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The following checklists are available to the laboratory to assist in completing the application package.
Field Measurements (e.g. pH, Dissolved Oxygen (DO), Chlorine, etc.)
- Initial start-up data which includes completed bench sheets, calibration records, and applicable quality control records for each parameter the laboratory is seeking certification to perform. This is to include analysis and calibration records for the Proficiency Testing (PT) samples.
Procedures for Chain-of-Custody, SOP Development, and Common Field Parameter Measurements
Inorganic
- Initial or multilevel calibration (ICAL) and calibration verification records documenting that method acceptance criteria have been met for each parameter related to the PT sample, method detection limit (MDL) study, and LLOQ study (LLOQ required for SW-846 methods only).
- Linear Range Studies and all supporting documentation (if applicable).
- Compiled initial demonstration of capability (IDOC) data results for each method and analyte including all information on the example form .
- Compiled MDL study performed within the last 12 months by parameter and method including all information on the example form . MDLs are not required for titrimetric analyses.
- Compiled LLOQ Study (SW-846 Methods only) for each instrument used to report data for each parameter/method.
- Sample analysis records pertaining to the PT sample, MDL study, and LLOQ study results submitted for the application to include sample preparation records (digestion, distillation, etc.), standard preparation records traceable to the certificates of analysis, quality control data, and all data system reports (where applicable) for the completed analyses demonstrating traceability.
- If a PT sample, MDL study, and LLOQ study are not required for the parameter, submit the most recent initial or multilevel calibration (ICAL) and calibration verification (performed within the last 12 months).
Organic
- Multilevel calibration (ICAL) and calibration verification records documenting that method acceptance criteria have been met for each analyte related to the PT sample study. Where applicable, the data must be submitted for both the primary and confirmatory techniques.
- Most recent multilevel ICAL and calibration verification for each analyte, parameter, analytical method, and sample preparation method for an LLOQ verification, MDL study, or recent sample analysis batch (performed within the last 12 months). Also, include extraction records, standard preparation records traceable to the certificates of analysis, quality control data, all chromatograms and data system reports for the completed analyses. The data must include all before and after manual integrations. Where applicable, the data must be submitted for both the primary and confirmatory techniques.
- Compiled initial demonstration of capability (IDOC) data results for each method and analyte including all information on the example form . Where applicable, the IDOC data must be submitted for both the primary and confirmatory techniques.
- Compiled MDL study performed within the last 12 months by analyte and method including all information on the example form along with the MDL sample chromatograms and data system reports demonstrating traceability. Where applicable, the MDLs must be submitted for both the primary and confirmatory techniques.
- Compiled LLOQ Study (SW-846 Methods only) for each instrument used to report data for each parameter/method.
Certification Requirements For Organic Analyses (2017)
Trace Metals
- Multilevel calibration (ICAL) and calibration verification records documenting that method acceptance criteria have been met for each parameter related to the PT sample. Also, include digestion records, standard preparation records traceable to the certificates of analysis, quality control data, all data system reports for the completed analyses demonstrating traceability. Linear Range Studies and all supporting documentation.
- Compiled initial demonstration of capability (IDOC) data results for each method and analyte including all information on the example form .
- Compiled MDL study performed within the last 12 months by parameter, analytical method, and sample preparation method including all information on the example form .
- Compiled LLOQ Study (SW-846 Methods Only) for each instrument used to report data for each parameter/method. If a PT sample is not required for the parameter, submit the most recent multilevel calibration and calibration verification (performed within the last 12 months) for the LLOQ or MDL study.
Trace Metals Guidance Document (2/2017)
Microbiological
- Media quality control records, media preparation records (if applicable), sterility check records for equipment and media, AM/PM temperature records (incubators, water baths, etc.), and Quanti-Tray® sealer check records (if applicable) related to the equipment and media used for the PT sample.
- Sample analysis records pertaining to PT sample results submitted for the application to include verification records if applying for membrane filtration methods.
- If not currently certified by this Office for microbiological analyses, then autoclave records and spore ampule efficiency check records must be submitted.
Guidance Documents
Cryptosporidium
- Quality control records to include the following: IPR, OPR, MB, MS, and two acceptable PT study analysis records. The two PT studies must have been performed within the past 18 months.
- The most recent three months of analyst verifications for each pertinent Cryptosporidium method.
- Two complete sample data packages from the past 12 months. This would include the chain-of-custody records, analysis records, and quality control records for those packages.
- Completed EPA checklists A, B, and C (Supplement 2 to the Fifth Edition of the Manual for the Certification of Laboratories Analyzing Drinking Water) from the primary certifying authority.
Whole Effluent Toxicity
- Completed culture and test records (reference toxicant and/or baseline data, YCT, and algae preparation records), bench sheets, and instrument calibration records (pH, DO, residual chlorine, alkalinity and specific conductance) must be submitted. Note that the laboratory must obtain and maintain concurrent certification for the following parameters under the Clean Water Act: pH, DO, alkalinity, specific conductance, total hardness, temperature, and residual chlorine.
Biosolids
- SOPs for fecal coliform analysis for biosolid (i.e. sludge) samples and % total solids (SM 2540G). These procedures must include sample preparation, analysis, and calculations as documented in Appendix F of EPA/625/R-92/013 (Revision 2003).
- Completed sample preparation records, biosolid analysis records (fecal coliform and % total solids), and quality control checks associated with fecal coliform analysis.
- Media quality control records, media preparation records (if applicable), sterility check records for equipment and media, and AM/PM temperature records (incubators, water baths, etc.).
- If not currently certified by this Office for microbiological analyses, then autoclave records and spore ampule efficiency check records must be submitted.
Biosolids Pathogen Certification (2/2017)
Taxonomy
- SOP and/or QA plan for taxonomic identifications must address the procedures for sample collection, preservation, sorting, identification, documentation, reference and voucher collection maintenance, and quality control (e.g. sorting and efficiency checks). Collection equipment used and their purpose must be listed.
- List of reference materials and taxonomic keys used to identify organisms in the taxonomic group for which you are seeking certification.
- Chain-of-custody forms used for sample collection.