62-160.300. Laboratory Certification  


Effective on Monday, April 16, 2018
  • 1(1) Except as provided in subsections 762-160.300(2) 8through (8), F.A.C., all laboratories generating environmental data for submission to the Department or for use in Department-regulated or Department-sponsored activities shall hold certification from the 34Florida Department of Health, Environmental Laboratory Certification Program (43DOH ELCP). Such certification shall be for all matrix/test method/analyte(s) combinations being measured. The matrix of a sample is defined to be the condition under which the laboratory originally receives the sample, and shall be classified according to the Field of Accreditation Matrix groups defined by subsection 9062-160.120(18), 91F.A.C.

    92(a) Certification shall be based on the matrix of the sample. The matrix of a sample is defined to be the condition under which the laboratory originally receives the sample, and shall be classified according to the Field of Accreditation Matrix groups defined by subsection 13762-160.120(18), 138F.A.C.

    139(b) For laboratories reporting data for drinking water compliance, certification shall be for all matrix/text method/analyte(s) combinations being reported.

    158(c) For 160the non-potable water matrix, 164laboratories shall apply for and receive 170DOH ELCP 172certification in at least one method for each analytical technology/analyte combination being measured. 185The Department will accept any of the combinations certified by the DOH ELCP, according to Rule 20164E-1.102, 202F.A.C., dated 1-24-05.

    2051. When a Department contract, order, permit or Title 62 rules requires a specific method to be reported, laboratories shall report only that method. Laboratories may report additional analytes not published in the reported method, 240if the applicable requirements in Rule 24662-160.330, 247F.A.C. are met, 250and the laboratory is certified according to paragraph 25862-160.300(1)(c), 259F.A.C.

    2602. Except as noted in subparagraph 26662-160.300(1)(c)1., 267F.A.C., above, laboratories may report results by any method that is equivalent in technology to the method for which they hold certification, provided they are certified 293according to paragraph 29662-160.300(1)(c), 297F.A.C., 298for the analyte that is reported. When laboratories report a method for which they do not hold certification, the laboratory shall document that all requirements of the reported method are met.

    3293. If a laboratory is required to provide data for an analyte for which, 343according to subsection 34662-160.320(1), 347F.A.C., 348no method is published for the non-potable water matrix, 357or the published method for the non-potable water matrix does not meet required data quality objectives established by the Department for a project, 380but a method is published for the drinking water matrix, 390and the Department has recognized that the published drinking water method meets the data quality objectives for the Department project for which the method will be used according to subsection 42062-160.320(1), 421F.A.C., the laboratory is not required to obtain certification for the analytical technology/analyte combination in the non-potable water matrix440. However, the laboratory must be 446certified in the drinking water matrix for the reported test method/analyte combination.

    458(d) For all other matrices, laboratories shall apply for and receive certification for all matrix/test method/analyte combinations that are reported to the Department.

    481(2) To the extent possible, a laboratory must be certified as specified in subsection 49562-160.300(1), 496F.A.C., before reporting results for a given matrix/analytical technology or test method/analyte combination. However, if a laboratory makes a written request to the Department to use a method that is not certified, the Department will allow a laboratory to begin using a method before the certification process is complete if the 547following requirements are met551.

    552(a) The laboratory must have met all the requirements for certification except for the on-site visit by DOH ELCP inspectors. The laboratory must be prepared to provide to the Department copies of the relevant application, applicable performance test sample results and the initial demonstration of capability.

    598(b) The precision, accuracy and method detection limits generated by the laboratory must meet or exceed the project specific data quality objectives.

    620(c) The laboratory shall notify the Department of the status of its certification application within 5 business days of receiving notification by DOH ELCP of the certification 647granted for the specific matrix/analytical technology or test method/analyte combination requested658.

    659(3) Laboratory certification by the DOH ELCP is not required for the following test procedures 674identified in subsections 67762-550.550(1) 678and (2), F.A.C., 681when conducted 683by an operator licensed under Chapter 62-602, F.A.C., or by persons under the direct supervision of a licensed operator, 702for the purposes of drinking water compliance:

    709(a) Alkalinity;

    711(b) Bromide;

    713(c) Calcium;

    715(d) Chlorite (only at entrances to distribution systems);

    723(e) Specific conductance;

    726(f) Disinfectant residual (includes residual chlorine);

    732(g) Orthophosphate;

    734(h) pH;

    736(i) Silica;

    738(j) Specific ultraviolet absorbance;

    742(k) Temperature;

    744(l) Total organic carbon;

    748(m) Turbidity, or

    751(n) Any analytes in addition to those listed in paragraphs 76162-160.300(3)(a) 762through 76362-160.300(3)(m), 764F.A.C., above that are exempted from laboratory certification according to subsections 77562-550.550(1) 776and 77762-550.550(2), 778F.A.C., for the specific compliance applications described therein.

    786(o) The analytes exempted in paragraphs 79262-160.300(3)(a) 793through 79462-160.300(3)(n), 795F.A.C., above shall be analyzed according to all applicable requirements for analyses according to subsections 81062-550.550(1) 811and 81262-550.550(2), 813F.A.C., for the specific compliance applications described therein.

    821(p) In cases where the Department has a specific field testing method standard operating procedure (e.g., FT 1100 for pH, 841in DEP-SOP-001/01, which is incorporated by reference in subparagraph 85062-160.800(1)(a)19., 851F.A.C.852), the laboratory 855or authorized person, as described in Rule 86262-550.550, 863F.A.C., 864shall follow the Department’s procedures. For all other analytes, a laboratory 875or authorized person, as described in Rule 88262-550.550, 883F.A.C., 884shall only use test methods that are acceptable for drinking water compliance, 896as specified in Rule 90062-550.550, 901F.A.C. and shall follow all requirements for calibration verification according to DEP SOP FT 1000 in DEP-SOP-001/01, which is incorporated by reference in subparagraph 92562-160.800(1)(a)18., 926F.A.C.

    927(4) 928Certification 929by the DOH ELCP 933is not required 936when conducting the test procedures 941for the analytes listed in paragraphs 94762-160.300(4)(a) 948through (h), F.A.C., because the Department’s standard operating procedures (SOPs) are more stringent than the corresponding laboratory test methods certified by DOH ELCP. When conducting these test procedures, laboratories shall follow the applicable SOPs in DEP-SOP-001/01 (January 2017), which are incorporated by reference in paragraph 99362-160.800(1)(a), 994F.A.C.

    995(a) pH;

    997(b) Dissolved oxygen;

    1000(c) Specific conductance;

    1003(d) Temperature;

    1005(e) Total residual chlorine (including free available chlorine);

    1013(f) Salinity;

    1015(g) Turbidity; and,

    1018(h) Any other test with a specified holding time of fifteen minutes or less when performed 1034as a field procedure.

    1038(5) Certification is not required for 1044the following tests or analyses1049:

    1050(a) Any analyses related solely to internal process control, 1059unless the test data are reported to the Department to meet compliance monitoring requirements for a Department-issued permit;

    1077(b) 1078Laboratory tests conducted for research projects, 1084as described in Rule 108862-160.600, 1089F.A.C., or

    1091(c) 1092Methods used by statutorily created volunteer monitoring organizations, when the Department has reviewed and concluded that the organization’s Standard Operating Procedures provide sufficient quality assurance requirements for Department purposes.

    1121(6) Certification 1123by the DOH ELCP 1127is not required for methods and procedures required to perform the Specific Oxygen Uptake Rate (SOUR) test, when performed by 1147an operator certified in accordance with Chapter 62-602, F.A.C., or persons u1159nder the direction of a certified operator, as authorized by Chapter 62-640, F.A.C.

    1172(7) Certification is not required for any test in which the reported result is a calculation from the results of other tests for which the laboratory holds certification by the DOH ELCP.

    1204(8) Certification is not required for those matrix/method/analyte combinations (such as taxonomic identification) that are not included in the DOH ELCP scope of accreditation.

    1228(9) If certification is not required (see subsections 123662-160.300(3) 1237through (8), F.A.C.), laboratory organizations shall follow the relevant Department-approved methods as provided in Rule 125262-160.320, 1253F.A.C., 1254and shall meet all other requirements for laboratories as provided in this chapter1267.

    1268Rulemaking Authority 1270403.061, 1271403.0623, 1272403.0625, 1273403.863 FS. 1275Law Implemented 1277373.026, 1278373.309, 1279373.409, 1280373.413, 1281373.414, 1282373.416, 1283373.4592, 1284376.303, 1285376.305, 1286376.3071, 1287403.0623, 1288403.0625, 1289403.087, 1290403.088, 1291403.0881, 1292403.504, 1293403.704, 1294403.707, 1295403.722, 1296403.803, 1297403.853 FS. 1299History–New 1-1-91, Amended 2-4-93, 2-27-94, Formerly 17-160.300, Amended 3-24-96, 4-9-02, 6-8-04, 12-3-08, 7-30-14, 4-16-18.

     

Rulemaking Events:

Historical Versions(3)

Select effective date to view different version.

Related Lawyers (1)