At the Conclusion of the Meeting, Dr s1

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Laboratory Accreditation Advisory Committee Minutes of July 30, 2003

Call to Order, Attendance, Introductions, Welcome:

The sixth meeting of the Laboratory Accreditation Advisory Committee (LAAC) was held in Room 105 of the Rachel Carson State Office Building (RCSOB). The meeting began at 9:08 a.m. Chair J. Wilson Hershey brought the meeting to order by welcoming the committee members and guests. The committee members and guests introduced themselves.

Committee members present:

Stephanie Olexa Daniel Donnelly Kathleen Maylath John Hood Anita Martin J. Wilson Hershey David Barrett Richard Eakin Stephen Morse David Allan

Department of Environmental Protection (DEP) attendees:

Richard Sheibley, Chief, Laboratory Accreditation Program Scott Perry, Bureau of Regulatory Counsel Aaren Shaffer, Laboratory Accreditation Program Jerry Winski, Laboratory Accreditation Program Ronald Houck, Laboratory Accreditation Program Michelle Rossi, Laboratory Accreditation Program Dwayne Burkholder, Laboratory Accreditation Program Carmen LaRosa, Laboratory Accreditation Program Susan Weaver, Policy Office Michele Tate, Policy Office Dennis Strain, Office of Chief Counsel Megan Dunn, Employee Development and Facilitation Consulting Renee Nease, Certification, Licensing, and Bonding

Guests: Katie King, PA Municipal Authorities Association Tracy Siglin, Exelon Generation Trevor K. Brenner, M.J. Reider Associates Phillip M. Worby, QC Laboratories Rodger Walter, PA Rural Water Association Mike McAsaus, B-H Laboratories Randy Hill, Pace Analytical Services, Inc.-Phg. Rich Hixson, Pace Analytical Services, Inc. Mike Scerkelcz, Carusce Pike Associates Joe Calabro, PA American Water Barbara Jordan, Geologic Services Corp.

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Approval of Minutes and Election of Officers:

Stephen Morse moved to approve the minutes of the May 7, 2003 meeting, and Richard Eakin seconded the motion. The motion passed unanimously.

J. Wilson Hershey was elected to his second term as the chair of the committee, and John Hood was elected vice-chair.

Draft Regulation Overview:

Richard Sheibley began by giving the committee members and guests an overview of the regulation development process as it has progressed since the first committee meeting. Mr. Sheibley stated that the Department would prepare a revised draft of the proposed regulations taking into consideration the comments received thus far. He indicated that the Department had continued to receive comments on several areas or “hot-button” issues. Some of the input has been contradictory depending on the group expressing the opinion. Those topics include the role of certified operators, laboratory supervisor qualifications, and accreditation-by-rule. The Department has decided to collect some additional information on these subjects and prepare concept papers describing possible options. Discussion on those three issues will be suspended for the July and September meetings allowing the committee to focus on the technical issues within the regulations.

Mr. Sheibley also shared that the Certification Program Advisory Committee (CPAC) has the legal charge to review any regulations they are concerned with. Given that charge, they have decided to review the LAAC regulations. The Department proposed that CPAC and LAAC have a joint meeting in December where the concept papers may be presented and discussed. The joint meeting could occur during the scheduled LAAC meeting on December 5, 2003. The committee was asked to select an alternate date for the joint meeting if December 5 did not suit CPAC. The alternate meeting was scheduled for December 18, 2003.

Mr. Sheibley then introduced the three facilitators to help with the flow of the meeting. These facilitators were asked to help direct the topics of the meeting and to allow Dr. Hershey to fully participate in the technical issues discussion.

The draft regulation discussion began with specific wording issues and typographical errors. Mr. Sheibley encouraged the committee to focus on concepts rather than specific words. The following topics and responses were brought up for discussion:

1. Whether in very specific instances, a neat material prepared by separate analysts could be used as a second source check. Trevor Brenner remarked that the purpose of the second source standard is to among other things, check the calibration standards. Concern being, that if the same source is used to verify calibration, then how would one know if it was good or bad? 2. Concern about correlation coefficients meeting 0.99 and 0.999 rather than 0.995 and 0.9995. People offered differing opinions of what was thought to make a truly good calibration curve. The Department agreed to consider all of the comments as the regulations are revised.

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3. Concern that the regulations should only offer specific acceptance criteria and requirements if the methods are not clear or do not include them, rather than forcing tighter criteria on the methods that already specify requirements. The Department clarified that the intention of the draft regulations was never to implement criteria on methods that are already very clear in their requirements. However, the draft regulations were written with the purpose of clearly outlining requirements for methods where specifics are not included. 4. Whether calibration curves should be able to be forced through the origin. The committee agreed that the laboratory should be able to force calibration curves through the origin. 5. Whether for methods that require linear dynamic range studies (LDR) results could be reported above the high standard. Much discussion was brought up around this topic. Several issues being that LDR studies are performed on the best of circumstances and only once per year. 6. Concern that laboratories do not always know the regulated discharge and/or action level. The committee agreed that the words “regulated discharge level and/or action level” should be taken out of the draft regulations. The draft regulations should include the requirement that the laboratory specify the reporting level on the client report. 7. Concern that 15% is very tight for low level checks in inorganic chemistry. People offered differing opinions of what levels should be acceptable for low-level checks. Mr. Brenner stated that the Department requires his laboratory to meet the method criteria for the ICP and ICP-MS reporting level checks, and they have had relatively no problem meeting the low level checks. The Department agreed to consider all of the comments as the regulations are revised. 8. Concern that the regulations are requiring tighter criteria than the NELAC Standards. The Department clarified that the draft regulations were written with the intention of supplying clarification and direction for the methods that have none. 9. Why an ending CCV is required even if the method uses an internal standard (IS). The committee members discussed this topic with comments such as, “If labs are required to run an ending CCV when an IS is analyzed; it will make it much harder for the laboratory.” 10. Whether laboratories could perform their own studies and petition the Department for alternate acceptance criteria for poor-performing compounds. Suggestions were made regarding how the process would be structured and how the laboratory would present its findings and documentation to the Department. Mr. Sheibley suggested having a list of known poor-performers that would be included in the regulations or guidance and allow laboratories to apply for additions to that list, with the understanding that the compounds on the list would not have to meet the requirements for other better performing compounds

The discussion regarding the calibration section was tabled until the September meeting.

Meeting Schedule for 2004 and Adjournment:

The committee decided to schedule its 2004 meetings early to assure access to Room 105 of the RCSOB from 9:00 a.m.-3:00 p.m. The following is the meeting schedule for next year:

February 10, 2003

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April 13, 2003 June 8, 2003 August 12, 2003 October 12, 2003 December 14, 2003

At the conclusion of the meeting, Dr. Hershey thanked Mr. Sheibley and the Department for being so receptive to comments and suggestions regarding the draft regulations. He commented that he has experienced the regulation process in other states, and has seen some states develop and implement regulations with little input from the public and regulated community. Dr. Hershey added that he appreciated the openness he has seen from the Department.

Dr. Hershey adjourned the meeting at 3:02 p.m.