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Certification Update. New and Some Not-So-New Items of Interest steve_arms@doh.state.fl.us 904-791-1502 http://www.doh.state.fl.us/lab/EnvLabCert/WaterCert.htm. Topics. The NELAC Institute (TNI) Proficiency Testing (PT) Rules Certification clarifications. http://www.NELAC-Institute.org.

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Certification Update


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    1. Certification Update New and Some Not-So-NewItems of Interest steve_arms@doh.state.fl.us904-791-1502 http://www.doh.state.fl.us/lab/EnvLabCert/WaterCert.htm

    2. Topics • The NELAC Institute (TNI) • Proficiency Testing (PT) • Rules • Certification clarifications

    3. http://www.NELAC-Institute.org

    4. Current Status of TNI Standards • Field Activities and AB General Requirements and OSA modules are Final Standards • Draft Interim Standards (QS and PT) vote held in July • Comments discussed at The Forum in Cambridge • Committees modify the modules as a result of persuasive comments received, and the membership will have the opportunity to change their votes • Resulting IS will be discussed at the Jan 2008 meeting • Voting follows • Final QS and PT Standards by about May 2008 • 2-yr implementation schedule, if current system followed

    5. TNI Update • New Policies • Conflict-of-Interest • Ethical Conduct • Transition from NELAC almost complete (only AARB remains) • QM template available • Standards w/ISO coming out for sale

    6. TNI Cambridge Forum presentations • Activities of the NELAC Institute • EPA's Drinking Water Certification Program:History, Status and Direction • Who Accredits the Accreditors? • Identifying Deficiencies and Implementing Corrective Actions • Accreditation Body Fee Structures • Comparison Table of Accreditation Body Fees • Advocacy Committee • On-Site Assessment Committee • Laboratory Accreditation System Committee • Mentoring Session • NELAP Board • Technical Assistance Committee

    7. Proficiency Testingtiming • 2 per year (July 1-June 30) per FoPT (matrix-technology-analyte) • No more than 7 months (closing to closing) between studies • No less than 15 days (closing to shipping) between subsequent studies for each FoPT • Every certified DW method once per year • No more than 45 days from shipping to closing (supplemental studies included!)

    8. Proficiency Testingsuccess measures • Pass two of the latest three attempts • Participate in experimental PTs • Choose Florida as recipient of results on or prior to study closing date (exception: FoPTs applied for) • Stay on schedule - missed studies (>7 months between) count as failures

    9. Proficiency Testingrestrictions • Don’t transfer PTs • Don’t exchange information • Handle and analyze PTs like samples • Complete PTs by the time of an assessment for pending FOAs • Use the PT Tables as your guide to selecting required FoPTs

    10. Conditions on PT as DOC • The "4-replicate" procedure outlined in Appendix C.1 to NELAC Chapter 5 is not required by regulation or the method. • The method does not specify a DOC procedure. • Quality Manual documents that using a PT to demonstrate initial capability is an adequate approach. • The PT is in the correct matrix. • Reported results fall within any QC acceptance criteria of the method.

    11. PT News • New tables in effect posted at http://www.nelac-institute.org/ • Some “experimental” analytes moved to “accreditation” status • New Solids table lists two levels for Volatiles and PAHs (NELAP Board is deliberating on this) • ELCP now tracking PT electronically • Use your EPA ID when reporting • Report the certified method • TNI PT Committee considering reverting to one PT per year – Stay tuned!

    12. Certification Application Form • DW methods listed are not necessarily “approved” for compliance testing • Every FOA available is not listed • Consolidate applications, if possible • Pages 1-6 needed (instructions on page 3) • Submit QM or modified pages • Off-site documentation review possible

    13. Rule Updates • MUR • 62-160 • DBPR

    14. Methods Update Rule • SM online and SM 21st Edition are the same • Method flexibility in 136.6 is not applicable to DW • Method modifications must meet requirements of 136.6 • Nitrate CR method now shown as calculation • Discrete analyzers • May have EPA letter or have 136.6 documentation • May reference automated methods

    15. DEP Rule 62-160 Post-Workshop Update • Added a provision to use DW methods NPW where no other method exists. • Removed additional mandatory reporting requirements and added a clarification about the use of data qualifier codes by entities other than the data originator. • Simplified and generalized electronic signatures. • Removed Table 2 (DQIs) and incorporated its contents into DEP-EA-001/07 with substantial revision. Clarified data assessment criteria. • Clarified the intent and procedures for data rejection. • Clarified the definitions for qualifier codes J, V, X.

    16. Disinfection By-ProductsStage 2 DBPR • MRLs defined for TTHM, HAA5, Chlorite, Bromate • Calibration curve must encompass MRL • Check standard run at < 110% of MRL • Must achieve + 50% recovery to report results < 5X MRL • DEP will reject data if the reportedMDL > MRL and a non-detect is reported

    17. Recent Clarifications • Sample preservation • Sample duplicates • SM 21st Edition • Distillation • Method version

    18. Cooling as Sample Preservation • Samples must be collected in “wet” ice • Same-day delivery • Off-temp sample acceptable if chilling process has begun • Still record temperature and document “on-ice”

    19. Microbiology Sample Preservation • Recommend all samples be checked for TRC • Chlorine check as a part of determining proper preservation when sodium thiosulfate is used • DEP rules require the use of thiosulfate "in the presence of residual chlorine" for preservation of Microbiology samples • Measure the TRC and add preservative if necessary • NELAC 5.5.8.3.1(a)(3) exemptions

    20. Duplicates • Microbiology duplicates are to be analyzed on 10% of samples, not plates, or at least one per run (an uninterrupted series of analyses) • Chemistry MS/MSD does not qualify as a sample duplicate when one is required by method

    21. SM 21st Edition News • CBOD • Allylthiourea (ATU) allowed as nitrification inhibitor • Inhibitor not added to water quality check (blank) • Microbiology media in screw-cap tubes may be stored at 25oC for up to 2 weeks

    22. Distillation • EPA Region 4 requires distillation of samples for fluoride and ammonia unless a comparative study has been performed to demonstrate that the distillation is not necessary • Statistically compare values on at least 7 samples • If the comparative data shows no difference, then the variance of not distilling is acceptable • Comparison must be performed on representative effluents • If the waste stream changes and is no longer representative then another study must be performed

    23. Method Version “Most recent” revisited • NELAC 5.5.4.2.1 - Methods published in international, regional or national standards shall preferably be used. The laboratory shall ensure that it uses the latest valid edition of a standard unless it is not appropriate or possible to do so • NELAC 5.5.2.6 - technical personnel … perform the most recent version of the test method (the approved method or standard operating procedure as defined by the laboratory document control system)

    24. Plain Language A perissodactyl ungulate may be propelled toward a body of aqueous fluid, but such ungulates cannot be forcibly induced to imbibe such fluid.

    25. Plain Language You can lead a horse to water, but you can’t make it drink.

    26. Thank You!