Laboratory Accreditation Advisory Committee (LAAC)
Minutes of October 16, 2007
Call to Order and Attendance
The October 16, 2007 meeting of the Laboratory Accreditation Advisory Committee (LAAC) was held in the conference room of the PA DEP Bureau of Laboratories (BOL). The meeting began at 10:07 A.M. Chair Dr. J. Wilson Hershey called the meeting to order by welcoming the committee members and guests. The committee members and guests introduced themselves.
Committee members present:
Anita Martin Chester Water Authority
J. Wilson Hershey Ph.D. Lancaster Laboratories, Inc.
Kathleen J. Maylath PPL Generation LLC
David Barrett Mahaffey Laboratory LTD
Stephen Morse, P.E. Skelly and Loy, Inc.
Gene Greco Western PA Water Pollution Control Association
Edward Chun, Ph.D. General Public Member
Department of Environmental Protection (DEP) attendees:
Aaren Shaffer Alger Chief, Laboratory Accreditation Program
Scott Perry Bureau of Regulatory Council
Daniel Lapato DEP Office of Policy And Communications
Ali Tarquino-Morris Laboratory Accreditation Program
Bethany Piper Laboratory Accreditation Program
Guests:
David Piller EPGA and Exelon Generation Co., LLC
Sarah House Lancaster Area Sewer Authority
Discussion of New Membership/Renewal of Membership
Three LAAC members resigned from the committee: Chair Dr. J. Wilson Hershey (representative of a Commercial Environmental Laboratory), Dr. Edward Chun (General Public Member), and Ms. Kathleen J. Maylath (representative of an Industrial Environmental Laboratory). Ms. Kathleen Maylath recommended David Piller, Environmental Specialist, Exelon Generation Co., LLC to serve as her replacement on the committee.
LAAC members Ms. Anita Martin, Mr. David Barrett, Mr. Stephen Morse, P.E., and Mr. Gene Greco indicated that they would serve the next term on the committee. Ms. Alger informed the committee that Dr. Stephanie Olexa would serve the next term.
Election of Officers
The officers for the next term were not elected during the meeting due to a lack of majority. Mr. Stephen Morse was elected to serve as the Chair for the meeting. Officers will be elected during the first meeting of the new term.
Review of Bylaws
The question of whether an alternate designated to the LAAC by a committee member could vote was raised. Ms. Alger said that an alternate on the LAAC could vote once per year.
The committee did not propose any changes to the LAAC bylaws.
Upcoming Meeting Schedule
Ms. Alger proposed that the next meeting in December be cancelled and suggested that the LAAC start with the next meeting in March when the new membership begins its term. The motion to cancel the December meeting was passed. LAAC meetings will be held the second Thursday of the month. Ms. Alger indicated that members would be contacted through e-mail and PA Bulletin notices for the next meeting.
Compliance Assistance Update
Ms. Alger presented an update of changes to the BOL management. Dr. Roger Carlson retired as Bureau Director and Mr. Gary Niland was acting as the Bureau Director until the permanent replacement was named. Dr. Martina McGarvey was acting as Technical Director of the laboratory. Dr. Martina McGarvey was named Bureau Director. Dr. McGarvey oversees the DEP Laboratory and the Laboratory Accreditation Program (LAP). The BOL was in the process of hiring a new technical director to replace Dr. McGarvey. Mr. Richard Sheibley retired as Chief of the LAP and Ms. Alger was named as the Chief of the LAP.
Ms. Alger gave an update on future pursuits for the LAP. The LAP is looking into electronic proficiency test (PT) tracking, a new database for tracking laboratory accreditation statuses, and using the Chapter 252 checklist to replace portions of the written Report of the On-site Evaluation similar to the manner in which reports are generated for NELAC laboratories. Ms. Alger and Ms. Tarquino-Morris said that the LAP will try to make the 252 checklists available before the assessments, but that they were not yet on the LAP website.
Ms. Tarquino-Morris presented the following update on compliance assistance:
1. Introduction
a. 2007 Compliance Assistance Efforts have focused on:
i. DEP developed method specific training
ii. Improvements to our website
iii. Compliance Assistance through on-site assessments
iv. General Outreach through meetings and training sessions hosted & presented by other organizations
2. Method-specific training
a. 2007 focused on BOD.
i. BOD Class developed at request of PRWA
ii. Given at 4 locations across PA
iii. Also, participated in PennTec Conference Operators’ Olympics
b. Organizations
i. Up until now, we have previously working through PAAEL, PRWA and EPWPCOA to provide our training seminars, but we will begin to present our own training in order to reach more locations and individuals
c. 2008 - Lab Ethics & Fecal Coliform
3. Website Improvements
a. Continually try to improve our website and provide new & important information in a timely manner
i. Goal for the past year has been to make website more informative & up-to-date.
ii. MUR info was up within days of the publication
b. Re-organize and make more user friendly
i. What’s New? – to easily see the most recent updates
ii. All forms and applications are now located under the heading Forms and Applications
c. Added NELAC section and Regulations section with selected ATP letters posted.
4. On-site Assessments
a. Provide compliance assistance through on-site assessments
b. First round of on-site assessments are more or less a compliance assistance visit
i. Hand out copies of regulation, Compliance Assistance documents, and 252 Technical Checklist
ii. Labs follow along with their own copy of the checklist, and we point them to the specific portions of 252 that pertain to their operation
iii. If labs don’t know how to generate a linear initial calibration curve, Department shows them step-by-step how to do it in Excel, and how Excel will calculate and display R^2 for you.
c. Labs are issued real deviations but the focus is on correct method performance, batch and method-specific QC, and getting labs used to the regulations
d. Must submit a Compliance Assistance Plan, limited supporting documentation. The laboratories must stick to their own established timelines (which Department will be checking at next on-site) and all deviations must be corrected within 120 days.
e. End with information about what to expect at next assessment and encouraged to read the checklist and regulation to find things to fix on their own before we come back. We will be looking at findings from initial on-site to ensure that deviations were corrected as was stated in their CA Plan
f. Positive feedback from on-sites
5. Outreach
a. Continue to ensure that personnel is available to attend meetings, conferences and forums
b. Again primary organizations are PAAEL, PRWA and EPWPCOA
c. Getting into Western Arena
d. Application with EPA to be withdrawn from the DMR-QA Program. PT Program under Chapter 252 will replace the EPA Program.
Summary of Laboratory Assessments
Ms. Tarquino-Morris presented the following update on Laboratory Assessments:
Summary of On-site Assessments
e. Status completed: Already have 75% of initial on-sites completed, with remainder to be finished by March 2008.
f. Major findings
i. Micro – no quality control with filtration series (sterility blanks), no biological indicators, no +/- culture controls, no sterility checks on media and equipment, don’t understand requirements
ii. Chemistry:
iii. Batch QC – not performing blanks, duplicates, Laboratory control samples or Matrix spikes as required
iv. Calibrations – not verifying with 2nd source, reporting below the lowest cal standard, not running calibration verifications, not calibrating or checking specs, or performing requirements half-way (i.e., verifying balance with 1 weight instead of 3).
v. Documentation
g. Action needed
i. Reporting Instructions for Non-potable water – cite cyanide, Micro fecal
ii. Identify sections of the regulations that need revision for content or clarity.
Ali Tarquino-Morris opened for Questions on Compliance Assistance and laboratory assessments. The following is a summary of the topics discussed during the question and answer session.
The LAP recognizes that laboratories new to the laboratory accreditation program are less familiar with laboratory regulations and the accreditation process than those laboratories that have been in the laboratory accreditation program for years through the drinking water and NELAP programs. Because the new laboratories are less familiar with laboratory regulations, the first round of on-sites for the basic non-potable water laboratories and other new laboratories was focused on compliance assistance in addition to the assessment. The report given to the basic non-potable water laboratories was abbreviated from the standard Report of an On-site Assessment given to all laboratories. Both the standard and abbreviated reports detailed assessment findings and all laboratories are given many opportunities to address the deviations in the on-site assessment report.
The assessments of new laboratories met the expectations of the LAP. Some facilities were well-prepared for the assessment and others facilities needed more explanation of the requirements and additional assistance.
The implementation of the laboratory accreditation program focused on integrating the new laboratories into the program. The commercial laboratories that had been in the LAP before promulgation of the 252 regulations have been pushed back from their typical on-site schedule approximately six months in order to complete the assessments of the newly applied laboratories. During the second round of on-sites, the LAP will attempt to stagger the schedules of all laboratories into the expected two year schedule. In order to do this the LAP may perform the second on-site within one year of the initial on-sites.
The number of laboratories that applied for accreditation is significantly lower than expected. The LAP expected 1000 laboratories, and approximately 600 applied for accreditation.
The general feedback with regard to the initial assessments has been positive.
Compliance assistance training has been given to regions throughout the state. The LAP generally teams up with existing organizations to offer training presentations, but the future plans are to offer training sponsored by the LAP in addition to those organizations, possibly held in the different regions.
The Department is working with the EPA in order to eliminate the requirement of PA facilities to participate in the DMR-QA program. The EPA has evaluated the LAP and the Chapter 252 regulations. The LAP is waiting for the final word from the EPA regarding the DMR-QA.
Current accreditation fees do not adequately cover the actual costs of travel and administration. The LAP may change the category structure of the fees to correct some of the flaws in the current fee category structure. The intent is to make minor changes to the current fee structure.
Chapter 252 Discussion
The committee discussed the current Chapter 252 regulation and agreed that several changes should be made during the next revision. Ms. Alger informed the committee that the LAP was in the process of requesting permission to begin the regulation development process. This request would need to be made directly to the Secretary. When the approval is granted, the membership would be notified, and the amendment process would begin.
Other Business and Adjourn
Mr. Morse adjourned the meeting.
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