NWS_2019_Analytical_Services_Contract_20190612.pdf

PERFORMANCE WORK STATEMENT

U.S. ARMY CORPS OF ENGINEERS

Seattle District

ANALYTICAL & DATA VALIDATION SERVICES FOR

ENVIRONMENTAL SAMPLE ANALYSIS

7 JUNE 2019

12 JUNE 2019

USACE Contact Information Physical Address: 4735 East Marginal Way South

Seattle, WA 98134-2329 Mailing Address: P.O.B. 3755

Seattle, WA 98124-3755

TABLE OF CONTENTS

Contents

1 CONTRACT DESCRIPTION

1.1 Introduction

1.2 DESCRIPTION OF WORK

1.3 OBJECTIVE

2 REQUIREMENTS

2.1 DoD ELAP and State Accreditations/Certifications

2.2 Compliance with the Department of Defense Quality Systems Manual (QSM)

2.2.1 Other Regulations

2.3 Detection Limit Studies

2.4 Availability of Results from Laboratory Information System

2.5 Services

2.5.1 Hazardous and Toxic Waste Analyses

2.5.2 Substances

2.5.3 Water

2.5.4 Per-and Polyfluorinated Alkyl Substances (PFAS)

2.5.5 Turnaround Time

2.6 Data Validation

2.6.1 Inputs and Outputs of Data Validation

3 SECTION 3 LABORATORY RESPONSIBILITY

3.1 Contract Modifications .................................................................. Error! Bookmark not defined.12

3.2 Sample Shipping Deficiencies

3.3 Sample Container and Shipment Services

3.4 Sample Receipt and Chain-of-Custody

3.5 Analytical Holding Times

3.6 Hazardous Materials Management and Laboratory Safety

3.7 Release of Information

3.8 Subcontracting

3.9 Liaisons

3.9.1 Contractor Liaison

3.9.2 Government Liaison

3.10 Quality Assurance Surveillance Plan (QASP )

3.11 Three-Phase Quality Control Reviews

4 SECTION 4 NON-CONFORMANCE TO CONTRACT

4.1 Precision/Bias, Accuracy, Representativeness, Completeness, Comparability and Sensitivity ... 15

4.2 Deliverables

4.3 Rejection of Data

4.4 Regulatory and Statutory Compliance

5 SECTION 5 DELIVERABLES

5.1 Data Reports

5.1.1 Preliminary Data

5.1.2 Summary Data Packages (“Stage 2a”)

5.1.3 Raw Data Package (“Stage 4”)

5.1.4 Non-Routine Analysis

5.2 Electronic Data Deliverables (EDDs)

5.2.3 SEDD 2a (or later)

5.2.3 ADR Files

5.2.4 Excel Files

6 SECTION 6 INVOICING

Attachment 1 Test Descriptions and Methods Attachment 2 Definitions & Acronyms Attachment 3 (A,B) Non-Conformance Reporting Attachment 4 Adobe® Deliverable Requirements Attachment 5 CHEMISTRY SUPPLEMENT Attachment 6 Data Validation Report Format

1 CONTRACT DESCRIPTION

1.1 Introduction

This contract will be a firm fixed price “Single Award Task Order Contract” (SATOC), with a base period and four one year option periods.

1.2 DESCRIPTION OF WORK

In executing investigation and remediation of hazardous and toxic waste projects, navigational and dredging projects, the U.S. Army Corps of Engineers (USACE), Seattle District (NWS) has need for an analytical laboratory to provide chemical analysis of the following matrices:

Soil Water Sediment Air Biota Chemical products Solid materials

This SATOC will be in support of work assigned to USACE, NWS for hazardous, toxic and radioactive waste (HTRW) remediation projects for both civilian and military agencies of the Federal Government. Samples are anticipated to be submitted from, but not limited to, the states of Washington, Oregon, Idaho, Montana, and California. The average task order will require the Offeror to have the capability to receive (but is not limited to) 10 or more samples a day for 7 or more contiguous days. During high workload events, the Government will engage in increased communication to ensure proper task order/project success. This contract is for environmental laboratory analysis and data validation associated with activities mandated by the Defense Environmental Restoration Program (DERP), Superfund, Brownfields, Formerly Utilized Defense Sites (FUDS), environmental cleanup activities under the Base Realignment and Closure (BRAC) Program, for its Army and Air Force customers, Department of Homeland Security and the Federal Emergency Management Agency (FEMA), and other environmental and homeland security laws and regulations requiring support activities for military installations, USACE civil works projects, and work for other agencies.

Other environmental laws and regulations governing environmental laboratory analysis and data validation include, but are not limited to, the Federal and state versions of the Clean Air Act; the Clean Water Act; the Toxic Substances Control Act (TSCA); the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA); the Resource Conservation and Recovery Act (RCRA); Underground Storage Tank (UST) regulations; and Section 515(a) of PL 106-554 (the Data Integrity Act) as implemented by OSD memorandum, Ensuring Quality Information Disseminated to the Public by the Department of Defense, February, 2003.

1.3 OBJECTIVE

The objective of this contract is to: 1) obtain chemical data that is technically valid, of known quality, and legally defensible, that will meet and/or exceed both overall and project-specific Data Quality Objectives (DQOs) for each task order; and 2) assess the chemical data’s quality by an independent third party, known henceforth as the data validation contractor, by the performance of full data verification and validation against criteria established within the analytical method, the Department of Defense Quality Systems Manual (DoD QSM), any task order specific DQOs, and as documented in the UFP-QAPP. Analytical test methods specific to this contract are located in Attachment 1.

2 REQUIREMENTS

The Contractor shall provide all labor, materials, tools, supplies, equipment, transportation, and services to accomplish the task order objectives in accordance with the base contract and respective task order requirements. The Contractor shall provide professional scientific and technical services to perform bioassay, chemical analysis and physical testing for the matrices specified in Section

1.2. The Contractor shall perform and assume all responsibility for the precision, accuracy, completeness, comparability and sensitivity of the analysis including assessing the data’s quality by the data validation contractor performance of full data verification and validation. The term of this contract will be from date of award through a period not to exceed five (5) years; one (1) base year and four (4) one year option periods.

2.1 DoD ELAP and State Accreditations/Certifications

The Contractor shall maintain DoD ELAP accreditation for each method specified in the QSM and in accordance with this PWS. Within ten (10) business days of contract award, the Contractor shall provide a copy of the current DoD ELAP certificates for each method. Certificates must clearly indicate both the fields of testing including scope of accreditation, and expiration date. The Contractor shall immediately notify the Government and furnish a copy of the DoD ELAP certification to the Project Chemist and COR when using a new or different subcontractor to execute a method under this PWS. Loss of accredited status, at any time during the term of the contract, may result in termination of the contract. The Government will verify DoD ELAP certification prior to award of each task order and option year. The Contractor is permitted five (5) business days to correct any deficiencies in accreditation status when notified by the Government.

Necessary state accreditations will be specified in task orders. The Contractor will be required to furnish a copy of the state accreditations prior to issuance of a task order.

2.2 Compliance with the Department of Defense Quality Systems Manual

(QSM)

USACE may use environmental data to accomplish one or more of the following:

Determine whether a chemical substance is present in an environmental sample at or above some threshold value or action level;

Verify that a pollutant concentration remains below a permit limit;

Evaluate potential risks to human health or the environment;

Monitor changes in concentrations of contaminants; or Determine the effectiveness of remediation activities.

Contractor shall comply with the technical requirements addressed in the current version of the DoD QSM at time of task order performance. The Government will clearly state within a task order any deviation from DoD QSM. If there is a conflict between the DoD QSM or the method, and the task order, the task order shall take precedence for the execution of work under that task order only.

2.2.1 Other Regulations

The Contractor and all of its subcontractors utilized under this contract shall adhere to all applicable federal and state worker safety regulations.

2.3 Detection Limit Studies

The Contractor must be able to achieve the reporting limit, detection limit, and practical quantitation limit (PQL), if warranted, for all analyses listed under this contract. Depending on the project/task order, one or more of the following Federal or State criteria may apply:

Federal/State drinking water standards or maximum contaminant levels (MCLs);

Washington State Model Toxics Control Act (MTCA);

Groundwater and surface water quality standards;

Toxicity Characteristic Leaching Procedure (TCLP) criteria;

Residential and non-residential soil cleanup standards;

Sediment quality standards.

The Contractor must be able to meet the applicable regulatory criteria governing environmental sampling analysis. USACE shall supply these criteria in the specific scope of work for each task order; along with required reporting limits required to satisfy the specific data quality objectives per task order.

2.4 Availability of Results from Laboratory Information System The Contractor shall be capable of providing results in electronic format directly from the Laboratory Information Management System (LIMS) as opposed to manual entry. The Government will furnish the parameters for which data results can be generated from the LIMS, as well as parameters for which data results cannot be generated from LIMS where manual entry is required.

The Contractor shall be capable of providing results in Staged Electronic Data Deliverable (SEDD) up to Stage 3, ADR A1/A3, Adobe® and/or Excel files as specified in Section 5.

2.5 Services

2.5.1 Hazardous and Toxic Waste Analyses

As stated in Section 1.3, analytical test methods specific to this contract are located in Attachment

1. The laboratory procedures including the required QA/QC of the approved test methods are based in part on the following references:

SW-846, 3rd Edition, Update V (or most current version) (https://www.epa.gov/hw-sw846/federal-register-notices-related-sw-846)

EPA Approved Drinking Water Methods (https://www.epa.gov/dwanalyticalmethods/approved-drinking-water-analytical-methods)

Washington Department of Ecology “Analytical Methods for Petroleum Hydrocarbons” (Publication No. ECY 97-602, June 1997 or most current version) (https://fortress.wa.gov/ecy/publications/summarypages/97602.html)

California State “Leaking Underground Fuel Tank (LUFT) Manual” (most current version) (https://www.waterboards.ca.gov/ust/luft_manual.html)

Compendium of Methods for the Determination of Toxic Organic Compounds in Ambient Air, EPA/625/R-96/010b (most current version) (https://www.epa.gov/pcbs/compendium-methods-determination-toxic-organic-compounds-ambient-air)

Montana Risk-Based Corrective Action Guidance for Petroleum Release (https://deq.mt.gov/Portals/112/Land/StateSuperfund/Documents/rbca/rbca_guid e.pdf)

Additional testing may be required using other EPA and ASTM methods. These procedures will be updated as necessary to reflect changed regulatory testing requirements in RCRA, CERCLA and other programs.

2.5.2 Substances

Toxic substances include asbestos, lead, and polychlorinated biphenyls (PCBs) in building materials. The Contractor and/or its subcontractors shall have NVLAP certification for asbestos analysis as required in 40 CFR 763. DoD ELAP accreditation is appropriate for lead and PCB requirements under this program.

2.5.3 Water

Water analytical support includes drinking water, storm water and waste water. For drinking water analyses, the Contractor and/or its subcontractors shall have Washington State Department of Health (DOH) certification or other state drinking water certification. For National Pollutant Discharge Elimination System (NPDES) compliance, approved analytical test procedures are listed under 40 CFR 136 or are specified in the specific discharge permit and the laboratory must be certified by the EPA.

2.5.4 Per-and Polyfluorinated Alkyl Substances (PFAS)

The Contractor shall have DoD-ELAP certification for EPA Method 537.1 (drinking water analysis); currently, this is the only EPA-approved method for PFAS analysis. Multiple new methods are expected for release in 2019, and potentially 2020, for PFAS analysis in different media. EPA has announced the following PFAS methods are currently in development

SW-846 Method 8327 (non-drinking water analysis) SW-846 Method 8328 (solids analysis) ASTM D7968 (soil analysis) Method 537.1 update (adding 4 PFAS compounds to EPA 537.1) New EPA method (not currently numbered/named) to analyze short-chain PFAS in drinking water not currently included in EPA method 537.1.

2.5.5 Turnaround Time

The Contractor shall be capable of providing routine and expedited chemical and material analysis for a comprehensive list of parameters routinely required by the Government:

Routine turn-around time shall be 21 calendar days;

Expedited turn-around-times shall be provided for 24 hour, 72 hour, and 7 day preliminary data;

Exceptions are made for isotope dilution methods which shall have standard turn-around- time of 40 days and an expedited turn-around time of 20 days.

Each task order will prescribe the required turnaround time.

2.6 Data Validation

The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform chemical data validation as defined in this PWS and shown in Attachment 6. The Contractor shall perform to the standards in this contract.

The Contractor shall provide data validation for the analyses shown in the price schedule. The Contractor shall provide all services necessary to provide a complete and accurate Data Validation Report (DVR), validated Electronica Data Deliverables (EDDs), EQuIS™ uploadable deliverables, and all project records electronically to USACE.

Data verification and validation shall be performed in accordance with the eQAPP and the principles of the US EPA National Functional Guidelines (NFGs). The Contractor shall document variances to assist USACE in determining consistency with project-specific data quality objectives.

In addition to primary sample data, field duplicates, trip blanks, rinsate samples, equipment blanks (if applicable), performance evaluation samples (if applicable), shall be reviewed and incorporated.

The standard ADR list (biased or unbiased) data qualifiers and reason codes shall be utilized.

Project EDDs incorporating data validation qualifiers, reason codes, and validation stages shall be created by the Contractor in a format which can be electronically loaded by the Government without further manipulation into the EQuIS™ data management software. Any data validation qualifiers applied as a result of the Contractor’s judgment shall be clearly indicated and electronically tagged as such, utilizing a means that is auditable within ADR.

Each analyte or parameter shall be labeled with the appropriate data validation stage in accordance with Guidance for Labeling Externally Validated Laboratory Analytical Data for Superfund Use, Appendix B (EPA, 2009). The labels shall be appended for each sample and method in the electronic outputs. In the A1/A3 file, this code is stored within the “QC Level” field. This information within EQuIS™ is in the “DT Test” table in the “QC Level” column. The valid values utilized for data validation shall be consistent with the Seattle District reference values set for EQuIS . The reference values and format shall be checked utilizing the EDP. The reference values and the EDP are available at: http://www.earthsoft.com/products/edp/edp-format-for-usace-seattle/.

If additional reference values are needed to complete the work, the Contractor shall notify the Seattle District project Chemist and COR immediately to coordinate the addition of values.

The DVR(s) shall provide a written narrative which summarizes findings for each method. The only method analytes which are to be verified and validation are those listed in the eQAPP. The DVR shall include the following: field and laboratory quality control practices employed in execution of the contract; a discussion of all data points which may have been compromised and their impact on the data quality objectives; a summary in terms of precision, accuracy, representativeness, completeness, and comparability (PARCCS) parameters; and any applicable data review reports. The format for DVR is presented in Attachment 6.

DVRs shall be provided within 60 days after the data validation contractor receives after the data package. The Contractor shall address and correct Government comments as needed. The DVR is final once accepted by the Government. DVRs shall be submitted in both native format and pdf format for review by USACE.

For the purposes of this contract, the term “data validation” is an analyte- and sample-specific process that extends the evaluation of data beyond method, procedural, or contractual compliance, (i.e., data verification) to determine the analytical quality of a specific data set.

Data validation criteria shall be based upon the measurement quality objectives developed in the QAPP or similar planning documents, or presented in the sampling or approved analytical method.

o Measurement Quality Objectives are “acceptance criteria” for quality attributes measured by project DQIs.

o During project planning, MQOs are established as quantitative measures of performance against selected DQIs, such as: precision, bias, representativeness, completeness, comparability, and sensitivity.

Data validation includes a determination, where possible, of the reasons for any failure to meet method, procedural, or contractual requirements, and an evaluation of the impact of such failure on the overall data set.

Data validation applies to activities in the field as well as in the analytical laboratory.

All data validation shall be completed by an independent third party (data validation contractor) not responsible for performing any analytical services for the Contractor under this contract. USACE has determined that the appropriate degree of independence as follows: the validator shall not belong to the same business entity, to include any affiliated companies, with immediate responsibility for producing the data set.

The Contractor shall make all planning documents and procedures readily available to the subcontractor performing the data validations.

The Contractor shall clearly communicate the specific project or task order needs with the data validation contractor.

The task order requirements should assist in defining the appropriate personnel to perform the data validation.

The subcontractor performing data validation shall also be familiar with the task order or project-specific DQIs and associated measurement quality objectives. One of the goals of the data validation process is to evaluate whether the data quality goals established by the task order, during the planning phase, have been achieved. To achieve this, data quality attributes shall be defined and measured.

DQIs- such as precision, bias, comparability, sensitivity, representativeness, and completeness shall be used as expressions of the quality of the data.

2.6.1 Inputs and Outputs of Data Validation

The inputs to data validation, the data validation process, and the outputs of data validation shall be described in each data validation report. The level of data validation performed shall be specific to each task order.

The Contractor shall identify the records that are produced, and determine the criteria or specifications against which the records shall be compared. Such criteria or specifications may be located or described in any of the documents:

project-specific planning documents for a given task order;

o The Government shall verify that project-specific planning documents include a

QAPP or equivalent document.

program-wide planning documents (e.g., Quality Management Plan);

SOPs, including field and laboratory methods; or published, approved sampling or analytical methods such as SW846 methods or American Society for Testing and Materials protocols].

As the data collection effort progresses from sample collection through sample analysis, the field and laboratory personnel produce a series of records that can be verified. These records may be verified at each sequential step and/or during the final record review process. The Contractor shall submit the verified data to the data validation contractor to perform data validation.

Project-Specific Planning Documents Inputs from Field Activities Inputs from the Analytical Laboratory Implement of Data Validation. At a minimum, the following three steps of data validation shall include:

o Identify the project needs for records;

o Obtain the records that were produced during data verification; and o Validate the appropriate records to determine the quality of data and whether or not project needs were met by performing data validation and focused data validation, as requested.

The data validation contractor shall perform Data Validation of Field Activities and well as Data Validation of Analytical Laboratory Activities:

Using the planning documents related to sample analysis, the data validation contractor must be able to comprehend the project requirements that the analytical laboratory was expected to meet.

The data validation contractor shall be able to answer questions such as: Was a particular analytical method specified for any analyses? Was a specific reporting limit specified for any particular chemical?

The Contractor must submit planning document specifications, based on questions similar to these, help the data validation contractor focus on the appropriate information during the data validation of the verified data and associated records.

The DVR shall summarize the data validation in such a way that the Government can get a general overview of the data validation before using the data.

“Outputs of Data Validation”, at a minimum, the data validation contractor must have two outputs from data validation: validated data and a data validation report.

Validated data shall be the same as the verified data with the addition of any data validation qualifiers that were assigned by the data validation contractor. Any corrections or changes noted during the data validator’s review of the verified data shall be reflected in the validated data.

3 SECTION 3 LABORATORY RESPONSIBILITY

3.1 Sample Shipping Deficiencies

The Contractor shall notify the Government via email and telephone immediately of all sample deficiencies noted upon arrival at the receiving laboratory.

The Contract laboratory shall be held accountable for any sample deficiencies noted upon arrival at subcontract laboratories, such as broken or leaking sample containers, elevated sample cooler temperatures, broken custody seals, etc. The Contractor shall immediately notify the Government by both telephone and email concerning such deficiencies in order to obtain guidance regarding the appropriate required action.

3.2 Sample Container and Shipment Services

The Government is responsible for collecting all samples under this contract and will ship the samples to the analyzing laboratory as specified by the Contractor. The Contractor shall provide the Government with individual certified-clean sample containers (preserved and unpreserved), materials (chain-of-custody forms/sample analysis requests, self- sealing bags, custody seals, labels, etc.), and bulk shipping containers (coolers) as needed to prepare the samples for shipment to the receiving laboratory. Sufficient information will be provided to the Government to identify which containers, and minimum or maximum sample volumes are required for each analysis. In cases where extra sample volume is required for project completion, this requirement shall be clearly specified in the task order or project specific statement of work. The Contractor shall be responsible for all costs associated with the shipment of sample containers and materials to the field prior to sample collection. The Contractor shall be responsible for the shipment and costs associated with shipment of samples to subcontracted laboratories, as applicable. The Contractor shall be responsible for providing instructions regarding the packaging of samples in accordance with current Federal, Department of Transportation, and Homeland Security guidance. The Contractor shall assume that all sample shipments to subcontracted laboratories will require overnight delivery.

3.3 Sample Receipt and Chain-of-Custody

All sample receipt and chain-of custody forms shall be completed and emailed back to the Project Chemist and COR immediately upon completion of login at the receiving laboratory.

3.4 Analytical Holding Times

The Contractor shall notify the Government via email and telephone immediately if holding times cannot be met. The Contractor shall be held accountable for samples analyzed outside of specified holding times for the analyses. The Government will determine whether re-analysis will occur based on task order objectives. If re-analysis occurs, the Contractor will re-analyze at no additional costs to the Government.

3.5 Hazardous Materials Management and Laboratory Safety

The Contractor shall be responsible for the management and disposal of all samples and containers received by the laboratory or return to the laboratory under this contract. The Contractor shall employ personnel with sufficient training, certification, and/or registration to perform required tasks in accordance with all applicable laws and regulations.

The Contractor shall ensure the laboratory is operated in a safe manner and compliant with all applicable laws and regulations including the OSHA laboratory standard. The Contractor shall have and maintain a Chemical Hygiene Plan for the primary laboratory and all subcontracted laboratories.

3.6 Release of Information

Information and data concerning work shall not be discussed or released in any form to any party without the express consent of the Government. Inquiries shall be directed to the Contracting Officer, Contracting Officer Representative (COR) and the Government Project Manager.

3.7 Subcontracting

In accordance with the DoD QSM, the Contractor shall ensure that each subcontracted laboratory meets the requirements of the DoD QSM. All subcontracted laboratories must be accredited by DoD or its designated representatives. The Government shall be notified in advance of any analysis performed by subcontracted laboratories for each task order. These requirements also apply to the use of laboratories under the same corporate umbrella, but at a different facility or location.

Subcontracted laboratories shall be given a copy of the approved Quality Assurance Project Plan (QAPP). Project specific laboratory quality assurance and quality control (QA/QC) requirements contained in the approved QAPP shall supersede any generic requirements identified in the DoD

QSM.

Laboratory QA/QC shall be implemented and maintained as described in the QAPP and according to the laboratories’ QA plans and Standard Operating Procedures (SOPs). The Contractor’s laboratories’ performance shall be checked through the use of performance evaluation (PE) samples. Audit reports, including but not limited to Navy and/or Air Force formats may be requested from the Contractor.

The Contractor shall ensure the Government is notified in writing of any changes in laboratory certification or accreditation status within 3 business days of the change. This written notification requirement applies, but is not limited to, suspension or revocation of certification or accreditation.

3.8 Liaisons

In order to foster and maintain successful communications the following liaisons shall be established:

3.9.1 Contractor Liaison

The Contractor shall assign a principal employee or Contract Representative to serve as the liaison to the Government for this contract. The liaison shall oversee the coordination of the entire contract and shall be capable of administering all instructions from the Government and obtaining answers to all questions from the Government during the life of this contract.

3.9.2 Government Liaison

Technical direction and coordination for task orders shall be provided by the Contracting Officer’s Representative (COR) and/or Government Project Chemist. Contractual direction shall be provided by the designated Contracting Officer or Contracting Officer’s Representative (COR).

3.9 Quality Assurance Surveillance Plan (QASP )

The Government will evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

3.10 Three-Phase Quality Control Reviews

At any time during the life of this contract, the Government may perform three-phase quality control reviews during execution of each task order. At the request of the Government, the Contractor shall participate in three-phase quality control meetings including the following:

• Readiness Review - Readiness Reviews are typically conducted before proceeding with each Task Order. The Contractor shall be required to review each task order and determine if errors are present and whether they can complete the work as designated by the Government.

Participation in the Readiness Review shall be mandatory.

• Initial Review – This review shall be accomplished at the beginning of execution of a task order. The Initial Review shall verify that control for the work developed in the “Readiness Review” has been implemented and the work will be performed in accordance with site specific task order Requirements. Contractor participation in the Initial Review shall be at the request of the Government.

• Follow-up Review - Periodic checks shall be performed by the Government to ensure continuing compliance with contract requirements. Final follow-up checks shall be conducted and all deficiencies corrected prior to the start of additional features of work.

Contractor participation in the Follow-up Review shall be mandatory.

Reviews may will primarily be conducted via email or telephonically. The Government reserves the right to conduct the reviews in person, at the laboratory. The Government shall document the Reviews; both parties shall be required to review and sign the documentation once an agreement is reached.

On-Site Audits At any time, representatives of the Contracting Officer may review the progress and technical adequacy of the work being performed, including conducting on-site audits. Such audits shall not relieve the laboratory from performing all contract requirements.

4 SECTION 4 NON-CONFORMANCE TO CONTRACT

The DoD QSM provides basic requirements for the establishment and management of quality systems for laboratories performing analytical testing services for the DoD under this contract.

Other project-specific requirements shall be specified per specific task order. The Contractor shall be solely responsible for performing work in accordance with the contract and task orders.

Should the Government identify an event which appears to signify a failure on the part of the Contractor to execute the task in accordance with the specific requirements of this contract, a non-conformance investigation shall be promptly initiated by the Contractor. The Contractor and the Government shall prepare a “Non-Conformance Report” (NCR) to address the situation (Attachment 3A). All work required in performing a non-conformance investigation including preparation of a “Corrective Action Plan”’ (CAP) (Attachment 3B) and any required support documentation shall be executed at no additional expense to the Government.

A non-conformance investigation must include submission of: 1) a corrective action plan to resolve the problem; and 2) a report of findings within five (5) business days of notification of the deficiency by the Contracting Officer. The corrective action plan and report of findings shall substantively address the deficiencies described by the Contracting Officer. Any corrective actions shall be implemented within five (5) business days of direction by the Contracting Officer. The Contracting Officer shall determine the acceptability of the CAP and report of findings; an additional investigation may be required if the initial response is unacceptable to the Government.

All corrective action plans must be supported by the appropriate documentation as determined by the Government. The Government may require additional raw data packages to support the analysis in the CAP. This data shall be delivered at no additional cost to the Government. In the event that the Contractor is found to be non-responsive to contract requirements this contract may be terminated for default.

In cases where a nonconformance justifies a comprehensive on-site “electronic audit” as determined by the Government, access to laboratory facilities and laboratory staff shall be provided at no additional expense to the Government. This includes access to laboratory staff required to operate instruments or reprocess data in the presence of Government auditors.

4.1 Precision/Bias, Accuracy, Representativeness, Completeness, Comparability and Sensitivity The Contractor shall perform and assume all responsibility for the precision/bias, accuracy, completeness, comparability and sensitivity of their work and services. Matrix effects that are beyond the control of the laboratory are excluded from this requirement. Establishment of matrix effects shall be the burden of the Contractor using corrective action criteria established in the DoD QSM such as comparison of MS/ MSD results to LSC recoveries, comparison of internal standard recoveries in field samples to QC results, use of post digestion spikes, and dilution tests. The case narrative of the laboratory report must provide a technical justification for asserting matrix effects as opposed to laboratory error.

The definition of “quality” for purposes of this contract includes the appropriateness, timelines, and thoroughness of corrective actions identified by the Contractor, as described in the DoD QSM and described below:

Precision, Bias and Accuracy - All data shall fall within the control limits for precision/ bias and accuracy as described in the DoD QSM and project-specific task order.

Representativeness – Sample representativeness shall be ensured as specified in the DoD QSM through appropriate subsampling procedures for all samples. Instructions for handling multiphase and heterogeneous samples shall be included in project specific task orders.

Completeness - Completeness of data must be greater than or equal to ninety-five (95%) percent. Completeness is defined according the following formula:

Comparability - Comparability of the data shall be ensured through the use of uniform sampling sample handling procedures, standard methods of analysis, and standard quantitation limits.

Sensitivity – The limits of quantitation (LOQ) and limits of detection (LOD) as defined by the

DoD QSM shall meet all project-specific task order requirements. The DoD QSM requires that laboratories verify measures of method sensitivity, in terms of the LOD and LOQ, at least quarterly. Requirements for the LOD and the LOQ are contained in DoD QSM Boxes D-13 and D-14, respectively.

Results judged to be non-compliant as a result of proven matrix effects or insufficient sample volume shall not apply in the above calculation.

In addition to the requirements outlined in this Section, the Contractor shall implement the requirements listed in Attachment 5; entitled “Chemistry Supplement to the Scope of Services”.

4.2 Deliverables

Data packages are due within time frames specified in the specific Task Order. When accelerated turn-around-time has been requested and the data is delivered outside of this requested date, payment will be reduced to correspond to the applicable payment for the actual delivery of data.

For example, if a 24 hour turn-around-time has been contracted for and the data is instead delivered within 21 days, which corresponds with a normal turn-around time, payment for normal turn-around-time instead of the 24-hour turn-around-time shall be made. See Section 5 for deliverables.

4.3 Rejection of Data

Contract Completeness = 100% #contract compliant results #results reported

Data will be screened for both contract and QA/QC compliance by the Project Chemist and COR.

Failure to execute specific actions required by this contract will result in rejection of data for the corresponding samples.

Failure to execute analytical methods as stated in the approved task order will result in rejection of data.

Failure to deliver analytical data in the format specified in the approved task order will result in rejection of the data packages and direction by the Contracting Officer to reissue data deliverables in full compliance with these specifications. This work will be performed at no additional expense to the Government.

At a minimum, payment may be denied for analytical work that is rejected for contract compliance failure. The Government may reject results for missed holding times, improperly calibrated laboratory equipment, or inaccurate quality control not attributable to cross contamination due to field and/or sample collection, or insufficient sample volume. Alternatively, the Contracting Officer may require re-sampling and reanalysis at the expense of the Contractor. If this occurs, the Contractor shall reimburse USACE for the full cost of re-sampling performed by USACE personnel or by USACE Contractor personnel as applicable. Reimbursement could include Government effort to mobilize, resample, and all costs for shipping, analysis and reporting.

4.4 Regulatory and Statutory Compliance

All aspects of work performed under this contract are to meet all applicable or relevant and appropriate Federal, State and local regulations. Compliance with these regulations shall be the responsibility of the Contractor. Failure to comply with regulatory standards may results in a claim by the Government.

5 SECTION 5 DELIVERABLES

For the purposes of the Contract, the most recent version of the DoD QSM requirements shall constitute the basic deliverable. The general requirements for laboratory deliverables are described in the DoD QSM Section 5.10. However, the requirements of project-specific Task Orders and QAPP supersede the requirements of the QSM. Deliverables which shall be provided under this Contract include the following:

• Data Reports Summary data packages Raw data packages Non-Routine Services Adobe® files (electronic versions of hardcopy data reports)

• Electronic Data Deliverables (EDDs)

SEDD files ADR files Excel® files

The Contractor shall assemble the data and submit it in hard copy and electronic format. A “zip” file transmitted via the internet may also be required at no additional cost to the Government. The Contractor shall maintain all data associated with the analyzed samples electronically for a period of three years.

Deliverables shall be specified in the task order. The detailed requirements for the task order include location, schedule, point of contacts, schedule, analytical methods, sample quantities, technical criteria and deliverables that are needed. No work shall be performed prior to award of a task order.

5.1 Data Reports

The Contractor shall be responsible for assembling a general data report which includes, but is not limited to, discussions, tables, and charts detailing the condition of the samples when received by the lab, the results of the samples once analyzed, and quality control documentation used to address the quality of the data generated by the performing laboratories. Reference to deliverable “Stages” are as defines in the most recent version of EPA 540-R-08-005). Adobe® versions of the Data Report shall be provided for all Task Orders. The technical specifications for Adobe® files are located in Attachment 4. The cost of Adobe® deliverables shall be included in the unit cost for analyses.

The data deliverable shall conform to the description below:

5.1.1 Preliminary Data

Some projects may require preliminary deliverables consisting of data that has not yet gone through the normal process of being reviewed by the laboratory. For these projects the following minimum information shall be included in the deliverable:

Project Name Field Sample ID Lab Sample ID Matrix Date Collected

Date Received Date Prepared Date Analyzed Method Results (including CAS Number) Concentration Units Lab Qualifier

The cost for preliminary deliverables shall be included in the unit cost for analyses. Deliverable (Excel® or hardcopy) format will be specified in individual Task Orders.

5.1.2 Summary Data Packages (“Stage 2a”)

The summary data package format allows for the review of the data by an independent organization.

However, this data package does not allow for complete independent reconstruction of the analytical data. As discussed in more detail in the following sections, the summary data package shall include a cover sheet, table of contents, case narrative, the analytical results, laboratory reporting limits, sample management records, and internal laboratory QA/QC information. The Summary Data Package shall be organized such that the analytical results are reported on a per-batch basis unless otherwise specified.

Cover sheet

The cover sheet shall specify the following information:

Title of report.

Name and location of Contractor (to include a point of contact, phone, email and facsimile numbers).

Name and location of any subcontractor laboratories, and appropriate test method performed.

Contract number and Task Order number.

Client name and address.

Project name (as provided on Task Order), and site location.

Statement of data authenticity and official signature and title of person authorizing report release.

Amendments to previously released reports shall clearly identify the serial number for the previous report and state the reason(s) for reissuance of the report.

• Table of Contents

Contractor data packages shall be organized in a format that allows for easy identification and retrieval of information. An index or table of contents shall be included for this purpose.

Electronic deliverable shall also have a hyperlinked Table of Contents.

• Case narrative

A case narrative shall be included in each report. The case narrative shall contain a table(s) summarizing samples received, providing a correlation between field sample numbers and laboratory sample numbers, and identifying which analytical test methods were performed and by which laboratories. Samples that were received but not analyzed shall also be identified.

Extractions or analyses that are performed out of holding times shall be appropriately noted.

The case narrative shall define all data qualifiers or flags used. Deviations of any calibration standards or QC sample results from appropriate acceptance limits shall be noted and associated corrective actions taken by the Contractor shall be raised and addressed. Any other factors that could affect the sample results (e.g., air bubbles in VOC sample vials, excess headspace in soil VOC containers, the presence of multiple phases, sample temperature and sample pH excursions, container type or volume, etc.) shall be noted. The USACE Task Order #, Project Name, Contract Laboratory Project Number (SDG) and Contract Laboratory Name will be included.

• Analytical Results The results for each sample shall contain the following information at a minimum.

(Information need not be repeated if noted elsewhere in the data package).

Contractor name and location (city and state);

Project name and unique ID number;

Field sample ID number as written on custody form;

Contract Laboratory sample ID number;

Matrix (soil, water, oil, etc.);

Sample description;

Sample preservation or condition at receipt;

Date sample collected;

Date sample received;

Date sample extracted or prepared;

Date sample analyzed;

Analysis time when holding time limit <48 hours;

Method (and SOP) numbers for all preparation, cleanup, and analysis procedures employed;

Preparation, analysis, and other batch numbers;

Analyte or parameter;

Method reporting limits adjusted for sample-specific factors (e.g., aliquot size, dilution/concentration factors, moisture content);

Method reporting limits (low-level standard concentration);

Method detection limits;

Analytical results with correct number of significant figures;

All confirmation data;

Any data qualifiers assigned;

Concentration units;

Dilution factors;

Percent moisture or percent solids (all soils, sediments, sludges, biota, etc. are to be reported on a dry weight basis);

Methods QC data (if the method is not included in the DoD QSM, laboratory or method QC shall apply)

Chromatograms (for pattern recognition analyses);

Sample Management Records

These types of records include the documentation accompanying the samples (i.e., original chain-of-custody record, shipping documents, laboratory notification sheets), records generated by the Contractor that detail the condition of the samples upon receipt at the laboratory (i.e., sample cooler receipt forms, any telephone conversation records, etc.), and any records generated to document sample custody, transfer, analysis, and disposal.

5.1.3 Raw Data Package (“Stage 4”)

A raw data package contains sufficient information to completely reconstruct the chemical analyses that were performed. Hence, raw data packages include all batch QC results, instrument QC results (e.g., initial calibration verification, continuing calibration verification, and instrument performance checks), MDL studies, and raw data (e.g., run logs, sample preparation logs, standard preparation logs, and printed instrumental output such as chromatograms). These requirements are described in the DoD QSM.

5.1.4 Non-Routine Analysis

The Contractor shall be capable of performing or subcontracting required work to meet the task order objectives for identification of unknowns and bioassays. Precision, accuracy, representativeness, completeness, comparability, and sensitivity (PARCCS) requirements for such analyses shall be agreed upon with the Government. The Contractor is responsible for assembling the results identification of unknowns into an acceptable raw data package.

5.2 Electronic Data Deliverables (EDDs)

All data shall be submitted to the Government electronically in conformance with one of the four formats described below. The cost for one EDD (SEDD, ADR, Excel® or WQX) shall be included in the total cost for analyses. Data deliverable formats required will be specified by the Government with each Task Order.

5.2.3 SEDD 2a (or later)

The Contractor shall provide the Government with an industry-standard Extensible Markup Language (XML) file utilizing the appropriate DTD. The Government will be responsible for submitting information necessary for the Contractor to develop a common structure and data dictionary. All SEDD files must pass checks as described below:

1) SEDD Tool

All SEDD files shall pass checks without defects.

For samples requiring dilution during analysis, only a single set of results shall be submitted in the SEDD deliverable. Analytes may be reported from different dilutions. The Contractor shall indicate the reportable result for each analyte. For example, reportable results are those greater than Reporting Limit or, should both results be non-detect, then the results associated with the most compliant quality control are reportable.

2) EQuIS™ Checks

All SEDD files shall pass EQuIS™ Data Processor (EDP) checks without any faults of type “Error.” Depending on their nature, EDP “Warnings” may be allowed at the discretion of the Government.

The EDP and Seattle District data dictionary are available under password protection at… http://www.earthsoft.com/products/edp/edp-format-for-usace-seattle/

3) ADR Checks

Laboratory SEDD files will also be checked using the laboratory version of ADR.NET.

Prior to importing the SEDD into the ADR software, the laboratory will verify that the SEDD Extensible Mark-up Language (XML) file conforms to all USEPA-approved document type definitions (DTDs). All fields must be completed according to the stage of the deliverable requested. The eQAPP (electronic Quality Assurance Project Plan) necessary to perform these checks will be supplied by the Government.

ADR checks the integrity of each SEDD by reviewing the file against the ADR Project Library requirements in the Contract Compliance Screen (CCS) module. Non-conformance reports (“EDD Error Logs” and “EDD Warning Logs”) are generated to identify items that do not comply. The laboratory will review these non-conformance reports and make any necessary changes to the SEDD files. This non-conformance review process is repeated until all non-conformances within the laboratories control are resolved.

Non-conformances that are not in the laboratories control are to be addressed by inserting a brief explanation in the “Warning Logs.” The final “Warning Logs” will be produced in portable document (PDF) and hard copy formats to be forwarded with the final SEDD files to the Government. All “Errors” shall be corrected prior to delivery to the Government.

Upon receipt of the SEDD files and non-conformance reports, the Government will run the ADR Contract Compliance Screening (CCS) Tool to generate their own non-conformance reports. The laboratory and Government generated non-conformance reports should be identical.