TNI PT Program Update WEAT Laboratory Conference June 2012 Shawn Kassner 2011 Waters Corporation 1
Topics Implementation of 2009 TNI PT Standard 2009 TNI PT Standard changes Summary Changes to Field of Proficiency Testing Tables Whole effluent toxicity TIA MUR Rule Standard Methods References 2011 Waters Corporation 2
Implementation TNI and Accreditation Council established July 1, 2011 as the initial effective date for the 2009 Standard Not all states have changed their laws and/or rules changed to allow for the implementation to occur The accreditation council has established a 2-yearish plus period for implement of the 2009 TNI standard All NELAP states are recognizing accreditations granted by other NELAP ABs, whether they are accrediting to the 2003 or 2009 standards 2011 Waters Corporation 3
TNI State Implementation Status Texas following 2009 standard Other TNI states Illinois following 2003 standard, waiting for next WDS to implement Pennsylvania following 2009 for WP and SCM o Drinking water (WS) follow 2003 Virginia following 2003 o Rulemaking starting Jan 2012 for 2009 standard Oregon following 2009 standard Florida following 2009 standard Minnesota implementing 2009 standard in Jan 2012 New York implementing 2009 standard 2011 Waters Corporation 4
TNI State Implementation Status California rulemaking underway for 2009 standard LA (DEQ & DHH) preparing documents for public comment Kansas following 2003 standard, limited resources to implement at this point will reconsider in 2012 New Hampshire - rulemaking starting in Jan 2013 Utah following 2009 standard New Jersey rule making under way 2011 Waters Corporation 5
Non-TNI States Non-TNI states Oklahoma: 2003 Evaluation rules South Carolina: 2003 Evaluation rules West Virginia: 2003 Evaluation rules Nevada: 2003 Evaluation rules All other non-tni states CALL EM 2011 Waters Corporation 6
2009 TNI PT Standard Changes 2011 Waters Corporation 7
PT Standard Changes Old structure 2003 Standard, Chapter 2: Proficiency Testing includes requirements for: o Laboratories o PT Providers o Laboratory Accrediting Bodies o PT Provider Accreditors o PT Board (PT Executive Committee) 2011 Waters Corporation 8
PT Standard Changes New structure 2009 Standard is separated by Volumes and Modules o Volume 1, Module 1: Laboratories o Volume 2, Module 2: Laboratory Accreditation Bodies o Volume 3: PT Providers o Volume 4: PT Provider Accreditors Attempted to remove requirements for PT Executive Committee and other such groups 2011 Waters Corporation 9
PT Standard Changes Assigned value of unspiked analytes 2003: assigned value of unspiked analytes set to zero (B.1.2) 2009: assigned value of unspiked analytes set to <PTRL (V3, 6.3.5) o PTRL = Proficiency Testing Reporting Limit listed in the FoPTs PT providers must confirm that unspiked analytes are not present in the PT sample at or above one-half the PTRL (V3, 7.1.11) The absence of unspiked analytes must be reconfirmed during stability analysis Reasoning Zero is not scientifically valid Avoids labs being scored not acceptable for false positives if they report a very low value Give PT providers an objective target for confirming absence of unspiked analytes 2011 Waters Corporation 10
PT Standard Changes Evaluation of < reported data 2003 o <X is acceptable if assigned value = 0 o <X is acceptable if lower acceptance limit = 0 and X is < upper acceptance limit (B.1.2) 2009 o <X is acceptable if assigned value = <PTRL (or = 0) o <X is acceptable if X lower acceptance limit (V3, 10.3.1 & 10.3.2) 2011 Waters Corporation 11
Evaluation of <X Reported Values <X is acceptable if assigned value = <PTRL (or = 0) Any <X reported value is acceptable Reported value: <X Assigned value: <PTRL 0 PTRL 2011 Waters Corporation 12
Evaluation of <X Reported Values <X is acceptable if X lower acceptance limit Not Acceptable if X < LAL Acceptable if X > LAL Reported value: <X Acceptance Limits: LAL to UAL 0 LAL UAL 2011 Waters Corporation 13
Evaluation of <X Reported Values 2003 NELAC Standards 2003: <X is acceptable if lower acceptance limit = 0 and X is < upper acceptance limit Not Acceptable because LAL is not equal to zero Reported value: <X Acceptance Limits: LAL to UAL 0 LAL UAL Acceptable if X < UAL Not Acceptable if X > UAL Reported value: <X Acceptance Limits: 0 to UAL LAL = 0 2011 Waters Corporation 14 UAL
Reporting of <X Reported Values What is X? Multi-point calibration: X = [low calibration standard] o Same as used for routine environmental analysis Single-point calibration: X = limit of quantitation (LOQ) o Same as used for routine environmental analysis Volume 1, Module 1, 5.2.1 a and b 2011 Waters Corporation 15
Evaluation of <X Reported Values Reasoning Some NELAC laboratories have permit limits and, thus, calibration ranges and LOQs that are higher than the TNI PT concentration ranges These labs are required to participate in PT, but often times not detect the analytes of interest The options were to develop special calibrations for PTs, which goes against the spirit of treat PTs like real samples, or to fail the sample if they report less-than (not detected) values Other TNI options were to allow these labs to be excluded from PT (this is unfair to other NELAC labs) or develop a class of higher level PT samples (this may happen in the future) The solution in the 2009 standard seemed to be the most realistic (like labs normally report data) and most workable at the time 2011 Waters Corporation 16
PT Scheduling Ongoing studies 2003 o For continuing accreditation, completion dates of successive proficiency rounds for a given field of proficiency testing shall be approximately six months apart. (2.7.2) o Most states interpreted as 5-7 months 2009 o The analysis dates of successive PT samples for the same accreditation FoPT shall be at least five (5) months apart and no longer than seven (7) months apart... (4.2.1 a) o Be careful to watch actual analysis dates, not just study open or close dates 2011 Waters Corporation 17
PT Scheduling Supplemental studies Used for expanding scope or corrective actions 2003 o Analysis dates of supplemental PT studies must be at least 15 calendar days apart from the closing date of one study to the shipment date of another study for the same field of proficiency testing. (2.7.3) o This could be monitored by the PT providers on behalf of the lab 2009 o The laboratory shall ensure that there are at least fifteen calendar days between the analysis dates of successive PT samples for the same accreditation FoPT. (4.1.3 and 6.1.b) 2011 Waters Corporation 18
PT Scheduling Supplemental studies 2003 2.7.3.1 All other aspects of Supplemental PT studies for Demonstrating Corrective Action including scoring and distribution of final reports must meet all other requirements of the NELAC PT Program. 2009 o 8.4.4 The closing date of a supplemental PT study shall be the date that the participant(s) has reported study data for the required analytes. o 8.4.5 The closing date of supplemental PT studies shall be no more than forty-five (45) days after the opening date of the study. 2011 Waters Corporation 19
New Content for PT Final Reports Newly required information for final reports Providers must now include the study mean and study standard deviation for all analytes in the final report A failure rate report must be made available upon request to participating laboratories and accreditation bodies Analysis dates, as reported by the laboratories, must be included on the report The TNI analyte code for each analyte must be included in the final report 2011 Waters Corporation 20
~ One Year What Happened!?! Laboratories have been successfully reporting < values States are getting reports based on the standard they are following either both 2003 and 2009 evaluations Laboratories getting in some cases both sets of reports Many of the bugs have been worked out in the reporting for both the laboratory and the accrediting agencies Questions still occur, but related to specific laboratory reporting issues 2011 Waters Corporation 21
Summary FoPT Table Changes 2011 Waters Corporation 22
Water Pollution FoPTs New WP FoPT table implemented on October 3, 2011 Two new analytes naphthalene, 1,2,4-Trichlorobenzene Some former experimental analytes moved to accreditation table o 6 Inorganic analytes o 6 organic analytes and LL PAHs Several analyte name, concentration range, acceptance limit and footnote changes o 8 concentration ranges changes, many inorganic analytes o Additional guidance for PT design criteria added 2011 Waters Corporation 23
Water Supply FoPTs New WS FoPT table has been approved Implemented January 2012 One new analyte Naphthalene in Unregulated VOA s Some former experimental analytes moved to accreditation table o Hexavalent Chromium, Corrosivity, DOC, Perchlorate, Silica as SO2, MBAS, UV 254 Several analyte name, concentration range, acceptance limit and footnote changes o Many regression equations replaced with fixed limits throughout the table o Pesticides, Unregulated VOA s, Herbicides, Carbamates have updated concentration ranges. 2011 Waters Corporation 24
Solid and Chemical Materials FoPTs New SCM FoPT table has been approved Implemented January 2012 One new analyte Pentachlorophenol added to Acids Analytes removed TOC and Phosphorus as P Some former experimental analytes moved to accreditation table o Minerals, Nutrients standards & Boron add for Inorganics o 7 analytes added to low & medium level VOA s o 4 analytes added to BNA s o 2 analytes to Herbicides Several analyte name, concentration range, acceptance limit and footnote changes 2011 Waters Corporation 25
More Information 2009 NELAP Standards http://www.nelac-institute.org/fopt.php Fields of Proficiency Testing Tables Published on TNI website on their effective date o http://www.nelac-institute.org/fopt.php Final copies of the tables are posted to the TNI web site You can sign up to receive emails from TNI when this page is updated!!! 2011 Waters Corporation 26
What s coming next.. Working Draft Standard being developed to address controversies over the 2009 standard and new modules Analysis dates vs closing dates being discussed o Issues for the states o Issues for the labs < X Evaluations when the assigned value is greater than zero o TNI states unable to implement to due regulatory issues o Non-TNI states plainly disagree with the practice o Does not solve the issue of inappropriate PT s for the effected labs Microbiology/Radiochemistry/WET/Asbestos changes to the standard being considered to address the specific needs of these types of analyses 2011 Waters Corporation 27
What s happening now? General consensus of the participants at the Laboratory PT Committee (LPTC) Sarasota and Seattle Meetings is to change the working draft standard back to the 2003 PTRL PT reporting rules. Finished Volume 1 and Volume 2 edits Working to finish Volume 3 edits Accrediting Council chair now an associate member of the LPTC, along with two other members Fix previously identified issues Change language to be more concise and remove unnecessary confusing examples WET Tentative Interim Amendment (TIA) addressing WET multiple study requirements 2011 Waters Corporation 28
WET TIA What is a TIA? Tentative Interim Amendment designed to fix emergency issues that can not wait to be addressed by the next version of the standard Used sparingly by TNI WET TIA current status NELAP Accreditation Council (AC) vetoed the WET TIA States have incorporated the TNI 2009 Standards by reference into their regulations The AC is requesting further background information prior to accepting the and implementing the WET TIA All parties are committed to resolving the issues ASAP 2011 Waters Corporation 29
WET TIA Proposed Language Proposed Language Whole Effluent Toxicity testing laboratories shall analyze at least one (1) TNI-compliant PT sample per calendar year for each accredited FoPT for which the laboratory holds accreditation with the primary AB. The laboratory shall perform corrective action when a PT study has been failed. Corrective action shall include: a. A written corrective action report b. A copy of the raw data used for the study c. A copy of the current Standard Reference Toxicant (SRT) control chart relevant to the PT study d. Other documentation the laboratory deems necessary to support the conclusions of the report 2011 Waters Corporation 30
WET TIA Proposed Language For Whole Effluent Toxicity Testing fields of proficiency testing, the study closing date for non DMR-QA Studies shall be no more than ninety (90) calendar days after the opening date of the study. For DMR-QA Studies, the laboratory must meet the time frames as stated in the Announcement letter. A non-dmr-qa study is being defined as a WP study. 2011 Waters Corporation 31
Method Update Rule (MUR) Latest Method Update Rule signed and final in April 2012 References for all Standard Methods changing away from different editions to the year the method was approved TNI has completed updating the method code list in incorporate the new EPA references Rumor has it EPA drinking water will be also be adopting this same reference to Standard Methods in the future Multi-year process to complete the CFR changes required 2011 Waters Corporation 32
Thank You! Shawn Kassner skassner@eraqc.com 2011 Waters Corporation 33