Current through Register 1527, August 2, 2024
Section 42.13 - Reporting Requirements(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.Amended by Mass Register Issue 1325, eff. 11/4/2016.