Current through Register 1531, September 27, 2024
(1) No certified or
provisionally certified laboratory shall report analytical results as a
Department-certified laboratory unless:
(a)
The laboratory conducted the analytical measurements at the laboratory's
address as stated in its current certificate;
(b) The laboratory clearly distinguishes in
the report among those analyses for which it is certified, provisionally
certified, or not certified by the Department; and,
(c) For those analyses for which it is
certified or provisionally certified, the laboratory clearly distinguishes in
the report between those analyses that it conducted in accordance with
Department certification standards and those that it did not conduct in
accordance with Department certification standards.
(2) All reports of analytical measurements
conducted by a Department-certified laboratory in accordance with the standards
of
310 CMR 42.00 where such
standards are required or otherwise specified by the laboratory's client must
include the following information:
(a) The
Massachusetts Laboratory Certification identification number of each laboratory
that performed the analytic measurements;
(b) The results of analysis of samples with
the specific analytes measured by each laboratory that performed any of the
analyses identified in the report;
(c) The results of analyses of reagent
blanks, laboratory fortified blanks, laboratory fortified sample matrices, and
duplicates, and surrogate analyte recovery data when requested by the
Department;
(d) The analytical
methods used to detect and quantify the analytes of interest. Sample
preparation procedures, if not included in the referenced analytical
procedures, must also be referenced or described; and
(e) The date of sample extraction, if
applicable to the analytical method performed, and the date of sample
analysis.
(3) With the
exception of reports submitted to the Department in a format approved by the
Department, all reports of finished drinking water analyses must indicate the
maximum contaminant level and/or the maximum residual disinfectant level for
each analyte measured where a maximum contaminant level or maximum residual
disinfectant level has been established by the EPA or by the Department. Where
a maximum contaminant level or maximum residual disinfectant level has not been
established, the laboratory must indicate the drinking water guideline for each
analyte as published by the Department's Office of Research and
Standards.
(4) The actual format of
the data submitted to the Department is left to the discretion of the
laboratory unless otherwise specified. The Department encourages the use of
summary tables that allow the reader to easily review and compare the
data.
(5) A certified laboratory
shall be required to have current knowledge of all Federal and Massachusetts
standards for all categories in which it has been certified or provisionally
certified, and to report analytical results in a timely manner.
(a) Upon obtaining Valid Data, a certified
laboratory shall notify its clients of the results of all samples that exceed
any EPA- or Department-established maximum contaminant level (MCL), maximum
residual disinfectant level or reportable concentration, or that identify the
presence of regulated microbiological organisms in potable water. Notification
must clearly indicate that a regulatory limit has been exceeded. The date,
time, and manner of notification must be documented and kept on file.
(b) A laboratory that accepts potable water
samples for analysis must notify its client public water system of the results
of all samples that exceed a regulatory limit. Data indicating an exceedance of
a regulatory limit must be validated and the validated data reported as soon as
possible, not to exceed 24 hours after the completion of sample analysis. Such
notification must be given within 24 hours of the completion of the analysis of
the sample whether or not the laboratory accepting the sample subcontracted the
analysis to another laboratory.
(c)
Laboratories must identify, in writing, those samples needing special reports
(e.g., MCL exceedance) when the laboratory subcontracts with
another laboratory.
(d)
Laboratories accepting samples to be analyzed for the purpose of determining
regulatory compliance must ensure that analytical data are reported in a timely
manner to meet their clients' reporting requirements. A laboratory that has had
regulatory compliance samples subcontracted to it by another laboratory must
release analytical data to the client laboratory within the timeline arranged
by the laboratories.
(e)
Laboratories must have written standard operating procedures in place which are
designed to ensure that the requirements of 310 CMR 42.13(5)(a) through (d) are
met.
(f) If preliminary data or
data for which data quality objectives were not achieved are reported, they
must be accompanied by a case narrative describing quality control outliers or
any other factors affecting data usability.
(6) A laboratory shall notify the Department
in writing upon any change in ownership, laboratory name, laboratory location,
personnel, equipment, or any factor that could impair the analytic capability
of the laboratory. Personnel changes must be reported within ten calendar days
and shall be limited to loss or replacement of the Laboratory Director,
Laboratory Supervisor, or any other personnel that results in the
unavailability of trained and experienced analysts necessary to perform the
analyses for which the laboratory has been certified. Changes affecting the
availability of properly operating equipment to perform analyses for which the
laboratory is certified, where the equipment has been, or will be, unavailable
for a period of 14 calendar days or more, must be reported in writing to the
Department within 14 calendar days of the onset of the change to the
instrument's operational status.
(7) The present owners of a certified or
provisionally certified laboratory shall notify the Department in writing of a
sale or change in ownership of the laboratory within ten calendar days of the
same.
(8) The owner of a certified
or provisionally certified laboratory seeking to maintain its certification
status while changing the laboratory location shall notify the Department in
writing at least 30 calendar days prior to any such change. The Department may
issue an amended certificate for the new location indicating the laboratory's
certification rating for each matrix, discipline and category if it finds that
the laboratory meets the Department's criteria for certification.
(9) A laboratory that has been certified by
EPA or by its resident state shall notify the Department upon receipt of notice
from EPA or the resident state that its certification has been downgraded,
suspended, or revoked.
(10) A
laboratory shall submit to the Department a copy of the following kinds of
documents:
(a) within 30 calendar days of
receipt by a Department-certified laboratory of a citation, settlement
agreement, judgment, order, enforcement notice or report, or inspection report
that is issued by any local, state, or federal government agency that cites
violations of that laboratory's conditions, equipment, or operations.
(b) a Department-certified laboratory must
supply a copy within 3 0 calendar days of receipt of documents from its
director, supervisor, and owner holding greater than 5% equity. The documents
include a citation of violations or settlement agreement issued by any local,
state, or federal government agency naming the individual and documents
evidencing a civil or criminal conviction of that individual involving
operations of any other environmental laboratory certified or accredited by EPA
or any state. The Department-certified laboratory must ensure that its
director, supervisor, and owner are required to submit a copy to it within 30
calendar days of receipt of such documents by the individual.
(c) a laboratory applicant for certification
shall provide a copy pursuant to 310 CMR 42.13(10)(a) of documents received
within the last five years, and pursuant to 310 CMR 42.13(10)(b) of documents
received by a current owner, director, and/or supervisor within the past five
years.
