Summary of the 2012 Forum on Laboratory Accreditation
August 6-9, 2012
This summary is based on notes taken at the closing session of the TNI meeting on August 9. An appendix provides a list of presentations that are posted on the website.
1. Environmental Measurement Methods Expert Committee
· Received comments on its Working Draft Standard (WDS), and will be re-thinking how to handled a failed calibration for non-detects.
· Renamed committee to Chemistry Committee
2. Field Activities Expert Committee
· Discussed SOPs and advocacy. Received comments on WDS, on scopes and PT (V1 & V2).
· Requests that the website note about accepting comments say the comment period is extended until August 22.
3. Laboratory Accreditation Body Expert Committee
· Discussed progress on assignments from the original ABTF.
· Option #2 is being addressed first with development of a generic application for laboratories. Progress on the database development plan has been suspended until the Database Administrator completes work on the method code changes required by EPA's Methods Update Rule (MUR) and possible other priority tasks, but a few new ideas were offered in comments.
· Option #4, Third-Party Assessors (TPAs,) began its discussion by exploring credentialing of TPAs as directed earlier, but with comments and feedback from discussion, reached consensus that it should proceed step-wise, beginning with a list of individuals and ABs available to perform assessments under contract to NELAP ABs, and then move forward. A proposal for Board consideration should be forthcoming soon.
· Option #7, changing the Standard to a 5-year reassessment period and utilizing surveillance assessments, continues to be problematic. The NELAP Accreditation Council (AC) has concluded that it does not want to change the reassessment time due to potential problems with obtaining travel approvals, and the preponderance of small labs for which such a change would use more resources although for large labs, resources would be saved. The possibility of changing to match the mandatory 3-year cycle of site assessments for drinking water, defining possible alternatives to surveillance assessments being site visits, and rewarding good-performing labs with fewer assessments remain to be considered, but for now, no change to the Standard is recommended.
4. Quality Systems Expert Committee
· Responses to the Voting Draft Standard (VDS) comments were discussed (Modules 2 – 5, but not 6 & 7). QS will utilize the changes being recommended by the Corrective Action Workgroup and the draft SOP that should be presented to the Board in September, as process for completing work on this Standard. That will include a step with feedback to the commenters plus presentations to LAS EC and the AC.
· Two new committees were tentatively formed during the conference – a Microbiology Expert Committee chaired by Robin Cook, and a Radiation Expert Committee, chaired by Bob Shannon. CSD EC approval of these has begun and once finalized, Board approval will be requested.
5. Proficiency Testing Expert Committee
· The committee received many comments on Volume 1 (V1) and Volume 2 (V2) WDSs, so that an extensive rewrite will be needed. This is likely to continue until Denver. Then it plans to begin Volume 3 (V3) which will likely be based on ISO/IEC 17043, making critical requirements from applicants based on 17043. After that Standard is written, the committee plans to redo guidance and the 4th volume (PT oversight). All PT vendors are already accredited to 17043, but are using procedures for making and scoring the PTs that are based on old EPA requirements that allow no change, but all want changes able to be made.
· Two Standards Interpretation Requests (SIRs) are pending response and then will be returned to LAS EC for voting by the AC. Mitzi also noted that the Temporary Interim Amendment (TIA) for Whole Effluent Toxicity Testing (WETT) PT was adopted by the AC.
6. Stationary Source Audit Sampling Program
· The committee is developing an SOP similar to the Field of Proficiency Testing (FoPT) SOP, to address changing, adding or removing analytes, and expects a vote to adopt this SOP at its next meeting. It is also preparing recommendations to improve Method 25, for submission to EPA with a request that the Agency make the recommended changes. Once that happens, the committee will make the changes to the SSAS Standard.
7. Consensus Standards Development Executive Committee
· The EMMEC will be renamed the Chemistry Committee. It and the Microbiology and Radiation committees will have responsibility for defined parts of what was formerly handled by Quality Systems, and CSD will coordinate and oversee to ensure that all aspects are addressed. The committee also expects to adopt and recommend to the Board modifications to SOP 2-100 (Procedures Governing Standards Development) based on the Corrective Actions Workgroup efforts, with additional input from the LAS EC, for the purposes of improving consistency and conformity.
8. National Environmental Field Activities Program Executive Committee
· NEFAP adopted three new SOPs that are being implemented immediately, pending Policy Committee approval. It is also filling positions for a Recognition Subcommittee (as described in one of the new SOPs). The currently recognized ABs have no Field Sampling and Monitoring Organizations (FSMOs) applying for accreditation yet and this is believed to be due to concerns about cost, etc. Louisiana has provided wording for use by NEFAP and is in process of modifying its standard (or regulations?) to encourage use of other FSMO accreditation programs.
· The Chair specifically requests that we distinguish between the FSMO Standards and the Environmental Laboratory Sector (or NELAP) Standards, when speaking about "the TNI Standard."
9. National Environmental Laboratory Accreditation Program Accreditation Council
· Ongoing updates show that:
o progress in AB implementation of the 2009 Standard is stalemated;
o evaluations of NELAP ABs for renewal of recognition are proceeding on schedule;
o some progress has been made on commitments from the Sarasota meeting, making contact information for complaints explicitly available on the website for all NELAP ABs and meeting with non-NELAP ABs;
o discussion of coordinating and harmonizing Fields of Accreditation occurred, but is stalemated by state restrictions; and
o the ABTF option about using DoD and DOE assessment reports has been addressed and a memo to the Board will follow.
· Other major efforts have been:
o the formation of a "quick response subcommittee" to systematically address the backlogged SIRs and working with the IT committee to address method code changes required by EPA's MUR;
o productive discussion with the PT Expert Committee chair helped resolve some outstanding issues, and extensive discussion about incorporating non-governmental ABs (NGABs) a national accreditation program helped all parties better understand some aspects of what has proven to be a highly emotional issue; and
o Steve Stubbs of Texas, Vice Chair of the AC, is retiring at the end of August.
10. Laboratory Accreditation Systems Executive Committee
· Option #6 from the ABTF report, Information Sharing, was discussed further, the three areas from Sarasota. One of the areas for which an SOP was planned, sharing of assessors among ABs, turned out to be current practice already so the NELAP ABs have no desire for a specific SOP – their individual state practices are sufficient at present.
· Out of 206 SIRs submitted, 110 have been closed, with 90 outstanding (4 are unaccounted for?). In reviewing the process, it appears that the Expert Committee interpretations are not being reviewed by LAS EC per the SOP; this will occur going forward. A suggestion was made that, for "needs discussion" SIR votes, the Expert Committee chair should be included in the AC meeting when SIRs are discussed.
· LAS will review the recommendations of the Corrective Action workgroup and expects to send that outcome to the Board. Going forward, LAS will perform a "suitability review" of environmental lab standards, not duplicating the proposed editorial review and not repeating the consensus process either. The QS WDS will be ready for review first, it appears.
· Ms. Daigle (current LAS EC Chair and former Chair of PT Expert Committee) noted that there are four standalone sets of definitions in the NELAP Standard, and that these ought to become a standalone glossary for the TNI ELS Standard. This suggestion will be conveyed to the CSD EC.
11. Technical Activities Committee
· Attendance was slow, perhaps due to conflicts with other scheduled meetings. The committee discussed mentoring topics, assessor training guidelines, laboratory training guidelines, and the new educational delivery system.
12. Assessment Forum
· Firstly, the draft report of the Corrective Action Workgroup was well received, with a few valuable suggestions from participants.
· Three NGAB representatives addressed traceability from different perspectives.
· Open discussion addressed perceived differences between the TNI NELAP/ELS Standard and ISO/IEC 27025, noting that calibration is not addressed by the TNI Standard. It's omitted, not provided, and identified as "not applicable." A NGAB representative was invited to explain to QS why this should be handled differently in the new Standard under development now, and possibly other issues.
· Lastly, Keith Chapman of the Small Laboratory Advocate Group gave a presentation.
13. Proficiency Testing Executive Committee
· PT Provider (PTP) Assessments are coming up. ACLASS has now been approved as a PTP for the SSAS. Efforts are underway to rejuvenate the PT Micro subcommittee and the Chemistry subcommittee is reviewing its FoPT table, with consideration to whether NELAP and non-NELAP FoPTs should be included.
· Several database issues were addressed. A subcommittee is determining what information TNI needs to evaluate the PT program (which checklist items pertain to databases). A crosswalk between databases will be needed.
· And, beyond the Committee's purview is the larger philosophical question of PT database management. The complaint concerning this issue has now been resolved, but there are further actions to be taken regarding the PTP list so that the PTP ABs are consistent and approvals from both ABs can be linked. There may be other issues specific to micro PT.
14. Accreditation Body Task Force Two
· The ABTF II met to present a report of activities to date. Then, in another session, the TF and the NELAP AC met for a panel discussion with five NGABs (Perry Johnson, A2LA, LAB, ACLASS and AIHA). Both meetings involved lively input from both TF members and meeting attendees.
The TF has determined the following:
o The NELAP AC process for evaluation of state ABs could be used, with minor modifications, for evaluation of NGABs.
o Under ILAC, NGABs can follow home government requirements without jeopardizing their recognition. This will facilitate resolution of some issues.
o There are various ways to manage information exchange between state ABs and NGABs, including such things as MOUs, conditions of accreditation, etc.
o A number of potential concerns, including the difference between compliance assistance and consultancy, NBAB enforcement activities, public access to laboratory accreditation records, the potential need to modify AC business rules, and issues of impartiality, can likely be addressed without major difficulty.
The big issue with approval of NGABs is whether the approval body could be the NELAP AC, a combination of NELAP and NEFAP, or something else. The TF asked NELAP ABs if they would be able to approve a NGAB as meeting the TNI Standard or to become a member of the NELAP AC. Five of the twelve ACs who responded said they would not be able to do so. This position is articulated in a recent APHL Position Statement. Approval as a TNI AB and mutual recognition are currently part of the same process. We need to explore whether the answers would change if they were separated.
· While progress has been made, there is a need for further discussion, including more in-depth discussion with NGABs, a better understanding of the APHL position paper, and exploration of options for NGAB recognition and approval processes.
· The ABTFII requested feedback from the Board concerning whether they wish the TF to continue as proposed and any recommendations for how to more effectively address these issues.
15. Advocacy Committee
· In order to comply with the request of the Policy Committee, the planned "position papers" will need to be renamed. Advocacy will work to prepare an SOP for discussion in Denver. These documents, however named, will articulate TNI basic beliefs.
· Advocacy also discussed:
o TNI's response to the FL RFI (with Mr. Arms recusing himself);
o the MUR;
o offering training in how the twelve quality control parameters described in the TNI NELAP Standard can address the requirements of the MUR;
o newsletter editor and items for a fall issue; and
o partnering with AWWA (American Water Works Association) in a discussion website.
· Ms. Duncan noted that, with there now being a new Past Chair of the Board, she will be stepping down from Advocacy and Mr. Arms will assume the Chair role.
· A separate meeting, hosted by Advocacy, was held to encourage governmental-but-non-NELAP ABs to participate in TNI and to explain progress made in recent years, as well as to listen to their concerns about the NELAP program. This meeting is expected to repeat at future NEMC/TNI meetings, and the presentations offered may be re-created as a webinar through TNI's educational delivery system. (NOTE: please advise APHL's National Laboratory Training Network if/when this becomes available.)
16. Corrective Action Workgroup
· This group was chartered by the Board in 2011, to improve the process of standards development for TNI by examining and determining how best to correct the processes that led NELAP to difficulties in implementing the NELAP Standard. A presentation during the Assessment Forum, based on the workgroup's draft report, provided opportunity for feedback. The workgroup identified four recommendations:
1. Examine the process from comments on the VDS to the final Standard, and add an additional step of feedback to commenters for clarity and to determine whether the "fix" addressed the comment.
2. Form an "editorial board" to review Standards for consistency with the purposes of ISO and ANSI, as well as for possible omissions and other issues that might be detected.
3. Examine the AC and LAS procedures, to find ways for earlier review and input from these groups, between the WDS and VDS at minimum.
4. Develop better mechanisms for tracking "parking lot" issues.
The workgroup will provide an updated SOP addressing these recommendations, and once that is adopted, SOPs of the CSD, LAS and AC will need review for consistency with the changes. Even allowing time for additional suggestions and feedback from the AC, a final report should be available to present to the Board in September.
17. Conference Planning Committee (Jerry Parr)
· Based on requested times just presented to the Board, and three concurrent sessions beginning at 8 am, the committees' needs could be addressed in a 3 ˝ day meeting. If there can be four concurrent sessions at some times, it might be possible to hold the meeting to 3 days.
· The next combined meeting (NEMC & Forum on Laboratory Accreditation) will be in San Antonio, TX, August 2013, and it looks very likely that the Winter 2014 Forum meeting will take place in Louisville, KY. Bids have not been requested or evaluated yet, but Louisville provided a tempting proposal for an earlier meeting so it may do so again. An additional half-day workshop on the DoD QSM5 will be offered. (NOTE: Zonetta English is already plotting how to entertain us!)
18. Information Technology Committee
· Over lunch, the committee addressed method codes in non-NELAP AB settings, and some LAMS issues. Additionally, an early morning meeting was held with the AC and representatives of both EPA Drinking (Dan Hautman, OGWDW/TSC) and Waste Water (Lem Walker, OST) programs to discuss MUR issues and more.
19. Policy Committee
· Requests lunch meeting in Denver.
· The committee reviewed three guidance documents and discussed the Advocacy Committee's response to its comments about position papers.
20. Environmental Laboratory Advisory Board (ELAB)
· Not a TNI group, but typically holds in-person meetings for half day during Forum conferences.
· Workgroups of ELAB addressed level of quantitation (LOQ) issues, activities and a web-published report on national accreditation with a summary document as well as recommendations that will be provided to EPA as a result of the Board's activities.
· ELAB also hosted a lunch with Mike Shapiro, EPA Office of Water manager, to discuss Data Quality Objectives (DQOs), the MUR and the renamed Chemistry committee. Mr. Shapiro indicated he was open to consensus solutions to the "method detection limit" problem.
· ELAB members also participated in the Advocacy Committee's meeting with Office of Water representatives.