Pace Clarification Response Cont 2.pdf

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Signature Manifest

Document Number: ENV-POL-CORQ-0002 Revision: 00

Title: PT - Environmental Sciences

All dates and times are in Central Time Zone.

ENV-POL-CORQ-0002

QM Approval

Name/Signature Title Date Meaning/Reason

Kirstin Daigle (007621) Director - Environmental Quali 02 Jun 2021, 10:20:05 AM Approved

Management Approval

Name/Signature Title Date Meaning/Reason

Kirstin Daigle (007621) Director - Environmental Quali 01 Jun 2021, 11:14:09 AM Approved

Michael Fuller (005537) SVP, COO - Environmental Scien 01 Jun 2021, 11:50:59 AM Approved

POLICY: PT - Environmental Sciences Approved & Issued by: Corporate Quality – Environmental Sciences Pace Analytical Services, LLC (PAS) COPYRIGHT © 2021 Pace Analytical Services, LLC.

1.0 POLICY STATEMENT

This policy establishes the requirements for participation in Proficiency Testing (PT) for testing laboratories affiliated with the environmental sciences division (ENV) of Pace Analytical Services, LLC (PAS).

Participation in PT enables the laboratory to demonstrate competency to measure for a particular analyte using a specific test method or procedure, to follow instructions, and to manage a project to meet expectations.

Acceptable PT performance provides confidence that the data and test result generated by the laboratory’s procedure is accurate. When the study is an interlaboratory comparison, acceptable performance indicates the test result produced is comparable to results produced by other participating laboratories and to the reference laboratory.

This policy includes requirements for PT management, scheduling, ordering, handling, and analysis of PT samples; specifications for evaluation and reporting of PT results and required procedures and guidelines for investigation and corrective action of any PT results scored “not acceptable”.

1.1 Risk Mitigation

PT performance is used by regulatory bodies, accreditation bodies, and federal and state agencies to qualify laboratories for certification, accreditation, and/or to approve the laboratory to provide testing services for their data needs.

PT performance is used by Pace customers to assess the laboratory’s capability to provide data and test results that meet their data quality objectives (DQO’s) and to verify the test results are fit for use.

PT performance is used by data users to provide confidence in the data and test results they use to make decisions that affect public health and safety and the quality of our environment.

The requirements of this policy ensure that the PT samples are analyzed using the same procedures used for routine environmental samples so that PT performance reflects day to day results.

2.0 SCOPE AND APPLICATION

2.1 Scope

This policy applies to all ENV that provide testing services except those operating as Aerobiology.

The term “laboratory” in this policy refers to any location that generates test results regardless of whether the testing is done in a fixed building, a mobile unit, in the field, or if the location is internally referred to as a service center.

Approved & Issued by: Corporate Quality – Environmental Sciences Pace Analytical Services, LLC (PAS) COPYRIGHT © 2021 Pace Analytical Services, LLC.

The local Quality Manager (QM) may, at their discretion, create a local SOP for PT management to implement the requirements of this policy. If a local SOP is created, the SOP must be in conformance with this policy.

Laboratories may not create separate process or test method SOPs for the analysis of PT samples. Analytical activities must be performed using the same test method SOPs that are used for routine environmental samples.

2.2 Application

This policy applies to PT used for certification and accreditation and as required for government or non-government programs.

This policy does not apply to PT or round robin studies where the test results are used solely by Pace, such as an internally managed double or single-blind PT study. Requirements for these evaluations are established by the management team responsible for the internal project.

3.0 DEFINITIONS

Accreditation: Recognition from a government or non-government body that the laboratory has met requirements of or is competent to work to a specified standard.

Certification: Certification is used for verifying that personnel have adequate credentials to practice certain disciplines, as well as for verifying that products meet certain requirements.

DW: Drinking Water

Field of Accreditation (FOA): Those matrix, technology/method, analyte combinations for which the accreditation body offers accreditation.

Field of Proficiency Testing (FoPT): Matrix, technology/method, analyte combinations for which the composition, spike concentration ranges, and acceptance criteria have been established by the TNI PT Program Executive Committee (PTPEC).

Interlaboratory Comparison: Organization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions.

Laboratory: Any ENV location, however named that performs testing in a fixed location, in a mobile unit or in the field.

NPW: Non-Potable Water

Performance Evaluation Sample: a reference sample provided to a laboratory for the purpose of demonstrating that the laboratory can successfully analyze the sample within limits of performance specified by the Agency. The true value of the concentration of the reference material is unknown to the laboratory at the time of the analysis. (40CFR141)

Approved & Issued by: Corporate Quality – Environmental Sciences Pace Analytical Services, LLC (PAS) COPYRIGHT © 2021 Pace Analytical Services, LLC.

Proficiency Testing (PT): A means to evaluate a laboratory’s performance under controlled conditions relative to a given set of criteria, through analysis of unknown samples provided by an external source. (TNI 2016).

PT Provider (PTP): A person or organization accredited by a TNI-approved Proficiency Testing Provider Accreditor to operate a TNI-compliant PT program. (TNI)

PT Supplier: A person or organization that supplies PT samples. A PT supplier may be a PTP, however PTP is reserved for vendors that are TNI approved.

Proficiency Testing Reporting Limit (PTRL): A statistically derived value that represents the lowest acceptable concentration for an analyte in a PT sample, if the analyte is spiked into the PT sample.

Remedial PT: A scheduled or supplemental PT study that is used by the laboratory to re-establish performance history after successive unacceptable scores.

Repeat PT Failure: An unacceptable score received for the same test method or FoPT during an 18-month timeframe. (Internal Definition).

Revocation: The total or partial withdrawal of a laboratory’s accreditation by an accreditation body.

Scheduled PT Study: A single complete sequence of circulation and scoring of PT samples to all participants in a PT program. The study must have the same pre-defined opening and closing dates for all participants. (TNI)

Scheduled PT Study Closing Date: The calendar date by which all participating laboratories must submit analytical results for a PT sample to a PT Provider. (TNI)

Scheduled PT Study Opening Date: The calendar date that a PT sample is first made available to all participants of the study by a PT provider. (TNI)

Study Duration: The time frame between the open and close date of a study.

Supplemental PT Study: A PT sample that may be from a lot previously released by a PT provider that meets the requirements for supplemental PT samples given in Volume 3 of the TNI standard, but that does not have a pre-determined opening and closing date.

(TNI)

Supplemental PT may also be known as quick turnaround PT. Although there is no predefined close date for supplemental PT; the study duration for supplemental PT may not exceed 45 days. (V3 TNI Standard) from the ship date to the date the data are reported to the PTP.

Supplemental PT Study Closing Date: The calendar date the laboratory submits the result to the PT Provider. (TNI)

Supplemental PT Study Opening Date: The calendar date the PT Provider ships the sample to a laboratory. (TNI)

Approved & Issued by: Corporate Quality – Environmental Sciences Pace Analytical Services, LLC (PAS) COPYRIGHT © 2021 Pace Analytical Services, LLC.

Suspension: The temporary removal of a laboratory’s accreditation for a defined period of time, which shall not exceed six months or the period of accreditation, whichever is longer, in order to allow the laboratory time to correct deficiencies or area of non-conformance with the standard.

USEPA: United States Environmental Protection Agency

Withdraw: Not report results for a PT study, any PT sample included in the PT study, or for an analyte for which the laboratory holds certification or accreditation.

4.0 POLICY

4.1 PT Management

The laboratory’s PT program is managed by local quality personnel under the direction of the QM. The QM is responsible for managing implementation of this policy, personnel training on this policy, and monitoring work activities to ensure the requirements of this policy are adhered to.

4.2 PT Participation Requirements

Each laboratory must participate in PT as required to obtain and maintain certification and/or accreditation, meet regulatory requirements, and satisfy other government, non-government, and client-specific requirements for the testing services offered.

If there are no external certification, accreditation, or other program requirements for PT participation for the tests offered, participation requirements for the laboratory will be established by the Corporate Quality Director based on the scope of testing performed.

For example, if the laboratory offers testing for drinking water (DW) and non-potable water (NPW) and the state agencies the lab is certified by does not offer certification for NPW, and the NPW method performed is not for compliance monitoring for NPDES (which is covered by the DMR-QA program), then the Corporate Quality Director may require the laboratory to participate in an annual WP (Water Pollution) Study to assess the laboratory’s proficiency for the test method offered, if an appropriate PT sample is available.

PT requirements for drinking water, DMR-QA, and TNI are provided in Appendix A for reference. These programs apply to the majority of laboratories in our division.

This policy does not include PT requirements for every lab’s situation. This information must be obtained and understood by local quality personnel as part of the local PT management program.

4.3 PT Scheduling & Timeframes

The maximum and minimum timeframes between PT studies and the way the timeframe is measured varies by program and PT type.

Approved & Issued by: Corporate Quality – Environmental Sciences Pace Analytical Services, LLC (PAS) COPYRIGHT © 2021 Pace Analytical Services, LLC.

Examples of ways these timeframes are measured include but are not limited to:

Acceptable score must be within a certain number of months from the date of application of certification or accreditation.

Acceptable score must be within a certain number of months from the date certification or accreditation is granted.

Successive studies must be within a certain number of days or months between study closing date, study closing to opening date, study shipping date, or date of analysis.

Participation is annual by calendar year or annual by some other measure.

Local quality personnel must be familiar with their program requirements and schedule PT studies to satisfy participation requirements within the timeframes required for each program.

4.4 PT Study Type

Quality personnel must schedule participation in PT studies so that participation and timeframe requirements are routinely met with “Scheduled” PT Studies, unless otherwise specified by the program for which PT results will be used.

Participation in “Supplemental” PT Studies should be limited to PT needed for initial accreditation, for remedial PT used to reestablish performance history after repetitive failure, or to prevent suspension or loss of certification or accreditation due to a PT management oversight.

See Section 3.0 for definitions of Scheduled and Supplemental PT.

4.5 Requirements for Purchasing PT Samples

Unless a specific PT Provider (PTP) is specified by program for which PT results will be used, the laboratory must purchase PTP that is an ENV approved vendor.

All ENV approved PT vendors are ISO and/or TNI accredited.

Some programs, such as USEPA CLP and AIHA-LAP,LLC, and/or Pace customers will provide PT samples directly to laboratories in their programs or designate a specific PT vendor the laboratory must use. In which case, the laboratory will comply with these specifications.

Labs Accredited by New York: The New York Department of Health (NYDOH) provides PT samples directly to laboratories that hold direct certification (non-TNI) or TNI accreditation with NY ELAP. The cost of these PT samples is included in the accreditation fee. Therefore, many laboratories opt to use these PT since they have paid for them. All NY ELAP accredited laboratories have the option to “opt out” of receiving the NY PT and may purchase PT samples from any TNI accredited PTP. For purposes of this policy, ENV labs accredited by NY ELAP may use NY PT or purchase PT from any other ENV approved PTP that is TNI accredited.

Approved & Issued by: Corporate Quality – Environmental Sciences Pace Analytical Services, LLC (PAS) COPYRIGHT © 2021 Pace Analytical Services, LLC.

Preferred status may be granted to an approved PTP vendor by the Corporate Quality Director based on the PTP’s capability to interface with Pace purchasing programs, their record of customer service, added value offerings such as online PT data management, and other contractual agreements.

If preferred PTP are designated, laboratories must purchase their PT samples from these vendors unless the PTP does not offer the PT sample needed or the PTP is specified by the regulatory program for which PT results will be used.

The list of approved PT vendors and PTP designated preferred status is kept by the corporate purchasing group and is not listed in this policy in order to maintain vendor confidentiality.

PT samples, when purchased directly by the laboratory must be ordered following the process established by Pace’s corporate purchasing group.

PT orders, when not placed by local quality personnel, must be approved by quality personnel before the order is submitted to the corporate purchasing group to ensure the PT sample ordered meets applicable requirements for the programs for which results will be used.

Inquiries about the status of PT orders to PTP will be made by the corporate purchasing group unless otherwise directed by this group. Local quality personnel who need information about the status of an order must inquire with corporate purchasing before contacting the PTP directly. This policy is in place to preserve the point of contact (POC) agreements that have been established between the PTP and Pace’s purchasing group.

4.6 PT Receipt & Storage

The condition of the PT sample shipment must be checked by local quality personnel to verify the materials received match the purchase order and shipping manifest and to make sure there are no problems with the shipment, such as broken containers or missing study information.

If problems are found, local quality personnel must notify the PTP by email and carbon copy corporate purchasing on the correspondence and resolution. Records of correspondence must be retained with PT study records.

Prior to and after log-in, PT concentrates and/or prepared samples must be stored in accordance with the study instructions provided by the PTP.

Approved & Issued by: Corporate Quality – Environmental Sciences Pace Analytical Services, LLC (PAS) COPYRIGHT © 2021 Pace Analytical Services, LLC.

4.7 PT Log-In and TAT Requirements

PT samples must be logged in to the LIMS and tracked using the same procedures used to track status and on-time-delivery (OTD) of routine environmental samples.

Log in should be completed within 2 business days of receipt of shipment to ensure adequate time to meet deadlines.

TAT specifications for PT workorders are established in this policy to:

Ensure there is ample time for technical personnel to complete analytical work, to conduct primary and secondary data review, and to resolve quality control (QC) exceptions with corrective action prior to the close date of the study.

Provide quality personnel sufficient time to conduct completeness review of the data and test report to ensure project specifications were met and to schedule and complete rework for problems found during completeness review prior to the close date of the study.

The amount of time allotted to analytical and quality activities is based on the number of days that remain from the date of PT sample receipt to the study close date.

If time remaining is, then TAT is:

- ≥ 40: 28 Day.

- ≥ 28 and < 40: 21 Day.

- < 30: TAT = 20% of days remaining; round up.

Examples of TAT Guidelines Applied:

# Days Day Due to Quality # Days Analytical # Days Quality

5 Day 4 4 1

10 Day 8 8 2

15 Day 12 12 3

20 Day 16 16 4

25 Day 20 20 5

28-40 Day 21 21 Minimum: 7

40+ Day 28 28 Minimum: 12

Work area supervisors, managers and team leaders must manage the backlog to ensure these time frames are met. Work area management must

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also keep quality personnel informed of the status of the work in the same manner they would the PM of any routine project.

Quality personnel must track the status of the PT project in the same way a project manager (PM) would for routine environmental samples and alert the GM and work area management when results and data have not been received on-time.

4.8 PT Preparation, Analysis and Data Review Requirements

PT samples or concentrates must be made ready for use per the instructions provided with the study.

After which, prepared PT samples must be prepared and analyzed by the same personnel, using the same SOPs, same acceptance criteria and decision-making used for routine environmental samples.

Primary and second level data review must be completed prior to delivery of data and test result to quality personnel.

Quality personnel must perform a completeness review prior to submission of the PT results to the PTP.

Data and completeness review must be conducted in accordance with any applicable corporate policy and SOP and any local SOPs for this process.

4.9 PT Reporting Requirements

PT results must be reported in accordance with the PT study instructions and in accordance with any relevant program requirements for which the PT are used.

The PTRL is a statistically derived value that represents the lowest acceptable concentration for an analyte present in a PT sample, if the analyte is spiked into the PT sample, at the lowest possible spike concentration allowed for the FoPT.

The PTRL is used as the reporting limit (RL) for PT in the same way a customer or program may specify a project specific RL. However, unlike RL for routine environmental samples, the PTRL is not adjusted for dilution or sample volume; it is a fixed value.

Laboratories must follow the PTRL reporting guidelines specified in the 2016 TNI Standard for all Scheduled and Supplemental PT studies, regardless of the version of the TNI Standard the TNI or non-TNI Accreditation Body (AB) references or risk an unacceptable PT score.

Although some TNI ABs have not adopted the 2016 TNI Standard, all TNI ABs have agreed to accept the 2016 TNI Standard for PTRL reporting and scoring because the reporting and scoring criteria between different

Approved & Issued by: Corporate Quality – Environmental Sciences Pace Analytical Services, LLC (PAS) COPYRIGHT © 2021 Pace Analytical Services, LLC.

versions of the TNI Standard are mutually exclusive. The only time ENV Labs should not perform PTRL reporting is when alternate reporting instructions are provided with the PT study.

- PTRL are established by the TNI PT program for each TNI FoPT and published in PTRL Tables that are posted on the TNI website.

- Requirements for PT are provided in Volume 1 of the TNI Standard.

- Guidance on PTRL Reporting is provided in TNI Guidance Document TNI VIMI 2016 Standard Updated Guidance on Proficiency Testing Reporting Limit (PTRL), GUID-3-114-Rev.0, October 15, 2018.

Local quality personnel must be familiar with PTRL reporting, set up LIMS projects with these specifications, train staff to evaluate and report data to the PTRL, and verify that the results submitted by the analytical groups are reported to the proper PTRL value.

See Appendix B for examples of PTRL evaluation, reporting and scoring.

Measurement uncertainty for radiochemistry is not usually reported with the PT result for Scheduled and Supplemental PT.

Although not reported, the laboratory must maintain the measurement uncertainty with the test result in the laboratory’s PT study data records.

4.10 Submission of PT Results

PT results must be submitted in accordance with the PT study instructions on or before the study close date. Results submitted or received after the close date are generally not accepted and failure to report results is often considered an overall performance failure.

When PT are used for on-going certification/accreditation purposes, the laboratory must authorize the PTP to submit the laboratory’s scores directly to the government AB (AB) or non-government AB (NGAB) and identify which ABs to send these results too.

When results are submitted to the PTP via a data portal, the upload must be done by EDD unless the PTP cannot accept EDD, and manual data entry is the only option.

Quality personnel must obtain the EDD specifications and setup from the PTP and coordinate EDD development with local or corporate IT personnel. Most PTP will assist laboratories with the process to ensure it works successfully. Quality and IT must allot adequate time to develop and test the EDD prior to the close date of the first study the EDD is used.

Approved & Issued by: Corporate Quality – Environmental Sciences Pace Analytical Services, LLC (PAS) COPYRIGHT © 2021 Pace Analytical Services, LLC.

For PT results uploaded or entered into a data portal, the data populated must be checked by quality personnel for completeness and transcription accuracy.

When PT results are manually entered the accuracy of transcription must be checked by a second individual.

Records of these checks must be documented with date and initials of the person that performed the check and retained with the PT study records.

4.11 Withdraw Requirements

Failure to report results for an entire study, one or more PT samples received in the study, or for an analyte for which the laboratory offers testing is called withdraw.

Withdraw should be rare and only under the same circumstances that a laboratory would cancel a project for a Pace customer.

These circumstances are generally limited to:

Complete loss of PT sample and a replacement PT sample cannot be obtained prior to the study close date.

The test method has been taken off-line and no test results are being reported to any customer.

The decision to withdraw must be made by the local QM and the General Manager (GM) with mutual understanding of the potential impact of the decision.

These impacts may include but are not limited to:

- Suspension or loss of certification or accreditation if acceptable results are not received in the next study or if results are not received within required timeframes.

- Loss of business. Some clients and agency programs use PT performance to determine the volume of work that will be sent to a laboratory or whether the lab will be selected to support their testing needs.

When a decision to withdraw has been made, the QM must record the decision, rationale for the decision, and impact of the decision using a Qualtrax workflow for PT Withdraw Tracking.

The Qualtrax data will used by corporate and local quality personnel to monitor the frequency of withdraw and identify the common reasons for purposes of continuous improvement and preventive action.

4.12 Improper PT Handling and Practices

There are several practices that are considered improper and unethical when applied to PT prior to the close date of the study.

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Laboratories that engage in these practices prior to the close date of the study are at risk for immediate revocation of certification/accreditation by the accrediting body and/or removal from an affected client program or project.

Employees that engage in these practices prior to the close date of the study are subject to disciplinary action up to and including termination in accordance with Pace’s Code of Conduct and Ethics Policy.

Do not engage in any of the following prior to the close date of a study:

Subcontract analysis of PT to any other laboratory in or out of the Pace network.

Knowingly analyze a PT sample for another laboratory.

Communicate with individuals at another laboratory (in or out of Pace) about the analysis or the results of a PT sample. Laboratory personnel should not seek counsel from corporate personnel for purposes other than communications that would normally take place with testing of routine environmental samples.

For example, if the laboratory routinely requests assistance from corporate technical or quality personnel to determine the validity of a test results for routine environmental samples before submitting the result to the customer, these communications may also occur for PT samples. Otherwise, all decisions about the PT sample including which value to report must be made by the laboratory without influence by external parties.

Analyze the PT sample multiple times to average the result or to choose the best result, unless this practice is required by the test method and is also performed for all routine environmental samples.

Analyze the PT sample using a process or procedure or QC different than routine environmental samples except where specified in the study instructions.

Attempt to obtain the assigned value of a PT sample from a PTP prior to the close date of the study.

Analyze QC standards provided by a PTP side by side with the PT sample in an attempt to gauge whether the PT result is accurate. These QC standards are only appropriate to verify effectiveness of corrective actions prior to analysis of a PT sample used to reestablish performance history after an unsuccessful score.

During the study, these practices are considered extraneous and intentional efforts to boost laboratory performance above what would normally be achieved with analysis of routine environmental samples. This is an improper practice because the PT results do not accurately reflect the quality of data routinely provided that

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could be used to make decisions that affect public health and safety and the environment.

After the study, some, but not all, of these activities are acceptable to help the laboratory gain information to resolve a method performance issue found from an unacceptable PT evaluation. Consult with your local QM to determine which practices may be allowed after the study close date.

4.13 PT Failure Investigation

All PT results scored “Not Acceptable” must be promptly and thoroughly investigated. The investigation process and documentation of results must follow and be recorded using the Qualtrax CAPA workflow for PT Investigation. Quality personnel are responsible for coordinating the investigation to ensure it is completed within required timeframes and that it is complete.

Investigations of PT failures must not be superficial and must be as thorough as necessary to identify the cause for the unacceptable sore.

If the cause of the problem is not a transcription or upload error, a technical investigation must be performed. All technical investigations must be performed by the Department Manager, Supervisor, of the department that performed the test. If the laboratory is TNI accredited, the investigation may be assigned to the employee that has been approved by the TNI AB to serve as the acting technical manager for the relevant discipline.

The investigation must be recorded using the Corporate PT Investigation Checklist, for the analyte group relevant to the test methods for which an unacceptable score was obtained. The checklists may be downloaded from the document management eDMS portal. The completed checklist must be attached to the Qualtrax workflow instance as evidence of the investigation and for historical recordkeeping.

The PT Investigation checklists are technology specific and designed to guide the investigator through a comprehensive progressive technical review process to ensure all potential causes for the PT failure are assessed.

PT failure investigations must be completed within 15 days from date of receipt of results or sooner when required by program.

Because PT samples are analyzed using the same procedures used for routine environmental samples, the cause for an unacceptable score must be promptly identified to determine if the problem could affect previously reported or future test results.

If a data impact assessment is needed, it must be performed following the corporate SOP for this process. Currently, SOP ENV-SOP-CORQ-0017.

Approved & Issued by: Corporate Quality – Environmental Sciences Pace Analytical Services, LLC (PAS) COPYRIGHT © 2021 Pace Analytical Services, LLC.

After the investigation is complete, corrective actions to address the root cause(s) must be completed within 30 days, unless a shorter timeframe is required by program, in which case the lab must abide by the shortest timeframe. The 30-day timeline for corrective action does not include analysis of a remedial PT, if remedial PT are required. See Section 4.14.

Quality personnel are responsible for coordinating the corrective action process to ensure actions are completed within required timeframes. The individuals to which the actions are assigned are expected to complete the actions within the agreed timeframe and/or within 30 days, whichever is sooner.

Corrective action must be documented with the PT investigation in the Qualtrax workflow instance. Documentation of corrective actions for whole effluent toxicity (WET) must include a copy of the Standard Reference Toxicant (SRT) control chart relevant to the PT study.

When the root cause of the failure is technical, the effectiveness of corrective action and/or return to analytical control must be demonstrated with an independent QC Standard and/or with on-going monitoring of routine QC before another PT is analyzed. Successful analysis of another PT sample is not a corrective action. Corrective action is an action taken to correct and prevent recurrence of a problem. PT demonstrates proficiency or detects a problem; PT does not correct or prevent problems.

External parties that use PT results to assess the qualifications of the laboratory may request the results of PT investigation and corrective action for any result scored not acceptable. All ENV laboratories must comply with these requests and submit the information within the timeframe requested.

Laboratories are cautioned that when the request is from a TNI AB, the laboratory has 30 days from date of request to provide the information or the laboratory’s TNI accreditation may be suspended or revoked.

Quality personnel must be familiar with the corrective action timeframe requirements for each regulatory program and laboratory management must manage the investigation and corrective action process to meet these timeframes.

4.14 Remedial PT

The decision to perform remedial PT is made by the local QM based on the consequence of the PT failure and whether on-going performance requirements are met.

Remedial PT must be performed when the lab is at risk for suspension or loss of certification or accreditation due to repeat failure or failure to meet participation

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requirements within the required timeframe. Remedial PT are not required after each unacceptable score so long as the required performance history is maintained.

For example:

For TNI accreditation, the laboratory must maintain a performance history of successful evaluations in the last 2 out of 3 attempts, with the timeframe between no more than 7 months apart. As long as these conditions are met after an unacceptable score, there is no requirement for a remedial PT (for TNI).

When a remedial PT is not required, the laboratory must still investigate the failure and perform corrective action. When the cause for failure is not clerical or administrative, the effectiveness of corrective action and return to analytical control is assessed with an independent QC Standard. Sustainability of the actions taken over time is monitored with routine quality control and by internal audits.

When a remedial PT is necessary, the PT sample must not be analyzed prior to corrective action. When the cause of the failure is technical in nature, corrective action must be verified with a QC standard, preferably, an independent QC standard, prior to analysis of the remedial PT.

Some PTP offer to automatically send the laboratory a Supplemental PT for use as a remedial PT any time a result is scored “not acceptable”. ENV laboratories must decline this service. Decisions to purchase and perform remedial PT must be made by the local QM on a case-by-case basis.

The PT Study type used for remedial PT depends on program requirements and the timeframe in which proficiency must be restored to maintain certification/accreditation or to provide continuity in service to customers.

Supplemental PT are recommended for remedial PT because there is no pre-defined close date and because the PT sample can be customized if needed to meet program requirements.

Some programs require that the PT used to re-establish performance history is spiked with the analyte(s) missed to verify the laboratory’s capability to properly identify and quantify the analyte. Since the composition of a PT sample in a Scheduled PT is randomized; Scheduled PT may not meet this requirement.

If the original PT was purchased from an ENV approved vendor, the remedial PT must be purchased from the same PTP that supplied the original PT, unless this PTP cannot provide the sample needed in the timeframe needed, or if the PTP has lost their approved vendor qualification status due to a performance concern.

If the original PT was not purchased from an ENV approved vendor, the remedial PT must be purchased from an ENV approved PTP.

Approved & Issued by: Corporate Quality – Environmental Sciences Pace Analytical Services, LLC (PAS) COPYRIGHT © 2021 Pace Analytical Services, LLC.

4.15 Stop Work After Repeat PT Failure

Repetitive PT failure indicates there is a problem with the laboratory’s process. If the source of the problem cannot be determined or resolved in a timely manner, laboratory management must assess the impact of the situation on usability of data and test results for routine environmental samples and determine if the test method should be taken offline until the problem is resolved and proficiency regained.

Repeat failures investigations must include a review of trend analysis of the failing PT analyte(s). The trend analysis must review whether the PT results indicate a systems bias for the method(s) or does the data indicate a one – off failure. The trend analysis must be documented in the workflow.

5.0 RESPONSIBILITIES

Laboratory management personnel are responsible for implementation of and training staff on this policy.

ENV employees are responsible to comply with the standards established in this policy.

6.0 ATTACHMENTS

Appendix A: PT Participation & Performance Requirements

Appendix B: Examples of PTRL Reporting

7.0 REFERENCES

ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories.

TNI Standard, Volume 1, Management and Technical Requirements for Laboratories Performing Environmental Analyses, Module 2: Quality System Requirements. EL- V1M2-2016-Rev2.1, The NELAC Institute (TNI), December 2016.

Effectively Managing Your PT Program, TNI PT Expert Committee Members: Daigle, Huff, Todaro, Cairns, DeMarco, TNI Winter Forum Presentation, Mentor Session.

January 26, 2021.

TNI Guide-3-114-PTRL, current version.

TNI Small Lab Handbook

ENV-SOP-CORQ-0018, Corrective and Preventive Action, Current Version

Laboratory Quality Manual, current version.

Pace Ethics Policy, CORQ-POL-0004, current version.

ENV-SOP-CORQ-0017, current version.

Approved & Issued by: Corporate Quality – Environmental Sciences Pace Analytical Services, LLC (PAS) COPYRIGHT © 2021 Pace Analytical Services, LLC.

8.0 REVISION HISTORY

This Version:

Section Description

NA This is the first version of this policy.

This Version supersedes:

Document Number Title Version

Various Local SOPs based on ENV-SOT-CORQ-0018 All Versions

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APPENDIX A: PT Participation Requirements by Regulatory / Accreditation Program

This appendix summarizes key PT participation and performance history requirements for the Safe Drinking Water Act (SDWA), the National Pollution Discharge Elimination System (NPDES), and for TNI Accreditation (TNI). These programs are included in this policy because they pertain to the majority of laboratories in the ENV division. The TNI PT Standard is also the basis for PT required by DoD/DOE and is commonly used by non-TNI AB, industry organizations and client-based PT programs.

This appendix does not include all program requirements. The information herein is intended to highlight the variance between programs and the level of detail that must be considered when managing a PT program.

The local quality manager (QM) must be familiar with the requirements of the programs for the laboratories they are responsible for and laboratories must meet the requirements of each program that applies to testing services offered.

For example, laboratories certified for drinking water must meet SDWA requirements. If the laboratory is also TNI accredited for drinking water, the laboratory must in addition to SDWA, meet PT requirements of TNI. Neither program fully satisfies the requirements of the other.

On top of SDWA, and TNI, the laboratory must also meet any state-specific requirements imposed by the certification body or the AB.

The information provided in the following sections supplement the main body of the policy and does not supersede the requirements in the main body of this policy unless otherwise specified.

Information in this appendix is subject to change outside of this policy’s review and update cycle.

Users of this policy are advised to refer to the regulation, administrative code, Standard, or contract that governs PT requirements for the testing services offered for a complete description of program requirements.

Safe Drinking Water Act (SDWA)

Any laboratory that analyzes drinking water samples must be certified by the State (from which samples are received) or by the EPA.

Certified laboratories must analyze and pass at least 1 performance evaluation (PE) sample per calendar year for each test method certified.

The PE (PT) sample may be provided by the EPA, the State, or a third party that has approval to provide PT from the EPA or State.

References:

Code of Federal Regulations: 40 CFR Part 141, 7-1-19 Edition

Manual for the Certification of Laboratories Analyzing Drinking Water, Criteria and Procedures Quality Assurance, Fifth Edition, USEPA Office of Water, EPA 815-R-05-004, January 2005

- Supplement 1, EPA 815-F-08-006, June 2008

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- Supplement 2, EPA 815-F-12-006, January 2005 (Cryptosporidium)

National Pollution Discharge Elimination System (NPDES) – DMR-QA

Laboratories that provide compliance testing for major and minor permittees under the Clean Water Act must participate in the annual Discharge Monitoring Report – Quality Assurance (DMR- QA) Study as requested by their customers. The permittee (customer) is responsible for requesting the labs they use for compliance monitoring, analyze PT samples for test methods/ analytes that are in their NPDES permit and included in the study.

The study, which is announced by the USEPA with instructions, usually includes PT for chemistry, microbiology, and Whole Effluent Toxicity (WET) test methods. WET participation is required even if the test conditions used do not exactly match those in the Study.

The PT samples must be purchased from the PTP designated in the study or the laboratory may use a Scheduled WP Study so long as the WP Study meets the closing date timeframes specified in the study instructions, and the WP study includes all DMR-QA analytes.

The laboratory is responsible for providing the result of PT to their permittee. For any result scored “not acceptable”, an investigation and corrective action is required, and the results of corrective action must be provided to the permittee within the study timeframes.

If a remedial PT is used for corrective action, the remedial PT may be a supplemental PT (quick turnaround) or a scheduled WP PT with data reported to the PTP by the date / timeline specified in the study instructions.

See the USEPA DMR-QA website for more information:

https://www.epa.gov/compliance/discharge-monitoring-report-quality-assurance-study-program

TNI Standard (STD-ELV1-2016-Rev 2.1)

Participation & Performance History for Chemical, Radiological, Asbestos & Microbiology:

ENV laboratories that seek or hold TNI accreditation for chemical, radiological, asbestos or microbiology fields of accreditation (FoA) with a matching field of proficiency testing (FoPT) must participate in at least 2 PT studies on a semi-annual basis and maintain an acceptable score of 2 out of 3 attempts for each FoPT.

For initial accreditation, the PT must be performed no more than 18 months prior to accreditation from the AB, there must be at least 7 calendar days between the closing date and opening date of successive studies, and the closing date of the most recent PT must be no more than 6 months prior to the date of application for accreditation.

For continuing accreditation, participation in PT must be semi-annual with no more than 7 months between successive PT and laboratories must maintain a successful performance

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history of 2 out of 3 acceptable scores in last 3 attempts. Failure to meet either the participation or performance requirement may result in suspension or revocation.

Except for drinking water FoPT, where a PT per test method is required per 40CFR141, FoPT are technology-based. Technology-based means that when the laboratory is accredited for multiple test methods for the same FoPT in the same FoPT matrix and both methods use the same technology, the laboratory may analyze the PT sample by one of those test methods and the test results will be used to evaluate proficiency for both test methods. An unacceptable score by any test method will be applied to all test methods.

For example, Test methods EPA 200.7 and SW-846 6010C use the same technology and are methods approved to test for metals in non-potable water. Therefore, analysis of the PT sample by either method covers the PT for both methods. (PT are technology based)

Although test methods EPA 508 and EPA 551.1 use the same technology to measure endrin in drinking water, separate PTs are required because SDWA requires PT per test method.

However, both use the same technology, therefore in the semi-annual study, the PT sample may be analyzed by one test method in the first study and the other test method in the second study and requirements for both programs will be met so long as the PT are analyzed in the calendar year.

Participation & Performance History for Whole Effluent Toxicity (WET):

ENV laboratories that are TNI accredited for WET FoPT must participate in at least 1 PT Study per the timeframes specified.

For initial accreditation, the PT Study closing date must be within 12 months of initial accreditation.

For continued accreditation, participation in one study is required per calendar year.

Acceptable options for ENV laboratories to meet this requirement include participation in the EPA DMRQA WET Study, or participation in annual PT studies where there is no more than 14 months between closing date of each study.

References:

TNI Standard, Volume 1, Management and Technical Requirements for Laboratories Performing Environmental Analyses, Module 2: Quality System Requirements. EL-V1M2- 2016-Rev2.1, The NELAC Institute (TNI), December 2016.

TNI Small Lab Handbook

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Appendix B: Examples of PTRL Evaluation, Reporting and Scoring Content partially excerpted from the TNI Small Lab Handbook

PTRL FoPT: Drinking Water Benzene (TNI FoPT Table) Lowest Spike Concentration Allowed 2 ug/L

Acceptance Criteria ± 40% Acceptance Limits 1.2 to 2.8 ug/L

PTRL 1.2 ug/L

When analyzing a DW PT sample for benzene, evaluate the test result to 1.2 ug/L and:

Report any numerical value less than 1.2 ug/L as <1.2 ug/L.

Report any numerical value greater than 1.2 ug/L as the numerical value obtained.

Scoring Example 1:

Actual Spiked Concentration 2.20 ug/L Acceptance Limits 1.32 to 3.08 ug/L

Lab LOQ 2.0 ug/L Lab Result 1.85 ug/L

If the lab reports the 1.85 ug/L result as <2.0 ug/L (LOQ), the result will be scored “Not Acceptable” because the analyte was spiked, and the concentration found is above the PTRL.

If the lab reports the lab result as 1.85 ug/L, the result will be scored acceptable even though it is less than the LOQ. The result reported is within the acceptance limits of the study and the result is above the PTRL.

Scoring Example 2:

Assigned Value <1.20 ug/L Actual Spiked Concentration 0

Acceptance Limits NA Lab LOQ 2.0 ug/L

Lab Result 0.55 ug/L

If the lab reports <1.2 ug/L (<PTRL), the result will be scored acceptable.

If the lab reports <2.0 ug/L (LOQ), the PTP will score the result acceptable but this evaluation may be overturned by some ABs for failure to report to the PTRL.

If the lab reports 0.55 ug/L, the result will also be scored acceptable because the amount found is less than the PTRL. However, as a general guideline, results less than the PTRL should not be reported.

PTP are not required to verify the presence of an analyte below ½ the PTRL.

4.15 Stop Work After Repeat PT Failure