate records.

(2) When requested by the Department, the laboratory shall provide the Department any records or copies of the records needed to reconstruct analyses, such as:

(a) Laboratory and project information including:

1. Signed and dated final report (laboratory analytical report) as specified in subsection (3) below;

2. Project information such as client name, site name, client project number, or client project name;

3. When applicable, the quality assurance project plan associated with the project;

4. Client or field identification number for each sample;

5. Date and time of sample collection;

6. Sample matrix (e.g., groundwater, effluent, waste, soil);

7. Sample type (e.g., environmental sample, field blank, matrix spike); and,

8. Identification of all laboratories providing analytical results in the report and the appropriate laboratory certification numbers from the DOH ELCP (if applicable) for each laboratory.

(b) Sample receipt, preparation and analysis information including:

1. Laboratory identification number for each sample fraction;

2. Sample receipt conditions such as proper and intact custody seals;

3. Positive verification of chemical and/or physical sample preservation during sample receipt and/or before sample analysis. The information shall include the preservation acceptance criteria, an indication of acceptability, and the value(s) if the criteria are not met;

4. Sample preparation information, if applicable, including method, date of sample preparation and time of sample preparation if the holding time specified in Rule 62-160.400, F.A.C., is less than or equal to 72 hours;

5. Sample analysis information including analytical method, date of sample analysis, and time of sample analysis if the holding time specified in Rule 62-160.400, F.A.C., is less than or equal to 72 hours; and,

6. Analysis records of original data. Original data is information generated at the time of or as the result of performing laboratory procedures or tests; e.g., "raw" data automatically reported or logged from analytical instrumentation, such as strip chart recordings or chromatograms; handwritten laboratory notes, laboratory notebooks or drawings; completed laboratory forms or bench sheets; and photographs.

(c) Sample result information including:

1. Analyte or organism name as applicable;

2. Test result with all applicable data qualifiers, as specified in Table 1: Data Qualifier Codes;

3. Test result units;

4. Other sample characteristics such as percent moisture or fraction (i.e., total or dissolved); and,

5. Textual comments, if applicable, that specify any deviations (such as failed quality control), additions to, or exclusions from, the analytical method, and any non-standard conditions (such as sample matrix or environmental conditions) that have affected the quality of results.

(d) Laboratory quality control information, such as:

1. Identification that unambiguously links groups of samples to a specified set of activities such as preparation, analysis, shipping, reporting, or quality control;

2. Laboratory blank results (results for any laboratory blank analysis as required by the DOH ELCP certification or the analytical method); and,

3. Information pertaining to replicate sample analysis including an unambiguous designation of the replicate sample (e.g., sample duplicate, sample matrix spike duplicate, or laboratory control spike duplicate); result of laboratory replicate analysis; replicate precision expressed in terms required by the reported method or as Relative Percent Difference or Percent Relative Standard Deviation (defined in DEP-QA-001/01 (January 2017), which is incorporated by reference in paragraph 62-160.800(1)(a), F.A.C.); and acceptance limits for controlling replicate precision (in-house control limits used by the data generator when control limits are not specified by the reported method or data quality objectives identified by the Department).

(e) Instrument Calibration/Verification including:

1. Number of standards;

2. Acceptability requirements for initial calibration, and initial and continuing calibration verifications; and,

3. Origin, and preparation (if applicable) for all standards used for calibration.

(f) For chemical testing:

1. When applicable, indication that a sample was filtered in the laboratory;

2. For each analyte, records to support:

a. When applicable, determination of method detection limit(s) and practical quantitation limit(s) including the method by which each are determined; the raw and processed data supporting the determination(s); and effective dates; and,

b. Dilution factor (if applicable).

3. Matrix or laboratory control spike information including concentration level (level of analyte added to a spiked sample), matrix or laboratory control spike recovery (results for matrix spike/duplicate sample analysis including those required by methods) and matrix or laboratory control spike recovery limits (in-house recovery limits used by the data generator when control limits are not specified by the reported method or data quality objectives identified by the Department); and,

4. When performed, surrogate spike information including concentration level (level of analyte added to the sample), surrogate spike recovery, and surrogate recovery limits (in-house recovery limits used by the data generator when control limits are not specified by the reported method or data quality objectives identified by the Department).

(g) For microbiological testing:

1. Results of all applicable reagent or dilution water quality or suitability test associated with samples;

2. Results of all media quality control tests; and,

3. Sample ID of sample used to verify positive results and results of such verifications.

(h) For toxicity (bioassay) testing:

1. Test type (acute or chronic);

2. Test organism(s) used;

3. Age(s) of test organism(s);

4. Test result(s);

5. Statistical method used to generate the result(s);

6. Control data (e.g., mortality/weight/reproduction) as appropriate to test type;

7. Test end points and confidence intervals;

8. Standard reference toxicant data associated with batch of test organisms; and,

9. Physical and chemical measures that are associated with the test (e.g., pH, temperature, dissolved oxygen).

(i) For benthic invertebrate taxonomic identification:

1. Sorting efficiency, as percent (%);

2. Number and identity of taxa in sample;

3. Percent agreement between or among identifications performed by two or more independent taxonomists associated with the period when results were generated;

4. Indication of which organisms were verified against standard reference collection; and,

5. Indication of whether the organism range includes Florida.

(j) For algal taxonomic identification:

1. Percent agreement between or among identifications performed by two or more independent taxonomists associated with the period when results were generated;

2. Number and identity of taxa in the sample;

3. Microscope magnification;

4. Dilution factor;

5. Surface area sampled (periphyton) or volume sampled (phytoplankton);

6. Number of fields counted; and,

7. Counting chamber dimensions.

(k) Field quality control results including trip blanks, field blanks, equipment blanks, and field replicates as required by individual DEP SOPs in DEP-SOP-001/01, which is incorporated by reference in paragraph 62-160.800(1)(c), F.A.C., or the applicable contract, order, permit, or title 62 rules;

(l) Any additional elements specified by the Department in contracts, orders, permits, Title 62 rules, or Department-approved planning documents such as quality assurance plans, sampling and analysis plans, and monitoring plans;

(m) All documentation for alternative and modified methods, as required in Rule 62-160.330, F.A.C.; and,

(n) Any additional records required in individual DEP SOPs in DEP-SOP-002/01, which is incorporated by reference in paragraph 62-160.800(1)(b), F.A.C., including DEP SOP LD 1000 and all parts and subparts of LD 1000 therein; and, any additional records required in individual DEP SOPs in DEP-SOP-003/11, incorporated by reference in paragraph 62-160.800(1)(c), F.A.C., including all DEP SOP parts and subparts therein, as applicable to the documentation of bioassessment activities.

(3) Except as noted in subsection (4) below, a laboratory shall generate an analytical report that meets the requirements of the DOH ELCP, as specified in Rule 64E-1.005, F.A.C., dated 1-24-05, and the 2016 TNI Standard, which is incorporated by reference in paragraph 62-160.800(3)(b), F.A.C. The report shall contain all applicable reporting elements specified in and shall otherwise comply with requirements specified in Sections 5.10 through 5.10.11 of Module 2 of the 2016 TNI Standard (Quality Systems General Requirements), and shall use the applicable qualifiers as defined in Table 1: Data Qualifier Codes (Rule 62-160.700, F.A.C.). In addition to the stated requirements, laboratories shall ensure that the following requirements are met or reported:

(a) All results that are less than the laboratory's practical quantitation limit shall be reported using the applicable data qualifiers.

(b) Except for tests in which a method detection limit is not required, non-detected analytes shall be indicated by the method detection limit value, followed by the code "U."

(c) For tests that do not require a method detection limit study (e.g., biochemical oxygen demand, chlorophyll or microbiological tests), values below the reporting limit attributed to the test shall be reported as the reporting limit value followed by the code "U."

(d) When the holding time for a preparation step is specified, the date of sample preparation shall be reported. The time shall also be reported if the holding time for sample preparation is equal to or less than 72 hours.

(e) Any additional information specified by the Department in contracts, orders, permits or Title 62 rules shall be reported.

(4) Laboratories that are operated by a facility and whose sole function is to provide data to the facility management for compliance purposes (i.e., in-house or captive laboratories as described in section 5.10.10 of Module 2 of the 2016 TNI Standard (Quality Systems General Requirements), which is incorporated by reference in paragraph 62-160.800(3)(b), F.A.C., shall meet the requirements specified in that standard.

(5) If required by the Department in an applicable contract, order, permit or Title 62 rules, or requested by a Department program, laboratory data issued to a client(s) for Department-related work or directly to the Department shall be provided in the Department-specified paper format or in an electronic format meeting Department requirements for importing into Department databases or for other electronic submission requirements.

(6) Once issued, a laboratory report is considered final and shall not be amended. Amendments or corrections to a final laboratory report shall be made in accordance with the requirements of section 5.10.9 of Module 2 of the 2016 TNI Standard (Quality Systems General Requirements), which is incorporated by reference in paragraph 62-160.800(3)(b), F.A.C.

(7) When data are provided to the Department in a document that is a summary, a re-published format or in a reduced form (e.g., report, table, report form), the document shall not change the original data, or delete any data qualifiers reported by the originating laboratory unless specified by Department contract, order, permit, or Title 62 rules. Copies of the original laboratory report(s) shall be submitted with all such reports unless directed to do otherwise by the Department.

(8) When data qualifiers are added through a validation or review process that is independent of the laboratory reporting process, the reason for the addition, the date of the addition, and the person adding the qualifier(s) shall be included. These qualifiers shall be included in any documents that are summaries or re-published formats, as described in subsection (7) above.

Notes

Fla. Admin. Code Ann. R. 62-160.340

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.

New 4-9-02, Amended 6-8-04, 12-3-08, Amended by Florida Register Volume 40, Number 136, July 15, 2014 effective 7/30/2014, Amended by Florida Register Volume 44, Number 065, April 3, 2018 effective 4/16/2018.

New 4-9-02, Amended 6-8-04, 12-3-08, 7-30-14, 4-16-18.