Laboratory Accreditation Advisory Committee (LAAC)
Minutes of June 1, 2005
Call to Order, Attendance, Introductions, Welcome:
The eleventh 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
10:05 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:
Daniel Donnelly
David Barrett
Donna Wingle (for Anita Martin)
Edward Chun
J. Wilson Hershey
John Hood
Kathy Maylath
Stephanie Olexa
Stephen Morse
Duquesne University
Mahaffey Laboratory LTD
Lehigh County Authority
General Public Member
Lancaster Laboratories, Inc.
PA Rural Water Association
PPL System Chemical Laboratory
Benchmark Analytics
Skelly & Loy, Inc.
Department of Environmental Protection (DEP) attendees:
Richard Sheibley
Scott Perry
Aaren Shaffer
Jerry Winski
Lisa Daniels
Bethany Piper
Ron Houck
Chief, Laboratory Accreditation Program
Bureau of Regulatory Counsel
Laboratory Accreditation Program
Laboratory Accreditation Program
Bureau of Water Supply and Wastewater Management
Laboratory Accreditation Program
Laboratory Accreditation Program
Trevor K. Brenner
Joe Lapcevic
Tracy Siglin
Steve Neidlinger
M.J. Reider Associates
Allegheny Energy
Exelon Generation
PCIC-PA Chemical Industry Council
Guests:
Approval of Minutes:
Mr. Donnelly moved to approve the minutes from the April 14, 2005 meeting. Mr.
Morse seconded the motion. The motion passed unanimously. Ms. Wingle requested that the
minutes reflect the affiliations of the committee members.
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Comment and Response Document Review:
The "Comment and Response" document summarizes each comment submitted to the
Department. This document groups each comment by topic. Each commentator was assigned a
number and the numbers after the comments designate the commentator(s) responsible for each
comment. Some of the comments have multiple numbers associated with them. The Committee
went through the document by topic.
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General Comments- none
Chapter Organization- none
Composition of Advisory Committee- none
Scope- none
Definitions- none
Interim Accreditation and Time of Application for Accreditation- Ms. Maylath asked what
the procedure would be for a laboratory that starts business after the initial 6-month interim
accreditation period. Mr. Sheibley explained that the procedure for accreditation would be
the same as it is now in the State Drinking Water Accreditation Program. The laboratory
would have to apply for accreditation, and then participate in an on-site evaluation and
proficiency test (PT) studies, etc. Accreditation would be granted when the on-site was
successfully completed and all other requirements met by the laboratory. Mr. Sheibley
reminded the Committee and guests that interim accreditation would not be granted to
laboratories until their application for accreditation is complete. This includes the
application, payment of fees and a supervisor that meets the necessary requirements. The
Department predicts that approximately 700 laboratories will need accreditation. Mr.
Sheibley also stated that there is no advantage to laboratories to wait to apply at five months
and 29 days. The on-site schedule will not be determined based on the date of application.
The geographical location will play heavily into the on-site schedule.
Accreditation by Rule- none
Mobile Laboratories- Mr. Morse asked if a “mobile” laboratory owned by another accredited
laboratory would require separate accreditation, even if the mobile laboratory only performed
portable GC-MS analysis. Mr. Sheibley stated that yes all mobile laboratories require
accreditation. This requirement is regardless of type of testing or size of laboratory.
Fees- The committee decided to discuss this topic after lunch.
Out-of-State Laboratories- none
Laboratory Supervisor- Ms. Wingle asked why a grandfathered laboratory supervisor would
not be permitted to transfer to another laboratory and keep the grandfathered status. Mr.
Sheibley explained that the grandparent provision is not portable since should a person
transfer to another facility, the testing methodology and instrumentation and plant operation
would most likely be different. The reason for the grandparent provision is to assure that no
one looses his or her job because of this regulation. Mr. Sheibley also explained that this is
the same provision as written in the Chapter 109 Drinking Water program.
Personnel Requirements and Training- none
Equipment- none
Methodology- none
Records and Recordkeeping- none
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Work Cells- none
Chemistry, Toxicity, Microbiology, and Radiochemistry Quality Control Requirements- none
Proficiency Testing- none
Miscellaneous Provisions- none
Coordination with Other Regulations- Mr. Sheibley explained that Chapters 78 and 109
required changes to comply with the specifications outlined in Chapter 252. Dr. Olexa asked
about the reporting requirements listed in Chapter 109. The Drinking Water Program
requires specific notification and forms, but this does not address Non-Potable Water and
Solid and Chemical Materials. Mr. Sheibley explained that Chapter 109 is specific to
Drinking Water and that Chapter 252 specifies laboratories must follow the reporting
procedures of the specific programs.
Draft Regulation Review
Mr. Sheibley explained the format of the new Chapter 252 Draft Regulation. This format
includes the new, changed, and deleted text. The new and changed text is identified in all
capitals and the deleted text is identified by single strike-through.
§252.1 Dr. Hershey asked why “internal standard” was not defined. Mr. Sheibley explained that
terms used in their plain meaning do not require definitions.
§252.5 Dr. Hershey asked if laboratories requesting NELAP accreditation for Air would need to
apply to an accrediting authority other than PA. Mr. Sheibley stated that Chapter 252 does not
limit laboratories to the testing listed on their scope of accreditation, only to those parameters for
which PA requires accreditation. Should a laboratory want to perform Air testing on PA
samples, PA has no required accreditation. A laboratory may choose to obtain accreditation for
Air parameters from another state or NELAC accreditation program.
§252.6(a)(1) Mr. Sheibley explained that this statement only requires laboratories to perform
analysis according to the specific permit or program regulation. If none exists, the laboratory
may determine which method it uses.
§252.204 Dr. Hershey asked Mr. Sheibley to explain the category “Application Fee—Addition
of Fields of Accreditation.” Mr. Sheibley explained that laboratories must pay this fee any time
they wish to make a change to their Scope of Accreditation other than the initial application or
renewal application. This would be a mid-year accreditation change.
Dr. Hershey asked for explanation of the Drinking Water and Non-Potable Water
combined category. Mr. Sheibley explained that the combination of the two matrices occurred
because many of the methods overlap. Many laboratories do not distinguish the analysis of
Drinking Water and Non-Potable Water, using the same instrumentation and personnel.
Therefore, it is not double the effort to perform an on-site for a laboratory performing both
Drinking Water and Non-Potable Water.
Dr. Hershey asked if there are any laboratories adversely affected by the change in fee
structure. The Department expects that the fees assessed to the laboratories would be relatively
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the same regardless of the structure. The benefit of the new structure would be that the labs
would have an easier time determining the required fee for the desired accreditation. Dr.
Hershey asked if the NELAP fee structure is the same as that listed in Chapter 252. Mr. Sheibley
answered yes.
Ms. Wingle asked if laboratories would need to re-apply when the regulations become
effective. Mr. Perry answered yes.
§252.207 Dr. Hershey asked what would happen to laboratories if the Department cannot assess
everyone within one year. Mr. Sheibley stated that interim accreditation could go on
indefinitely.
§§252.304(b)(4) & (b)(8) Deletion of these two paragraphs occurred because other sections of
Chapter 252 stipulate that the laboratory supervisor is responsible to retain all records required
by this chapter. These paragraphs are not necessary.
§252.501(k) Dr. Hershey stated that this section reads like a laboratory could lose more than one
analyte. Mr. Sheibley answered that field of accreditation is a defined term.
§252.701(2) Ms. Daniels asked if since “selectively reporting data” was taken out of Chapter
252, should it now be defined in Chapter 109? Mr. Sheibley explained that he thought that the
term does not require further definition. Mr. Sheibley added that §§252.702 (b)(8), (9), and (10)
effectively define “selectively reporting data.” Dr. Olexa asked if wastewater reporting should
be defined. Mr. Sheibley explained that wastewater has its own reporting rules that must be
followed and do not need to be included in Chapter 252.
§252.706 Mr. Sheibley explained that the additions to this section include the specific
requirement that all original observations, including handwritten data, must be retained by the
laboratory.
§252.708 Dr. Olexa commented that the changes in this section are very good. The previous
drafts would have made the notification requirements burdensome to laboratories.
Consumer Price Index
The Committee discussed the Department’s use of the Consumer Price Index (CPI) to
determine the change in fees. Mr. Sheibley explained that the initial set of fees were determined
based on the cost of the current State Drinking Water program, including personnel costs,
implementation of database technology, and other factors. These fees do not account for
expansion of the program past Non-Potable Water and Solid and Chemical Materials. Should
the Department wish to expand the Laboratory Accreditation Program to other areas, such as Air,
the Department would need to write a new regulation package.
The Committee showed concern that the CPI would not accurately account for the true
costs to run the program. Several of the Committee members believed that the CPI is not a bad
idea. By using the CPI to adjust fees, the change in fees would be limited and easier than a
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regulation change every time the program costs increased above the current fee structure. Other
Committee members believe that the CPI is not an accurate way to determine the cost of the
program, and the only acceptable way to assess the costs of the program on a regular basis and
adjust the fees would be through a formal regulation change.
Recommendations and Motions:
The committee agreed to support the Chapter 252 Regulation as written. Mr. Morse
moved that the chair write a letter to the EQB indicating support of the submission of the draft
regulations and the changes to Chapters 78 and 109 be approved as final rulemaking. Mr. Barrett
seconded the motion. The motion passed with a vote of eight in favor and zero opposed.
Meeting Schedule and Adjournment:
The Committee decided to adjust the time of the next meeting to coincide with the next
PA Accredited Environmental Laboratory meeting. This meeting will be held on November 1,
2005 at the new Bureau of Laboratories Building at 10:00 a.m.
Dr. Hershey also commended the Department on the time and effort put into the Chapter
252 Regulation. He thanked Mr. Sheibley and his staff for all the work they did. Dr. Hershey
adjourned the meeting by thanking the committee members and guests for their continued help
with the draft regulations.
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