Chapter 62-160, F.A.C. – List of Changes to the 2008 Quality Assurance Rule
The following is a summary of the
changes to Chapter 62-160, FAC. Please contact
for further information.
||Clarifies the scope and applicability of the rule for all entities and activities that are a part of the sample
collection and laboratory analysis process.
||Adds a definition for common carrier. Adds a definition for commercial vendors, who are exempted from the scope of
the QA rule, with an exception for organizations that purchase commodities with the intent of providing the
commodities as a service to clients, whose activities do fall under the authority of the rule. Revises the
definition of data quality objectives. Adds a citation to Chapter 64E-1, F.A.C. as a reference for lab certification
requirements. Adds a definition for electronic signature. Revises the definition for Method Detection Limit (MDL).
Clarifies that MDLs shall be determined for each matrix/analytical technology/analyte combination reported
by a lab. Adds a provision to allow calculation of MDLs by any technically justifiable and scientifically sound
method other than those prescribed in this rule, when a specific method is not required by a Department program.
Adds clarifications for certification requirements for the analyses of TCLP extracts derived from matrices defined as
solid or chemical materials. Revises the definitions of National Environmental Laboratory Accreditation Conference
(NELAC)/Program (NELAP). Deletes the definition for data rejection. Adds a definition for secondary-use data.
||Clarifies the types of organizations that must comply with the requirements of DEP-SOP-001/01 (DEP SOPs).
||Adds three SOPs to the list of biological procedures than cannot be modified or for which an alternative procedure
cannot be substituted. Revises language and adds new requirements for providing notice (by DEP) of the approval
or disapproval of requests to use new or alternative procedures and for the recission of previously approved
procedures. Revises and adds language about the right to an administrative hearing under Chapter 120, F.S.
regarding such approvals and disapprovals.
||Clarifies the intent and scope of the documentation and reporting requirements in this rule section for entities
that conduct or support field activities and field measurements. Adds the requirement that specified records
shall contain sufficient information to allow independent reconstruction of all activities related to generating
data submitted to the Department. Clarifies that DEP may request specified field records for a sampling site or
facility at any time.
||Clarifies the definition of sample matrix for lab certification. Revises certification requirements for
flexibility in reporting methods and analytes for compliance with DEP non-potable water regulations where
multiple methods using the same analytical technology are available. Adds a provision, requiring certification, for
reporting drinking water methods for non-potable water analyses when non-potable water methods have not been
published for analytes. Clarifies that DEP allows certification based on the analyte/matrix/analytical
technology combination for non-potable water and on the analyte/matrix/test method combination for all other
matrices. Adds a requirement that a lab must make a written request to the Department for approval (under
certain conditions) to use a method for which it has not completed all of the certification steps. Adds to the list
of tests exempted from lab certification requirements: turbidity (both lab and field methods are now exempt);
bacteria tests for remediation activities (usually applicable to contaminated sites); and, any method in
which the reported result is a calculation using the results of other certified methods.
||Cites Federal Register updates to EPA-approved lists of methods for compliance analyses related to the Clean Water
Act and Safe Drinking Water Act, and provides a 6-month grace period after the effective date of the QA rule
(12/3/08) for laboratories to make any necessary changes to certification status to reflect these updates. Adds the
Lake Vegetation Index calculation to the list of procedures requiring the use of DEP-SOP-002/01 (DEP SOPs)
to be used for certain biocriteria applications.
||Adds the Lake Vegetation Index (DEP SOP LT 7500) to the list of determinative procedures for which an alternative
method cannot be approved. Adds new requirements for providing notice (by DEP) of the approval or disapproval
of requests to use new or alternative analytical methods and for the recission of previously approved methods. Adds
language about the right to an administrative hearing under Chapter 120, F.S. regarding such approvals and
disapprovals. Adds a citation to 40 CFR, Part 136.6 to the list of federal rules governing the approval of
alternative analytical methods for NPDES compliance.
||Clarifies the intent of this rule and revises lab documentation, archival and reporting requirements. Adds
requirement for lab records to contain sufficient information to allow independent reconstruction of all
events linked with data submitted to DEP, and to support the analytical report described in this rule. Adds
requirement for the lab to provide records or copies to DEP when requested. Adds reporting requirements and
exemptions for "in-house" ("captive") labs. Clarifies requirement to report data in specified paper or
electronic formats when required by DEP. Adds citation to NELAC standards for re-issuance (amendment) of lab
reports. Adds language prohibiting alteration of data or deletion of data qualifier codes originally reported by
another party, unless specifically directed to do so by DEP, when data are submitted to DEP in summary,
re-published or reduced form, where the altered data changes the meaning or numerical significance of the
original data. Requires the submittal of original lab report(s) with re-worked data. Adds requirements for
entities other than the data originator who add data qualifier codes to the original data through validation or
review independent of the originator's reporting activities.
||Adds a new section on minimum requirements for electronic signatures accepted as equivalent to written signatures by DEP.
||Revises the calendar for Department issuance of preliminary reports subsequent to audits and the time
allowed for the audited party’s required response. Deletes language about rejecting data based on the audited party’s
lack of response and replaces it with an intent to not recommend use of the affected data to the applicable DEP
program(s). Also clarifies the Department’s obligation to issue a final response to the audited party and any other
substantially affected interests. Revises and adds language about the right to an administrative hearing
under Chapter 120, F.S. regarding the final response.
||Clarifies and adds language describing how the Department will evaluate data quality indicators (DQI) for specific
uses of data designated by Department programs, when conducting audits, data validations or other types of data
review. The list of general criteria and concepts by which data is assessed and validated is expanded. Adds language
to clarify the relationship between data usability evaluations and original vs. secondary uses of data. In
support of the changes to 62-160.670, a document, "DEP Process for Assessing Data Usability", DEP-EA-001/07 is
incorporated by reference to further detail the process for assessing data usability. Deletes language in this
section describing when the Department may reject data, including language about rejection of data based on lab
certification status, and deletes the procedure for issuing a notice of intent to reject the data.
||Revises and adds to the list of data qualifier codes (Table 1): D, I, J, M, V, Z (all revised) and X (added).
||The list of documents incorporated by reference into the QA rule is updated. Two of the references have been
revised as part of the proposed rule changes and comprise the Department’s Standard Operating Procedures for
specific field and laboratory activities (DEP-SOP-001/01 and DEP-SOP-002/01). A document, "DEP Process for
Assessing Data Usability", DEP-EA-001/07, is incorporated by reference to further detail the process for assessing
data usability. Other selected references are added or deleted.
QA Rule 62-160
QA Officer Resources
QAPP for 106 Programs
DEP SOP Training at TREEO Center
Biological Assessment QA
Bureau of Labs
The NELAC Institute (TNI)
TNI Certified Lab List
TNI Standards Page