TNI Board of Directors Meeting

TNI Board of Directors Meeting Summary

December 13, 2017

1. Roll Call

The Board expresses their condolences for the passing of Ken Jackson’s wife.

2. Approval of November 2017 Minutes

Motion to Approve: Jack Farrell

Second: Dave Speis

Approved: Unanimous

3. PowerDMS Demo in Albuquerque (Attachment 1)

On November 8, Jerry Parr attended a demonstration of a new software product called Power DMS

(powerdms.com). It seemed very impressive, and on December 6, we had a follow up meeting

attended by William Daystrom, the TNI Finance Committee, and Suzanne Rachmaninoff.

There is now pretty good consensus that this software could be a powerful tool for labs, ABs, and

even TNI. For everyone, it is a strong document management system. For labs, it contains some very

strong tools to help labs demonstrate compliance with the Standard by linking language from the

Standard to the lab's internal QM and SOPs. For ABs, it would contain the same tools for the AB to

show compliance to Volume 2, but also would help with the lab assessment piece. For TNI, this could

Directors

Present

Jordan Adelson

Aaren Alger

Steve Arms

Justin Brown

Jack Farrell

Chris Gunning

Myron Gunsalus

Daniel Lashbrook

Judy Morgan

Cheryl Nolan

Lara Phelps

Patsy Root

Debbie Rosano

Scott Siders

Alfredo Sotomayor

Dave Speis

Past President

Sharon Mertens

Staff

Lynn Bradley

Carol Batterton

Ken Jackson

Jerry Parr

Ilona Taunton

Janice Wlodarski

TNI Board of Directors Meeting Summary

December 13, 2017 page 2

replace our current use of Dropbox, with a much stronger document management system. Initially, we

could just use this within TNI to replace what we do in Dropbox, but with time, we could use it for

standards development and for AB evaluations. William currently has a trial version and is going to

compare this product to Microsoft’s SharePoint, another document management system.

Based on our initial discussions, we have asked them to provide a demo during the Albuquerque

meeting. ABs, the TNI Board, and senior staff to participate. The meeting will take place from

12:00N – 1:30 pm on Monday and lunch will be provided. PowerDMS will also be exhibiting Monday

and Tuesday.

Here is a link to the original 40-minute demo, which gives an overview of the software. You do not

need to view this as it will be repeated in Albuquerque.

https://drive.google.com/file/d/1-4krusoMLdJSI7KWIyxtDsOprm9A4N_s/view

We plan to approach this in two steps. Phase 1 would be to enter into a partnership agreement to

license PowerDMS to sell the TNI Standard. This appears to be a low-risk and high-potential step.

Phase 2 would be for TNI to use PowerDMS internally. This step has a financial component of

approximately $1200 per year and we want to see if SharePoint would be a better solution. We would

not embark on Phase 2 until after the demo in Albuquerque and after William evaluates this service.

Attachment 1 contains key excerpts the draft partnership agreement.

Motion to Enter into a Partnership Agreement with PowerDMS (Phase 1): Patsy Root

Second: Myron Gunsalus

Approved: Unanimous

4. SOP for Review

SOP 1-104, TNI Document Control

Revision 1 of this SOP was approved by the Board in 2012. This latest revision contains many minor

changes to reflect actual practice as well as more use for on-line (cloud) storage of documents. The

most significant change is in Section 5.2.2 relating to Advocacy Committee documents. Lara’s

comments from September have now been incorporated.

Motion to Endorse SOP 1-104: Patsy Root

Second: Jack Farrell

Approved: Unanimous

5. Drinking Water Memo on MDLs

From the November Minutes:

EPA’s Office of Groundwater and Drinking Water has released a memo to unknown groups that relate

to implementation of the new Part 136 procedure for drinking water. ELAB has received a copy as

well as likely many states and regions, but it does not appear to be published anywhere.

This memo has several issues in it that are likely controversial and at least one TNI Board member

has asked to Board to discuss this memo.

TNI Board of Directors Meeting Summary

December 13, 2017 page 3

This is probably more an ELAB issue than anything for TNI to get involved in. It could also be an AB

issue as it could possibly be in conflict with the TNI Standard. It would be great if the ABs could keep

us informed regarding what the other Regions are saying. Aaren may have some more information by

the next Board meeting.

This month’s update:

Last week all Region 3 state labs and accreditation programs from Region 3, etc. met; Dan Hautman

was in attendance. He confirmed the document that was circulating was developed by his group and

it is accurate as to how the EPA Drinking Water office would expect the drinking water MDLs to be

handled.

Will this be released to the general public? It was made available to the Regions and the Regions

were to give it out. Can EPA put together as an official document and make it widely available? Aaren

can check.

Is it mandatory to use the new procedure or is it one of those “should” things? This didn’t come up but

the way Aaren reads it is if the method or anywhere in the program or some requirement talks about

Appendix D 40 CFR Part 136, then the new Appendix D procedure is what this is referencing – this is

her understanding.

Maybe the best advice is, if you’re a lab, contact your AB and find out if it’s mandatory or not.

Jerry will write up recommendation and provide to the Board for approval via email.

6. New NGAB Application Underway

On November 8, International Accreditation Service, an ILAC-recognized Non-Governmental

Accreditation Body located in California, initiated the process to provide an application to become

recognized by TNI to accredit laboratories to the TNI Standard. As of last Friday, they had mostly

completed the evaluation checklist and provided a number of documents for the Lead Evaluator

(Ilona) to review. We anticipate the on-site assessment to occur early next year.

7. Environmental Sensors Meeting

Sharon attended a meeting in DC with ANSI at EPA to talk about the environmental sensors. The

stated purpose of the meeting was to provide EPA and others with the perspective on how standards

and conformity assessments could help with producing quality data from environmental sensors

technology, and to help customers understand what devices meet their needs.

There was a lot of discussion around why this is now important. EPA pointed out that soon they will

be the minority provider of environmental data. There are more and more citizens, monitoring groups,

states and local environmental monitoring networks, and a lot of this data is not coming from the

traditional regulatory resources. The idea was presented that maybe in the future we may not have 40

CFR methods any more – this may be a reality at some point in the future.

Sharon put on the table the expertise that we have and our ability to develop an overarching

standard, that we have used the ISO standards as a basis for developing consensus-based

standards. If there was a demand for it, TNI could potentially work with volunteers and the ISO

standard to develop a more applicable standard for environmental sensor monitoring. There are still a

lot of unanswered questions about this, and from Sharon’s point of view, EPA is very supportive of

seeing this happen and that’s encouraging. They may not, however, be particularly interested in

supporting it, either from a regulatory or a financial standpoint. There was not a lot of specific

discussion about this, however, so she is not sure.

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December 13, 2017 page 4

EPA staff thought the next step may be to pick a water parameter and an air parameter, look at the

classic technology(s) that are around right now, and look at a single or several sensor technologies to

see what it would take to put this into a model. Jerry has received a request for some information

from EPA and we’ll be putting something together for them shortly.

8. Program Reports (Attachment 2)

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Attachment 1

Excerpts from the Draft Content Publication Agreement

You hereby grant us a non-exclusive license to use, copy and store the TNI Standards, and to transmit and

display the TNI Standards through the Service to those customers who purchase a subscription to the

Service, to the extent reasonably necessary to provide, maintain and improve the Service. Each of us

authorizes the other to use any trademarks, service marks, trade names, proprietary logos, domain names

and any other source or business identifiers in connection with the authorized use of the TNI Standards

through the Service and the marketing and sale of the Service for use in conjunction with the Content.

You agree to provide us with a complete and accurate copy of the TNI Standards in electronic form, as well

as timely updates of the TNI Standards necessary to keep the TNI Standards complete and accurate.

You have sole responsibility, and we assume no responsibility, for the TNI Standards.

You acknowledge, and authorize our representation in our advertisements and marketing materials,

that our PowerStandards software assessment tool is an acceptable method for establishing

compliance against your accreditation standards.

You retain all rights in your Marks and TNI Standards. We retain all rights in our Marks and the Site, the

Service, and the Software.

Joint Marketing Addendum

This Addendum constitutes:

• Your confirmation that our PowerStandards software assessment tool is an acceptable method

for establishing compliance against your accreditation standards;

• Your agreement to provide access to your mailing list of subscribers, or otherwise to facilitate

communications between us and your subscribers;

• Authorization of press releases and advertisements respecting the use of the Content with the

Service;

• Authorization to use any Marks for such marketing purposes;

● Your agreement to participate in training sessions which may include: webinars developed and

coordinated by PowerDMS, customer presentations, user group sessions, etc. at a time mutually

agreed upon by the association and PowerDMS;

• Authorization to use a sample of your standards in a free trial experience site for prospective

subscribers;

Member Enrollment Addendum

During the term of the Agreement and subject to the Service Terms, we will offer our PowerStandards

software assessment tool to each of your customers at an annual fee of $1,150 per manual. Those of your

customers which purchase a subscription for our PowerStandards software assessment tool will also be

granted complimentary access to these PowerDMS training services: (i) self -paced learning portal (ii) live

monthly training webinars, (iii) online self-help training videos and quick sheets, and (iv) our service desk for

questions/assistance.

TNI Board of Directors Meeting Summary

December 13, 2017 page 6

Attachment 2

PROGRAM REPORTS

CONSENSUS STANDARDS DEVELOPMENT

• The Chemistry Final Standard (V1M4) has been formatted and is now complete. A response-to-

comments document from its Voting Draft Standard was published on the TNI website and all

commenters were individually informed on the disposition of their comments. The next stage was then

followed in the process for ANSI to designate it as an American National Standard. Notice of the

completed standard appeared in ANSI’s publication Standards Action on December 1, and the public may

request the opportunity to review the standard through January 15, 2018. Thereafter, we will submit final

documentation detailing the votes received, composition of the Consensus Standards Body (i.e., the

Chemistry Expert Committee), etc. On receipt of ANSI’s final approval, the ANSI logo will be added to the

cover pages of the module and the entire volume.

• The Chemistry Expert Committee requires little additional work to complete its V1M4 guidance

documents. It is planned to discuss them at the January Albuquerque meeting and finalize them soon

after.

• The Consensus Standards Development Executive Committee is continuing its update of SOP 2 -101

(Procedures for Expert Committee Operations), to bring it more in tune with SOP 1 – 101 (Operation of

TNI Committees) that applies to all non-expert committees.

• The Laboratory Proficiency Testing (PT) Expert Committee has completed its portion (V2M2) of the

Accreditation Body checklist. It will be forwarded to the Accreditation Council following proof-reading.

• The Laboratory Accreditation Body Committee members continue reviewing the draft updated ISO/IEC

17011, along with TNI language from the current Volume 2 combined modules 1 and 3 plus all comments

received thus far, in order to facilitate the creation of a revised, updated Module 1 for Volume 2 of the TNI

Environmental Laboratory Sector Standard.

• The WET committee did not meet in November, but will have a rescheduled meeting prior to this Board

meeting. Following some one-on-one conversations at the November Society for Environmental

Toxicology and Chemistry (SETAC) meeting, the committee is finalizing its response to some technical

issues raised by EPA’s Office of Wastewater Management, following the ELAB/EPA/TNI meeting at

conference in DC.

• Committee members are beginning to draft revisions to the WET module of the standard. The major

revisions are expected to be in requirements for initial and ongoing demonstrations of competency and

appropriate QA/QC requirements for the water quality chemistry measurements used in WET testing.

• The Radiochemistry Committee is continuing work on review of the procedures used to update

Radiochemistry FoPT limits. Keith McCroan and Bob Shannon will receive PT date from Carl (Chair,

Chemistry FoPT Subcommittee) and calculate limits based on a new procedure Keith is proposing. The

target completion for this work is March/April 2018. The committee is continuing to develop the course

being offered to assessors, ABs and labs at the Albuquerque meeting in January. The Committee has

voted in three new members:

o Velinda Herbert (Lab - EPA)

o Brian Miller (Other - PT Provider)

o Terry Romanko (Lab)

• The Microbiology Committee discussed streamlining method codes and new committee membership.

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December 13, 2017 page 7

• The Quality Systems Committee completed the Final DRAFT of the Small Laboratory Handbook. There a

few minor updates that are expected on Tuesday and then the document will be sent to Jan for

finalization. The committee will take one last look after Jan completes her review. The committee will be

working with the CSDP Executive Committee to extend Paul Junio’s term on the committee through 2018.

The committee is also looking at new membership.

NEFAP Executive Committee

• The committee carefully reviewed the combined evaluation SOP during their November meeting and

provided comment. Paul Bergeron will participate on a small subcommittee to help update the more

detailed evaluation list of things to review (Appendix E of the combined evaluation SOP). A volunteer from

PTEPC has also been requested. Paul thinks the more detailed list will help with consistency between

evaluations.

• The committee continued to discuss the formation of the Mobile Laboratory Task Force. Kirstin, Justin

and Paul are talking to candidates for the Task Force and they hope to have it formed in December.

• The committee will be focusing on Strategic Planning over the next few meetings.

• The review of an old FAQ document still needs to be added to an agenda, but other priorities have taken

precedence,

Field Activities Expert Committee (FAC)

• The committee did not meet in November due to committee member schedule conflicts.

• The Scope Guidance Subcommittee: This needs to be reviewed and sent to the Policy Committee prior to

finalization.

• The committee did not receive any response regarding the originally scheduled webinar after mailing out

information to interested parties. This webinar will be rescheduled after the first of the year when

hopefully people’s schedules will be better to attend this public meeting to receive comment on the Field

Standard.

NELAP

Accreditation Council

• For the current round of evaluations, nine renewal letters have been issued thus far. One renewal

recommendation is being voted upon by the NELAP AC and is expected to pass, with a second

recommendation due shortly. The other seven applications are in various stages of review, with one

additional site visit scheduled in 2017.

• The Council also initiated its vote to approve the recommendation from the Laboratory Accreditation

Systems Executive Committee (LASEC) to accept the most recent revision of the Chemistry module of

the 2016 TNI Environmental Lab Sector Standard. We anticipate that this will pass. The next stages of

review will begin formally with the LASEC’s recommendation about the final formatted package of

Volumes 1 and 2, about whether to adopt the standard, and then an implementation date can be

established. Availability of the promised guidance about the chemistry module may impact the

implementation date.

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December 13, 2017 page 8

Laboratory Accreditation System Executive Committee (LASEC)

• LASEC reviewed the most recent revisions to the Chemistry module and forwarded its recommendation

to accept those revisions to the NELAP AC.

• Committee members are working with staff who supported the Mentor Session at conference in DC,

about creating final write-ups of the implementation guidance. Planning for Mentor Session and

Assessment Forum session in Albuquerque is underway, with the Mentor Session being some form of

follow-up to the DC session.

• LASEC has finalized its “lessons learned” as goals and recommended actions, and will soon share this

document with the NELAP AC, CSDEC, and possibly the TNI Board. Where appropriate, changes will be

made to LASEC’s Standards Review SOP 3-106.

• LASEC is reviewing a draft policy for de-coupling the NELAP AB recognition certificates from the

evaluation process, as requested by the Accreditation Council, and is also seeking input from committee

members and the Council about developing the Conflict of Interest SOP, as directed by the Board.

PROFICIENCY TESTING

• FoPT Table Format Subcommittee: The IT Committee reviewed input from the NELAP AC and the

preference to use the naming associated with the CAS number. It was determined that the FoPT tables

will follow LAMS since the ABs work from LAMS. The PTPEC will be notified prior to changes being made

in LAMS. There is discussion in the IT Committee to link FoPT Tables and LAMS so that nomenclature

changes could be automated.

• Analyte Request Application (ARA) – NPW/SCM Qualitative PCB Analysis: The Chemistry FoPT

Subcommittee prepared DRAFT language to the PTPEC to resolve the ARA. Nicole (PT Expert Chair)

was concerned that the language may not solve the issue and that there may be a conflict with Volume 3

of the Standard. She met with Rachel Ellis (NJ – author of ARA) to discuss the issue. It was determined

that the proposed footnote would not change how PT Providers score the 7 individual PCB Aroclors, so

there would be no conflict with the Standard. It was also noted that the 2009 Standard (V3:10.2.2) and the

2016 Standard (V3: 5.9.2.2) allow the FoPT table to trump the Standard when it comes to evaluation

criteria if a situation arises where the FoPT table is in conflict with the Standard. Nicole is recommending

that the PTPEC accept the new footnote wording at their December meeting.

• Radiochemistry FoPT Table Update: The Chemistry FoPT subcommittee discussed alternate procedures

for reviewing and updating the Radiochemistry FoPT Table. Keith McCroan (EPA, Radiochemistry Expert

Committee) and Bob Shannon (Chair, Radiochemistry Expert Committee) lead the discussion. The

committee concluded that they would like to understand the impact of a new procedure as described by

Keith, so he will take the radiochemistry data and apply the proposed procedure. The committee will

compare these results to those developed using the current procedure and decide how to move forward.

This will take some time to prepare, so the committee does not expect to start work until March/April

2018.

• Microbiology FoPT Table Update: The Committee Chair has been buried in work and will begin reviewing

the data. She plans to have a report for the December meeting.

• The PTP/NEFAP Evaluation Workgroup: Each of the Executive Committees reviewed a DRAFT of the

combined procedure that incorporated the written comments received from the Executive Committees.

This DRAFT was reviewed by Webex to show how the written comments were incorporated. A Final

DRAFT was distributed to each committee for vote during their December meetings. The next steps

include finalizing the application, updating Executive Committee Evaluation SOPs to point to this

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December 13, 2017 page 9

combined procedure, finalizing the evaluation checklist and reviewing current recognitions to extend

effective dates as needed.

• PTP SOP Subcommittee: The subcommittee is still working on SOP 4-101 – FoPT Table Updates. SOP

4- 102 (Complaints) was sent to the PTPEC for final vote after Policy Committee comments were

addressed. This should be completed during the PTPEC December meeting.

• The PTPEC is continuing to work on the formal complaint received regarding 4,4’-DDD PTs. A complaint

subcommittee was formed following the PTPEC complaint procedures with Andy Valkenberg, Susan

Jackson and Nicole Cairns selected as members. The subcommittee has requested data to review this

issue and Maria is working on a request to receive the data from the PT Providers.

ADMINISTRATION

Advocacy Committee

• The Advocacy Committee reviewed accomplishments for 2017 and planned activities for 2018 for their

report at the Albuquerque meeting.

• The committee worked on a draft position statement on quality systems and resurrected two other

position statements for Board approval.

Policy Committee

• Policy Committee continues with review of current revisions to program documents, but none have been

finalized this month. For now, the five-year reviews of the various administrative SOPs and policies

originating with Policy Committee are suspended until current new and revised policies and SOPs can be

reviewed.

Training

• A number of new training courses are being worked on:

o Sample Collection (Silky Labie – The course will emphasize the importance of collecting samples that

represent the source matrix and maintaining the integrity of the sample until delivery to the laboratory.

This will be an 8-hour course being planned around March 2018. A final date has not been selected

yet.)

o Technical Training Series (Marlene Moore – 6 classes 4 hours for each class. The dates have been

set for:

- Technical Training Series – General Chemistry Methods – May 24

- Technical Training Series – Microbiology Methods – March 23

- Technical Training Series – Drinking Water Methods – April 20

- Technical Training Series – Wastewater Methods – February 23

- Technical Training Series – Soil Methods – June 12)

o Good Laboratory Practice – Glassware (Marlene Moore – 2-hour course. This course is being offered

on January 11, 2017 at 11am Eastern. There are currently 16 individual registrations and 9 Group)

o Good Laboratory Practice – Internal Audits (Matt Sica – Self-paced course. Planned for January

2018.)

TNI Board of Directors Meeting Summary

December 13, 2017 page 10

• The course “What Does QC Data Tell Me ... and Why Should I Care?” occurred on November 14, 2017.

There were 55 individual registrations and 10 group registrations.

• Registration is open for “Understanding Radiochemistry: Ra-228 and Gas Proportional Counting”. The

course will be held onsite at the Albuquerque meeting and presented as a Webcast afterwards. It will be a

6-hour course taught by members of the Radiochemistry Expert Committee. It is intended for assessors,

ABs and laboratories. The committee will review response after the class and decide whether to prepare

additional courses using other technologies.

Forum on Laboratory Accreditation

• We have now met our room block requirement.

• We are over 100 attendees, but many Directors and Committee Chairs have not registered yet.

• Mentor Session -- Monday afternoon, working on Implementation Guidance.

• 6 topics (possibly 9?) chosen from among.

o topics needing additional content after DC session

o list of "leftover" topics from CA

o suggestions from Paul Junio and Small Lab Handbook

• Assessment Forum

o A2LA/Dade Moeller re top findings in CA assessments (and related "stuff")

o Presentations from CA labs about progress

o Tie discussions to how same issues affect other ABs and state certification bodies -- maybe around

Technical Director qualifications and 1 or 2 PTs/year, in particular, and possible future changes to TNI

Standard.

NEMC

• Jacksonville is the confirmed location for NEMC 2019.

• Almost all of the keynote and plenary speakers for NEMC 2018 in New Orleans have been identified

and confirmed.

• The email and post card call for abstracts has been sent out.

• APHL has submitted a proposal for a session entitled “Public and Lab Partnerships for Environmental

Health”.

• Registration for the exhibit program has opened.

Additional Administrative

• Internal Audit Checklists: All audit checklists were given a final review for format consistency and updated

SOPs were reviewed for possible updates to the checklists. Updated checklists were sent to the Program

Administrators to confirm the updates. All updates are complete and have been sent to William with a

request to evaluate whether a form can still be updated for input rather than having to upload the Excel

spreadsheets.

• The Quality Manual template has been updated to the 2016 Standard requirements in the document and

it is now available on the TNI website as the current template.

Active Members: 1152

• There was one new committee application received. It was for multiple committees including: LAB,

Chemistry, Quality Systems or Radiochemistry.