Laboratory Accreditation Advisory Committee (LAAC)

Laboratory Accreditation Advisory Committee (LAAC) Minutes of September 29, 2008

Call to Order and Attendance

The September 29, 2008 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 10:05 A.M. Vice Chair Daniel Donnelly 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 Danielle Cappellini A E Kirby Memorial Health Center Daniel Donnelly Duquesne University David Barrett Mahaffey Laboratory LTD Stephen Morse, P.E. Skelly and Loy, Inc. Gene Greco Western PA Water Pollution Control Association Marykay Steinman Analytical Quality Assistance Richard Eakin Analytical Testing Services, Inc.

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 Bethany Piper Laboratory Accreditation Program Virginia Hunsberger Laboratory Accreditation Program Clare McCarthy Laboratory Accreditation Program

Guests:

Tom Jageman US Steel – Clairton Tracy J. Siglin Exelon Generation Co Bernard Spada ALCOSAN Frank Medora Aqua Pennsylvania, Inc.

Review and Approval of Minutes

Mr. Stephen Morse made a motion to approve the minutes from the October 16, 2007 meeting. Mr. Gene Greco seconded the motion. The motion passed unanimously.

Discussion of 252 Second Draft Regulations

The committee began discussion of the draft chapter 252 regulations. The committee discussed the revisions in a section-by-section fashion. The first draft revisions are identified in purple and the second draft revisions are identified in red in the second draft regulations version 08/07/2008.

Subchapter A. General Provisions

§ 252.4. General Requirements No comments.

§ 252.5. NELAP/TNI equivalency No comments.

Subchapter B. Application, Fees and Supporting Documents

of 9 Laboratory Accreditation Advisory Committee (LAAC) Minutes of September 29, 2008

§ 252.204. Fees

Ms. Martin asked “If you renew your application and add a new field of accreditation, do you pay the addition of fields of accreditation fee?” Ms. Alger answered that a laboratory does not have to pay the addition of fields of accreditation fee if a new field of accreditation is added during the application renewal. A laboratory may have to pay the supplemental on-site assessment fee if an on-site assessment is required for the new field of accreditation.

§ 252.205. Out-of-State laboratories

No comments.

Subchapter C. General Standards for Accreditation

§ 252.301(a). Laboratory Supervisor

Ms. Alger explained that the requirement in § 252.301(a) was a clarification of Department policy. If a person is the supervisor of the laboratory, then that supervisor must be listed on the application. The committee did not have any comments.

§ 252.302(d). Qualifications of the laboratory supervisor

Dr. Donnelly explained that the change in § 252.302(d) changed the requirement for four credits in general microbiology to four credits in biology for a microbiology supervisor of a microbiology laboratory with testing limited to fecal coliform, total coliform, and heterotrophic bacteria.

§ 252.304(b)(3)(vi). Personnel Requirements

Ms. Alger explained that the requirements for the initial demonstration of capability are the same as in the current regulation, but that the section was moved for consistency in organization. Dr. Donnelly commented that in § 252.304(b)(3)(vi)(G) the work cell requirements may be difficult if the work cell is large. Ms. Alger explained that the entire work cell is not required to repeat the initial demonstration if one person changes. Only the affected portions of the work cell need to be performed, such as a percentage of the work cell. Ms. Steinman added that work cells are not required in laboratories.

§ 252.306. Equipment, supplies and reference materials

§ 252.306(f)(2)

Mr. Barrett asked if the change in § 252.306(f)(2)(iv) was changed based on the comments from the July 9, 2008 meeting. Ms. Alger explained that the changes were based on the comments from the previous meeting. The section was changed from requiring working thermometers to be within 2C from the most recent calibration to be within 2C from the reference thermometer.

§ 252.306(f)(3) No comments.

§ 252.306(f)(4)

Dr. Donnelly explained that the term notebook was removed to eliminate confusion in the requirements for record keeping in § 252.306(f)(4)(v). Ms. Cappellini asked why the requirement for the documentation of correction factors was removed. Ms. Alger explained that the requirement was removed because the Department did not know how to implement the correction factor for balances and did not know how to enforce the requirement. The statement was difficult to enforce.

§ 252.306(f)(8)

No comments.

§ 252.306(f)(9) No comments.

§ 252.306(f)(10) No comments.

§ 252.306(h)(2)

Mr. Jageman explained that he has a difficulty with the requirement In § 252.306(h)(2) which requires records for standard, reagent and supply receipt records and the date supplies and reagents are consumed or discarded. Mr. Jageman explained that he doesn’t see this requirement as an effective tool. It may be expensive to keep the increased records. Mr. Jageman used the example that tracking of oil and grease disks to match up with the analysis would be difficult. Mr. Jageman added that a laboratory caught falsifying analysis by not using supplies for the analysis is unique, and he felt that to punish all for one lab’s mistake is unnecessary. Mr. Jageman explained that he wouldn’t expect this tool to catch labs falsifying analyses.

Ms. Alger responded to Mr. Jageman’s comments and stated that the laboratory’s offense was one reason for the requirement. Another reason for supply tracking is to track for recalls, or if equipment has an effect on results. This requirement has always been required for microbiology, but the Department wanted to add the requirement for all laboratories.

Mr. Jageman said that you may want to go back and track per lot, but wouldn’t the quality control (QC) in the batch also indicate problems. If QC is acceptable, then why should a laboratory reject data if equipment is wrong and the QC is acceptable? Manufacturer recalls may not have affected results but would require data rejection. Do a lot of potentially suspect supplies really affect results?

Ms. Cappellini explained that this information is already identified on packing slips and materials, adding it to a log not difficult. Certificates of Analysis (COAs) just indicate the purity of materials, and are not always required. Ms. Alger added that a laboratory is not required to obtain additional information if it is not available from the supplier. The Department did not intend to require COAs for all materials and supplies, but did intend to just require laboratories to retain COAs that were provided by the supplier or available. Laboratories are not required to obtain COAs for all materials and supplies.

Mr. Jageman asked the Department to clarify the language of the COA requirement in the regulation to prevent the requirement for laboratories to retain COAs for all materials.

Mr. Jageman stated that tracking when materials are consumed is a difficult requirement to perform. His laboratory purchases large volumes of supplies and distributes them outside of the laboratory to other areas of his facility. He explained that it would be difficult to track materials when they leave the laboratory. Ms. Alger explained that the Department was not looking for tracking that was that extensive. Mr. Jageman said that if an assessor looks at a supply log, the assessor may have difficulty if “lot A” of a material is still in use in the laboratory.

Ms. Steinman added that the requirement for supply tracking was part of the problem with the requirement. Ms. Alger explained that the requirement came from the microbiology requirements. Tracking of supplies is important for filters because filter sterility is important per lot.

Ms. Cappellini said that the Department should remove the requirement for the date consumed or discarded. The standards record requirements would be the same. Dr. Donnelly asked the committee if they wanted the date discarded removed from the draft regulation. Ms. Martin added that clarification for the COA requirement was needed. Ms. Alger asked if the language “if provided or available” for COAs would be acceptable to add to the COA retention requirement.

§ 252.306(h)(4)

Ms. Steinman noted that the letter “t” was missing in § 252.306(h)(4) in the word “pas”. The word should be “past”. Ms. Cappellini asked if the revalidation procedure for reagents and standards that are past their expiration date would have to wait until the department develops a procedure for the revalidation. Ms. Alger explained that the Department would not prevent laboratories from revalidating their standards if the Department hasn’t developed a written procedure.

§ 252.307(d). Methodology

Mr. Jageman explained that the requirement of MCLs and action limits to be identified in SOPS in § 252.307(d) is excessive, because action limits and MCLs change frequently.

Mr. Eakin asked if the information in § 252.307(d)(1)(iii) could be referenced in the SOP to a separate document. Ms. Alger explained that the reference to another document was acceptable. The intention of the requirement was with regard to drinking water, where MCLs and action limits change infrequently. The term action limit was added for lead and copper. Ms. Alger explained that the Department may clarify this section to reflect the requirement for drinking water.

Ms Martin commented that there was no definition for action limit in § 252.1. Dr. Donnelly asked the committee if they felt that adding a definition for action limit would help? Ms. Alger stated that the intent was for the SOP to provide a number to indicate when something would be flagged. The requirement could be clarified by rewording the statement to “and MCL(s) or action limits for drinking water as appropriate”.

Subchapter D. Quality Assurance and Quality Control Requirements

§ 252.401. Basic Requirements

§ 252.401(a)(3) The word “effective” is spelled wrong.

§ 252.401(b) No comments.

§ 252.401(d)

Dr. Donnelly explained that timelines for ethics training were added to this section. The committee did not have any comments.

§ 252.401(f).

Ms. Alger explained that initially the language in this section was confusing. With Mr. Perry’s assistance, the Department clarified the minimum criteria for tracking samples. The committee did not have any comments.

§ 252.401(j) and §252.401(k)

Ms. Alger explained that the language in these sections were revised for clarification. The committee did not have any comments.

§ 252.401(m) There is an extra “I” in section m. No comments.

§ 252.402. Essential quality control requirements - chemistry

§ 252.402(c)

Ms. Alger explained that this section was changed to remove the duplicate requirement. The committee did not have any comments.

§ 252.402(d)(1)(iii) No comments.

§ 252.402(f)(3)

There were comments on the grammar in this section. This section should include “with each analytical batch”. Ms. Alger said that the language may be changed.

§ 252.402(h)(2) No comments.

§ 252.402(i)(1) No comments.

§ 252.402(m) No comments.

§ 252.402(n) No comments.

§ 252.404 – Essential quality control requirements - microbiology

§ 252.404(c)(1)(i)

Ms. Alger explained that the Department will allow pressure cookers for the sterilization of equipment; however the Department will not allow pressure cookers for the sterilization of media. Pressure cookers not recommended. The use of the word “should” in this section is intentional.

§ 252.404(c)(3)

Ms. Alger explained that the requirements for the use of optical counting equipment were removed because the requirements are found in the reference methods.

§ 252.404(c)(8) No comments.

§ 252.404(d) No comments.

§ 252.404(e) and § 252.404(f)

Ms. Alger explained that the requirements were not removed from these sections, but were moved to the general requirements in § 252.306. Ms. Steinman asked that now that the requirements have been moved to the general section, are people going to miss the requirements. Ms. Steinman expressed concern that some of the specific requirements may be lost.

Ms. Alger stated that a reminder paragraph would be added to each of the “Essential Quality Control” sections of Chapter 252. This reminder paragraph would point the reader to the equipment, reference materials, and supplies requirements of § 252.306.

§ 252.405. Essential quality control requirements - radiochemistry

Ms. Alger explained that the section did not need to be changed. The committee did not have any comments.

Subchapter E. Proficiency Test Study Requirements

No comments.

Subchapter F. Onsite Assessment Requirements

§ 252.601. Onsite assessment requirements

§ 252.601(a)

Dr. Donnelly explained that the change was made so that secondary NELAP laboratories do not require a Pennsylvania onsite assessment.

§ 252.601(f)

Ms. Alger explained that this requirement was added to clarify the requirements from the new TNI Standard.

Subchapter G. Miscellaneous Provisions

§ 252.707. Subcontracting

§ 252.707(b)

This section was revised to identify the subcontracted laboratory with the subcontracted laboratory’s ID number instead of the subcontracted laboratory’s name. The committee did not have any comments.

§ 252.708. Reporting and Notification requirements

§ 252.708(a)

Mr. Barrett commented that the changes to this section were just for drinking water and asked whether these requirements were the norm already.

Ms. Alger explained that Lisa Daniels was not able to attend the meeting to explain the reasoning for the requirements in § 252.708(a). Ms Alger explained that he reporting times were established to prevent laboratories from waiting to review the data and notify the Department and to ensure that public health was protected.

Mr. Barrett asked if the Laboratory Accreditation Program (LAP) was notified of all actions from PADWIS. Ms. Alger explained that the LAP was notified of the rejected data and was sometimes copied on the actions. DEP does take actions on reported data if it is incorrect.

§ 252.708(e)

Ms. Cappellini inquired about the frequency of the updates to the website listing for supervisor information. Ms. Alger explained that the internal database and documents are updated regularly as changes are made and that the website updates are infrequent. A procedure needs to be established to handle website changes.

§ 252.708(f) No comments.

Dr. Donnelly asked the committee if anyone wanted to revisit and discuss any of the previous sections.

Ms. Cappellini asked where the 2.5% tolerance for the verification of volumetric equipment came from in § 252.306(f)(9) and § 252.306(f)(10). Ms. Cappellini explained that she thought the volume tolerance may be too large. Ms. Alger explained that the requirement could be made tighter if people think it needs to be tighter. Mr. Eakin commented that he thought the reference could be changed to “equivalent to Class A or better”. Ms. Steinman added that she thought most laboratories preferred a number for the requirement. Ms. Alger explained that the Department could establish a sliding scale for the tolerances. Mr. Eakin explained that he didn’t think a sliding scale was necessary and added that he also felt that 2.5% was too loose. Mr. Medora explained that he thought that the 2.5% tolerance was fine and added that it was what New Jersey required.

Dr. Donnelly asked the committee if they wanted to keep the 2.5% tolerance. The committee’s consensus was “yes” to keep the 2.5% tolerance for the verification of volumetric equipment.

Other Business and Conclusion

Mr. Greco inquired about the status of Brian Kiser’s laboratory and the problems with laboratory supervisor qualifications. Ms. Alger explained that Mr. Kiser’s laboratory had entered into a consent order and agreement with the Department regarding the steps that must be taken to meet the supervisor requirements and the timeline for the fulfillment of those requirements.

Operator’s Course for Laboratory Supervisor

Ms. Steinman asked if anything has been done with regard to the operator’s course for laboratory supervisors. Ms. Alger spoke with the person in charge, and the Department is addressing the course. Ms. Steinman explained that the regulations are being revised and the group was not aware of the requirement for a supervisor course. Ms. Alger explained that it had been discussed approximately a year ago. Niki Kasi is very busy and may have forgotten about the discussion. Ms. Alger will follow-up with the group regarding the supervisor qualification course.

Reporting Limits

Ms. Alger explained that the Department will be restarting the project for the required quantitation limits for Pennsylvania for drinking water and non-potable water. The quantitation limit project was discussed in 2006 and has not been worked on since the last discussion. The quantitation limit project would give the committee something to work on in the interim of the regulation review process. Mr. Barrett explained that he believed that setting required quantitation limits is important.

Mr. Barrett explained that the problem is with permit limits because permit writers and reviewers do not have guidance on reasonable limits. Ms. Steinman stated that she supported the requirements for reporting limits, but not for MDLs. Ms. Alger explained that the Department wanted MDL data for informational purposes relating to reporting limits only. The Department does not intend to establish MDL requirements. Ms. Steinman explained that laboratories may not want to release MDL information to the Department. Ms. Cappellini stated that she thought that MDLs weren’t useful for most laboratories. Mr. Siglin questioned the relation of the quantitation limits to the requirements in 40 CFR Part 136.

Dr. Donnelly asked if EPA approval was needed to establish reporting limits. Ms. Alger stated that if the LAAC recommends developing limits, then the Department will follow-up with the EPA. Mr. Barrett stated that he thought the committee recommended setting limits in 2006. Ms. Alger said that the process was started, but was placed on hold since the PADWIS group said that the Department needed EPA approval. Ms. Alger explained that the Department is trying to establish limits because many limits in permits have been unrealistic.

Dr. Donnelly asked the committee if they wanted to make the recommendation to start the project to establish reporting limits. Mr. Barrett made a motion to gather data to establish reporting limits in drinking water and non-potable water. Mr. Eakin seconded the motion. Motion passed to send notification to laboratories to gather data to establish reporting limits.

Mr. Perry explained that the information must be submitted anonymously because of the right-to- know regulations. An anonymous system should be established. Mr. Medora explained that he thought the Department would get more information if they were flexible about the form of receipt. Ms. Alger said that the Department would be flexible and accept any data format. Ms. Steinman recommended that the data be technology specific.

Second Draft Regulation Discussion

Ms. Alger asked the committee for their thoughts regarding the second draft and inquired if the committee wanted a third draft of the regulations.

Mr. Lapato explained the regulation review process. The regulations are sent back to the EQB, and then they are sent out as a proposed rule for public comment and published in the PA bulletin. The

of 9 Laboratory Accreditation Advisory Committee (LAAC) Minutes of September 29, 2008 comment period is open for not less than 30 days. The Board’s comments are incorporated. The comments are reviewed and the comments and responses are published. The regulations are sent back to the LAAC and the process is restarted. If the draft is approved today, the regulations will not be sent to the EQB until November, and the timeline for public comment would be in December or January. March might be the date to close the comment period. Mr. Perry commented that the schedule was aggressive.

Accreditation Fees Discussion

Ms. Cappellini noticed that there was not much discussion regarding the fees in § 252.204.

Ms. Alger offered to explain the reasoning for the fees. The Department performed a workload analysis and the fees were based upon the work in laboratory accreditation. Current fees do not cover costs, and with the increased costs for travel and supplies the costs of laboratory accreditation will increas

Mr. Barrett observed that the fees were more expensive in the revised regulations. Ms. Alger explained that a lot of consideration on the costs was based on workload. Ms. Cappellini asked if consideration was given based on location of the laboratory. Ms. Alger explained that the Department did not want to charge laboratories that were farther away from Harrisburg, such as Erie, more money. The costs of doing business in Pennsylvania are the same regardless of location. The only difference is that out-of-state laboratories pay for travel costs. There may be an advantage between out-of-state laboratories for the laboratories that are regionally closer to Harrisburg.

Draft Approval Discussion

Vice Chair Dr. Daniel Donnelly asked the committee if they wanted to recommend moving forward on the regulations. Mr. Dan Lapato explained that the committee may make recommendation to send draft regulation package to the EQB. The LAAC must make a yeah or nay vote to send package to EQB.

Mr. Stephen Morse made a motion to approve the second draft regulation with the discussed changes to the regulation. The motion was not seconded. Mr. Gene Greco indicated that he wanted to see a third draft before voting for approval. Ms. Aaren Alger stated that she would have a third draft for the next meeting.

Meeting Schedule

The next meeting of the LAAC will be held on Thursday, December 11, 2008. A third draft of the regulations will be presented for discussion at the December 11th meeting.

Adjourn

Mr. Gene Greco made a motion to adjourn the meeting. Ms. Anita Martin seconded the motion. The motion passed unanimously. Vice Chair Dr. Daniel Donnelly adjourned the meeting at 12:25 P.M.