Laboratory Accreditation Advisory Committee (LAAC) Minutes of April 13, 2004

Call to Order, Attendance, Introductions, Welcome:

The tenth 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 9:03 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:

David Barrett Dave Muzzy (for John Hood) Daniel Donnelly Stephen Morse J. Wilson Hershey (Chair) Stephanie Olexa Anita Martin Fred Taylor Kathleen Maylath

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 Michelle Rossi, Laboratory Accreditation Program Dwayne Burkholder, Laboratory Accreditation Program Carmen LaRosa, Laboratory Accreditation Program Bob Titler, Laboratory Accreditation Program Julia Anastasio, Policy Office Lisa Daniels, Water Supply and Wastewater Management

Guests: Trevor K. Brenner, M.J. Reider Associates Gregg Gnipp, ARIPPA Donna Wingle, Lehigh County Authority David Piller, Exelon Power Erik Ross, NAWC Mike Farlling, Analytical Laboratory Services Richard Stump, Suburban Water Testing Labs, Inc. Douglas Kester, Merck and Co., Inc.

Page 1 of 9 Approval of Minutes:

Mr. Morse moved to approve the minutes from the joint LAAC and Certification Program Advisory Committee meeting from January 23, 2004. Dr. Olexa seconded the motion. The motion passed unanimously.

Dr. Donnelly moved to approve the minutes from the February 10, 2004 meeting. Mr. Barrett seconded the motion. The motion passed unanimously.

Committee News:

Mr. Sheibley announced that the term limits for the committee members conclude in August. He encouraged any committee member or member of the audience to notify him of interest in the positions that are available for the next term. Dr. Donnelly asked what the ongoing role of the committee would be after adoption of the regulations. Mr. Sheibley stated that approval and help with the many necessary guidance documents would be the major focus of the committee in the coming months and years. He also added that the committee would be asked to help with advice to the accreditation program. The frequency of the meetings will probably not be every other month as they have been, but will be the required four times per year.

Draft Regulation Review:

Mr. Sheibley began with a brief overview of the thoughts behind the changes from the last draft of the Chapter 252 regulations. The Department seriously considered comments from every concerned party. These concerns came from the LAAC committee, PA Municipal Authorities Association (PMAA), PA Water Environment Association (PWEA), Certification Program Advisory Committee (CPAC), and many other individuals and groups.. The changes made in the draft regulations are only those that assure good quality data. The committee’s end goal is to have a final draft of the regulations that they recommend or indicate support to the Environmental Quality Board (EQB).

The committee worked through the “Major Change Summary” document with some additional comments to other sections. (All references refer to the March 19, 2004 Draft Regulations)

§252 various: No comments.

§252.1 definitions: The committee began the discussion with suggestions of several additional definitions. The suggestions were the addition of continuing calibration verification, discharge, process control, Public Water Supplier, and statistically indistinguishable. The committee agreed to add continuing calibration verification. Mr. Sheibley and Mr. Perry explained that words not used in the draft regulations did not require definition, such as discharge and process control. The committee decided that since use of Public Water Supplier occurs as a heading, it does not require a definition. Mr. Sheibley said that statistically indistinguishable will be clarified in guidance documents from the Department.

Page 2 of 9 §§252.3(c)(3) and (4): No comments.

§252.5(d): Dr. Hershey asked if NELAC accredited laboratories can apply and obtain State accreditation for parameters not offered by the NELAC program. Mr. Sheibley stated that NELAC laboratories would have the option of PA State accreditation for those parameters not offered by PA NELAP accreditation. He went on to say that it is easier to add parameters to the PA State scope of accreditation than it is to add to the PA NELAP scope.

§252.6(a)(1): Mr. Sheibley explained that this change was made to clarify that when promulgated methods are required, they must be used. For instance, drinking water tests must use methods approved in 40 CFR, Parts 141 and 143, and wastewater tests must use methods approved in 40 CFR, Part 136.

§252.6(b): Mr. Barrett asked how the Department would find out about inappropriate activity? Mr. Sheibley clarified that the Department will investigate complaints from citizens, regional offices, and other laboratories.

§§252.6(d) and (e): Addition of these paragraphs occurred after meetings with other groups that wanted process control clearly defined. This clarifies that if the Department does not require the test, it is not covered by this Act. Therefore, if the laboratory chooses to perform additional testing not required by their permit, then those tests are not under these regulations. Mr. Morse asked about site characterization testing and whether this is covered by the Act. Mr. Perry explained that there is a difference between the screening to determine if testing is required and the tests used to determine compliance. The Act does not cover the first situation. Some of the committee members thought this might confuse some of the laboratories with regard to reporting requirements. Mr. Sheibley reminded the committee that the permit specifies the reporting requirements. The draft regulations do not specify how, when and what to test and to report. They specify the requirements necessary when testing for complicance.. Mr. Sheibley also suggested the committee wait until the formal public comment period to see what comments are submitted.

§252.6(f): Mr. Sheibley commented that no accreditation-by-rule parameters were taken out, but several had been added.

§252.6(g): Ms. Daniels commented that with the addition of this paragraph, the regulations do not tell accreditation-by-rule laboratories how to report results. Mr. Sheibley stated that other regulations require and specify reporting instructions, and this concern is covered by §252.6(a) (3). For example, Chapter 109 requires and specifies the reporting requirements for the drinking water program. However, the Department will add some wording to make this clear.

§252.202(a): No comments.

§252.204(a): Changes to this section in the draft regulations occurred according to Departmental requirements. The “Directly Linking Fee Increase to Consumer Price Index” concept paper reflects the changes. The changes to the fees will occur in accordance with the Consumer Price

Page 3 of 9 Index (CPI). These changes will occur approximately every three years and the first change will depend on the CPI on June 30 of 2008. The Department will use that figure to calculate the fees for the year beginning January 1, 2009. The Department plans to have the fees posted by September of the year before the rate change. This allows time for budget planning for the laboratories.

Members of the committee and audience were concerned that many Pennsylvania labs will max out the categories. Dr. Olexa commented that she believed her laboratory would end up paying about $26,000 every two years, and she was concerned that this is a large amount of money for one on-site evaluation. Mr. Sheibley explained that the annual fees pay for more than a bi-annual on-site evaluation. These fees cover the cost of travel to the laboratories, subsistence and lodging, printing of certificates, tracking PTs, processing applications, etc.

Dr. Olexa also asked about small laboratories that may not have a large sample intake, but want to offer full service to their clients. She clarified that the cost of certification for those laboratories will be very high. Ms. Anastasio reminded the committee that the fees paid to the Department must cover the cost of the program. The number of samples analyzed by the laboratory does not affect the cost of an on-site evaluation. The Department will also develop a list of equivalent methods for which one method fee will be charged for several methods with the same procedure but different method numbers. The best example of this consolidation can be demonstrated using the example of metals methods. For instance, one method fee for all graphite furnace methods by Standard Methods and EPA Methods will be charged rather than an individual method fee for each separate method number. The Department feels there is enough difference between the wastewater, drinking water, and SW-846 methods that these will be classified as different methods. The certificates will list the specific method for which the laboratory is certified. Mr. Sheibley added that the fees listed in the concept paper were applied to several PA laboratories as a “reality check,” with NELAC and State accreditations, and no laboratory reached the maximum in any category. The average cost for large labs was in the $7,000-8,000/year range.

Mr. Farlling asked if PA NELAC laboratories could seek primary accreditation from another accrediting authority to pay lower fees. Mr. Sheibley stated that NELAC requires the laboratory first seek primary accreditation in their home state. Only if it is unavailable, may the laboratory apply for primary NELAP accreditation in another state. Mr. Sheibley reminded the committee and audience that all laboratories analyzing samples for PA compliance purposes must attain PA accreditation. This accreditation requires payment of the fees.

Ms. Maylath asked what the $700 application fee covers, stating that this is much higher than the NELAC fees. Mr. Sheibley explained that the NELAC fees and the State fees are the same. The fees listed in the NELAC guidance document titled “Procedures for the Approval and Accreditation of Laboratories in the Commonwealth of PA Utilizing NELAC Standards” are interim fees for the NELAC program until approval of the Chapter 252 regulations.

Ms. Maylath also stated that hardness is an accreditation-by-rule parameter, but it is listed in the basic drinking water category. Mr. Sheibley agreed to take it out since it is not a compliance parameter required by the drinking water program. He reminded the committee that

Page 4 of 9 removing the accreditation-by-rule parameters from the basic drinking water and wastewater categories means that a laboratory that wants any of these parameters for accreditation would have to pay an additional fee to get them.

Ms. Daniels suggested addition of fecal coliform to the basic drinking water category. Mr. Sheibley agreed.

§252.206(c): No comments.

§252.301(f): No comments.

§252.302(h): Changes made in this section of the draft regulations reflect the changes in the Chapter 303 operator certification regulations. The first change removed the experience requirement for the laboratory supervisor. The operator certification requirement for this sub- classification module requires two years of experience, therefore, making it redundant to list it in Chapter 252 as well. This also allows for a transition period if the operator certification program does not offer a laboratory supervisor sub-classification.

§252.303(c): This addition allows a grandparented supervisor to continue to be the laboratory supervisor for the laboratory if the scope of the permit changes. Mr. Muzzy asked if a grandparented laboratory supervisor could move to another laboratory and continue to be grandparented. Dr. Donnelly stated that he thought the previous draft regulations contained specific wording saying the grandparent provision was non-transferable. Mr. Sheibley answered both questions, “No.”

§252.304(b): No comments.

§§252.306(f)(1)(ii) and (3)(i): This change reflects the requirements listed in the NELAC Standard. Dr. Hershey indicated changes to the weight title “Class S.” Mr. Sheibley clarified that that is why designations of ASTM type 1, 2, or 3 are also included.

§252.401(g)(4): This paragraph was changed because some holding times are specified in regulations, and they are not always the same as the method. The laboratories must follow the specific regulations, and if nothing is required, then refer to the method to determine sample holding times.

§§§§252.402(a), 403(a), 404(a), and 405(a): This paragraph specifies that when determining which requirement to follow, the method or Chapter 252, the more stringent requirement must be followed unless otherwise specified.

§252.402(c)(2): No comments.

§252.402(c)(5): Dr. Hershey asked if the LCS is a second source from the calibration standards would it cover the requirements of this paragraph? Mr. Sheibley clarified that the same sample/standard could meet multiple requirements as long as the laboratory applies the most stringent rule to the sample/standard.

Page 5 of 9 §252.402(d)(1)(iii): Dr. Hershey asked why the requirement is 0.999 for a non-linear calibration curve, saying that he thought the committee had agreed to change it to 0.995. Mr. Barrett stated that the committee recommended to drop the last 5 in each of the calibration curve correlation coefficient requirements, thus, reducing the minimum acceptability from 0.995 and 0.9995 to 0.99 and 0.999 for linear and non-linear curves respectively.

§252.402(e)(3): The Department will develop guidance for these procedures. Laboratories may choose to use these Department guidelines instead of developing their own acceptance criteria. Laboratories may develop their own acceptance criteria if they so choose. However, laboratory developed acceptance criteria must be legally defensible.

§252.402(f)(3): Dr. Hershey commented that the requirement for variation of the calibration verification concentration is no longer a NELAC requirement. Mr. Sheibley stated that this is one instance where the Department disagrees with NELAC, and it will continue to strongly suggest that NELAC laboratories continue to vary the concentrations of the calibration verifications. Dr. Olexa commented that analysis of a high-concentration calibration verification standard for single point calibration instruments such as metals would be a problem. She stated that analysis of standards at the high level would contribute carry-over to the next samples. Mr. Sheibley asked what the laboratory procedure is if the samples analyzed have carryover. Dr. Olexa said that dilution of samples usually occurs before analysis. Mr. Brenner asked if analysis of rinse blanks occurs after calibration to minimize the carryover after analysis of the high calibration standard, because laboratories must calibrate at the highest quantitation level. Mr. Sheibley then clarified that the calibration verification requirement is to analyze the high- concentration standard within the upper 20% of the calibration curve, not the upper 20% of the linear range of the instrument. Instrument calibration should occur in the range where minimal or no carryover occurs.

§252.402(f)(8): Ms. Daniels asked the purpose of reporting data with qualifiers. Mr. Sheibley explained that the drinking water program is the only program that does not accept qualified data. Many times, it is more valuable to receive qualified data rather than no data at all. In some instances, a re-collected sample would not give the desired information. For instance, the data user may need information from a specific site at a specific time; re-collection would not provide this information. Other data users require results below the calibrated range. This data would be between the MDL and the reporting limit. This data is qualified because it is less certain.

Mr. Piller asked about instances where use of qualified data occurs for compliance purposes, and it is truly bad data. Mr. Sheibley explained that these draft regulations are to assure accurately reported data, and the Department will need to develop procedures to assure proper evaluation of the data.

Ms. Daniels suggested the committee categorize the data qualifiers, such as interference versus calibration, so the data user will be able to accurately determine whether another sample would yield better data. She suggested compiling a list of traditionally “poor performers” based on information from the Bureau of Laboratories.

Page 6 of 9 Dr. Hershey asked if this paragraph contradicts §252.402(f)(1) with regard to analysis of calibration verification standards when using internal standards. Mr. Sheibley said, “No.”

Mr. Brenner asked if §402(f)(8)(ii) is correct when it says these “results may be reported with appropriate data qualifiers.” Mr. Sheibley answered that the data user must know that the sample results are not within the acceptance criteria, but that the results are at least that high.

§252.402(i)(1): Dr. Olexa asked why matrix spikes are not required, but matrix spike duplicates are an option. Mr. Sheibley stated that the general move is away from the requirement of matrix spikes, but the regulations offer the option to analyze a matrix spike duplicate instead of a sample duplicate because some methods require analysis of matrix spikes.

§252.402(l): No comments.

§252.403: No comments.

§252.404(c)(1)(i): No comments.

§252.404(d)(3): A member of the audience commented that (i) is a very strict requirement, stating that (ii) is usually the requirement for most drinking waters. Mr. Burkholder explained that the requirements in this section are those specified by the EPA for microbiology.

§252.405: No comments.

§252.501: Mr. Sheibley explained deletion of the requirement for successful analysis of two out of the most recent PT studies. However, the laboratory may not retain accreditation for parameters that have two failed PT studies in a row. This provision is specified in the section listing the reasons for suspension §252.705(b)(3).

§252.501(c): No comments.

§252.501(d): Mr. Barrett asked what would happen to a laboratory should the PT provider invalidate a study or fail to ship the study within the required amount of time. He explained that in these situations the laboratory might not have a valid PT study within the required 12-month period, but at no fault of the laboratory. Mr. Sheibley indicated that the Department might use regulatory discretion and allow the laboratory to participate in the next available study without penalty. Both Dr. Hershey and Dr. Olexa stated concern that the newly regulated laboratories may not understand that waiting exactly 12 months between PT studies would result in loss of accreditation should the laboratory fail one or more parameters in that study. They suggested that the “at least once every 12-month” requirement may be restrictive and the Department should allow leeway or a window for make-up PT studies. Dr. Hershey suggested a system similar to vehicle registration. Dr. Olexa suggested allowing analysis of a PT every calendar year but no closer than 60 days. A member of the audience suggested a program similar to the FAA, requiring a PT by the end of the month or within 30 days of the study closing date from the previous 12-month period. Mr. Sheibley stated that he would be very uncomfortable with allowing laboratories to wait longer than 12 months between successful analyses of PTs. Mr.

Page 7 of 9 Perry clarified that should a laboratory choose to analyze PTs every 9 months in order to allow time for a make-up PT, the laboratory would actually only end up analyzing one extra PT every three years. Mr. Sheibley reminded the committee that the real question is, “What is an appropriate requirement for the laboratory?” If 12 months is appropriate, then this rule is appropriate. The committee voted and unanimously decided that the every 12 months rule is reasonable. Dr. Hershey stated that he would like to see a warning to laboratories cautioning them of the consequences should they wait until the twelfth month to analyze PTs.

Mr. Brenner asked if quick response PTs are acceptable. Mr. Sheibley stated that currently they are accepted, but EPA is reviewing its policy, and may deem them unacceptable.

Ms. Maylath asked about the effective date for loss of certification due to PT failure. Mr. Sheibley explained that the effective date for loss of accreditation is the date of the letter from the Department notifying the laboratory of the change of accreditation status. The loss of accreditation is not retroactive to the closing date of the study.

§252.501(h): Dr. Hershey suggested adding wording to make this paragraph say, “knowingly receive.” Mr. Sheibley agreed.

§252.601(d): Dr. Olexa commented that this paragraph does not specify a time line for the Department to supply an on-site report to the laboratory. Mr. Perry explained that this was intentional, and the question is, “What happens if the Department does not follow its own rules? Does the laboratory suffer consequences?” Mr. Sheibley reminded the committee that the clock specified in (e), (f), and (g) does not begin until the laboratory receives the on-site report.

§252.601(h): Dr. Hershey asked if this was an exhaustive list or just some examples. Mr. Sheibley stated that these are the only reasons the Department may grant an extension.

§252.703(d): Mr. Sheibley explained the addition of the statement “affected by the revocation.” The laboratory does not need to notify unaffected customers.

§252.704(b)(3): No comments.

§252.706(a)(1): Dr. Hershey asked if the requirement is to really display the accreditation certificate and fields of testing, or if it is acceptable to make them available to the clients. Mr. Sheibley agreed to change the requirement to “make available.”

§252.708(a): Dr. Olexa asked if this section meant that a State accredited laboratory could not sub-contract samples to a NELAC accredited laboratory. Mr. Sheibley clarified that both PA accredited NELAC laboratories and State laboratories are considered equivalently accredited under Chapter 252.

§252.709(b): Ms. Wingle asked what “in writing” meant specifically. Can a laboratory notify the Department by e-mail, or must it be hard copy? Mr. Sheibley explained that the laboratory must use traditional mailing procedures to notify the Department.

Page 8 of 9 §§252.709(b) and (d): Dr. Hershey was concerned that the laboratory may not know of every structural change regarding wiring, plumbing, etc. 30 days in advance. Dr. Olexa was concerned that minor cross training of analysts would constitute a change in assignment, and make it almost impossible to keep the Department up-to-date on all laboratory changes. Mr. Sheibley explained that the Department uses the knowledge of personnel changes to determine possible problems. Loss of personnel may indicate inability to perform the tests, while substantial turnover is a red flag to potential analytical problems. The committee suggested removing §§709(d) and (e) and allowing §252.709(b) to cover the section. Mr. Sheibley agreed.

Recommendations and Motions:

The committee agreed that pending the changes suggested and agreed to by the Department at this meeting, they would recommend the draft regulations go to the EQB. Mr. Morse moved that the chair write a letter to the EQB indicating support of the submission of the draft regulations as proposed regulations pending changes suggested at this meeting. Dr. Olexa seconded the motion. The motion passed unanimously.

Meeting Schedule and Adjournment:

Mr. Barrett informed the Committee that the next Pennsylvania Association of Accredited Environmental Laboratories (PaAAEL) meeting conflicts with the next LAAC meeting on June 8, 2004. The committee discussed possible dates for rescheduling the meeting. The next meeting is tentatively scheduled for June 2, 2004 at 10:00 a.m.

Dr. Hershey thanked the committee members and guests for their continued help with the draft regulations. He adjourned the meeting at 2:42 p.m.

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