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Certification Update. New and Some Not-So-New Items of Interest [email protected] 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

New and Some Not-So-NewItems of Interest

[email protected]


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  • The NELAC Institute (TNI)

  • Proficiency Testing (PT)

  • Rules

  • Certification clarifications

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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

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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

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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

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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!)

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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

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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

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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.

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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!

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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

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Rule Updates

  • MUR

  • 62-160

  • DBPR

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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

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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.

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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

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Recent Clarifications

  • Sample preservation

  • Sample duplicates

  • SM 21st Edition

  • Distillation

  • Method version

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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”

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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 exemptions

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  • 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

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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

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  • 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

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Method Version “Most recent” revisited

  • NELAC - 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 - 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)

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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.

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Plain Language

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