2027 Lab ISID RFP Attachment I Program Statement.pdf
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- Attached to
- 2027 Laboratory Testing Services ISID Contract
- Solicitation number
- RFP 171 270000000017 1
- Issued by
- Michigan
About this file
This is a Program Statement attachment for laboratory testing services contracted by the Michigan Department of Environment, Great Lakes, and Energy (EGLE), Remediation and Redevelopment Division. The document outlines comprehensive requirements for contracted laboratories providing analytical testing services to support EGLE's environmental remediation, redevelopment, and cleanup projects conducted under various federal, state, and local regulatory programs including Part 201 Environmental Remediation, Part 211 Underground Storage Tank Regulations, and Part 213 Leaking Underground Storage Tank regulations. The contracted laboratory must provide sample analysis, quality assurance project plans, chain of custody documentation, and analytical reports according to EGLE's Published List of Target Detection Limits and Designated Analytical Methods. Services encompass analyses for hazardous materials from known or suspected contaminated waste sites, with the contracted laboratory responsible for proper handling and legal disposal of hazardous waste materials.
The contracted laboratory must maintain service levels consistent with factors evaluated during contract award, comply with conflict of interest policies, and meet specified turnaround times and holding times for sample analysis. Key operational requirements include establishing a primary point of contact and emergency contact available 24/7, maintaining EGLE documents for a minimum of seven years, participating in annual proficiency testing for volatiles, semivolatiles, pesticides, PCBs, and metals analyses, and accepting unannounced audits by EGLE. The laboratory must provide electronic invoices in Excel format detailing project costs, accept sample pick-up responsibilities at EGLE facilities at no additional charge, retain samples for a minimum of 30 days after analysis completion, and subcontract or purchase services only from state-contracted laboratories or accredited providers with State Project Manager approval. EGLE reserves the right to determine project assignments, revoke assignments, and redirect work to alternative laboratories if proficiency testing results are unacceptable or deficiencies are identified during audits.
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ATTACHMENT I
PROGRAM STATEMENT
Remediation and Redevelopment Division
Michigan Department of Environment, Great Lakes, and Energy
MICHIGAN DEPARTMENT OF ENVIROMENT, GREAT LAKES, AND
ENERGY REMEDIATION AND REDEVELOPMENT DIVISION
PROGRAM STATEMENT
EGLE RRD REQUIREMENTS FOR CONTRACTED
LABORATORY TESTING SERVICES
DOCUMENTS INCLUDED BY REFERENCE
PUBLISHED LIST OF TARGET DETECTION LIMITS AND DESIGNATED
ANALYTICAL METHODS – EGLE REMEDIATION AND
REDEVELOPMENT DIVISION, MARCH 2016 - REVISED SEPT. 2026
TABLE OF CONTENTS
ACRONYMNS AND DEFINITIONS 3
1 PROGRAM BACKGROUND 3
2 PURPOSE 4
3 APPLICABLE REGULATORY PROGRAMS AND GUIDANCE 4
4 HAZARDOUS MATERIALS 4
5 PROJECT ASSIGNMENTS 4
6 MAINTENANCE OF FACTORS AND CONTRACT MODIFICATIONS 5
7 CONFLICT OF INTEREST 5
8 SUBCONTRACTED AND PURCHASED SERVICES 6
9 CHAIN OF CUSTODY (COC) DOCUMENTATION 7
10 QUALITY ASSURANCE PROJECT PLANS 8
11 DOCUMENTS AND RECORDS 8
12 EFFECTIVENESS AND DOCUMENTATION OF COMMUNICATIONS 9
13 CONTACTS 10
14 INVOICES 11
15 SAMPLE MANAGEMENT 12
16 ANALYSES 13
17 TURNAROUND TIME (TAT) 16
18 REPORTS 16
19 PROFICIENCY TESTING 18
20 STATISTICAL CONTROL OF METHOD PERFORMANCE 18
21 AUDITS 19
22 NEGOTIATION OF DISPUTES 19
ACRONYMNS AND DEFINITIONS
EGLE
RRD
EGLE Lab
NREPA
Contracted Laboratory Projects
QAPP
Site/facility/incident
Project Manager
State Project Manager
Michigan Department of Environment, Great Lakes, and Energy.
Remediation Redeveand lopment Division of EGLE.
Michigan Department of Environment, Great Lakes, and Energy, Laboratory Services located at 3350 N. Martin Luther King Jr. Blvd., Lansing MI, 48906-2933 or 7850 Crowner Dr., Dimondale MI, 48821.
Natural Resources and Environmental Protection Act, 1994 PA 451, as amended.
Contracted Laboratory Testing Services Contractor State funded projects conducted by the Michigan Department of Environment, Great Lakes, and Energy and all of its divisions to carry out its missions and objectives under a variety of federal, state, and local regulatory programs.
Quality Assurance Project Plan, a document with detailed information that can be used to ensure and verify the competence of the laboratories to provide quality data.
This refer s to an area where sampling events may take place, as identified by EGLE.
Project Manager in this document refers to the person who is responsible for arranging projects directly with the Contracted Laboratory and identified on the chain of custody as the contact which the Contracted Laboratory shall use for matters related to the completion of the project. This person may be employed by EGLE (State Project Manager) or employed by a company under contract to EGLE.
State Project Manager in this document refers to the person employed by EGLE and is responsible for oversight of projects conducted at specific sites of environmental contamination. This responsibility includes oversight of projects arranged by Project Managers working for a firm under contract to EGLE.
1 PROGRAM BACKGROUND
The mission of the Michigan Department of Environment, Great Lakes, and Energy is provided at Mission, Vision, and Values (michigan.gov). To fulfill that mission, EGLE conducts various cleanup projects to protect the public health, safety, welfare, and the environment through:
i) Regulated party cleanup: oversee and provide information to support cleanup of contaminated sites by parties responsible for causing contamination, initiating enforcement action when voluntary compliance cannot be achieved, and recovering State cleanup funds from liable parties.
ii) Site-funded actions: provide funding and oversight of State contractor actions to address sites that pose a risk to the public health or environment. Activities include providing alternative drinking water supplies, conducting groundwater/soil investigations and remediation, and removal of underground storage tanks and other hazardous substance containers.
iii) Preparing sites for redevelopment: providing actions to remediate contaminated sites to a level that allows the property to be redeveloped: Activities include overseeing contractors who conduct various demolition and cleanup activities, reviewing Baseline Environmental Assessments (BEAs) and Due Care work plans, and developing legal agreements that foster redevelopment and protect new owners and operators from liability for past releases they did not cause.
2 PURPOSE
The purpose of this program Statement is to provide the Contracted Laboratory a description of the program requirements relevant to the provision of Contracted laboratory Testing Services required by EGLE.
3 APPLICABLE REGULATORY PROGRAMS AND GUIDANCE
The Contracted Laboratory shall be knowledgeable of guidance applicable to laboratory services required by EGLE and provided in documents including but not limited to EGLE’s Published List of Target Detection Limits and Designated Analytical Methods, and other applicable regulatory programs within EGLE including:
• the Part 201, Environmental Remediation,
• the Part 211, Underground Storage Tank Regulations, and
• the Part 213, Leaking Underground Storage Tanks, of the Natural Resources and
Environmental Protection Act, Public Act 451, 1994, as amended (NREPA).
4 HAZARDOUS MATERIALS
The samples collected are frequently from known or suspected hazardous waste sites which may contain high levels of potentially hazardous substances. It is the Contracted Laboratory’s responsibility to take all necessary measures to ensure laboratory safety for the proper handling and legal disposal of any hazardous waste.
5 PROJECT ASSIGNMENTS
EGLE reserves the right to determine if any assignment it makes is in fact to be rendered, suspended, or revoked. The assignment of eligible Contracted Laboratories will be at the sole discretion of EGLE’s Project Managers and the extent to which an eligible Contracted Laboratory’s services may be used by EGLE, in total or in association with any assigned projects, sites, or element of work, will be at the sole discretion of EGLE’s Laboratory Services.
Notwithstanding any term or provision of any agreement to perform work for project(s), any contracts, accreditations, certifications, and recognitions by EGLE does not warrant or entitle the Contracted Laboratory to the assignment of any work whatsoever.
Upon acceptance of a project, the Contracted Laboratory warrants to EGLE that it has a full understanding of the requirements of this contract and the project-specific agreement and has the requisite competence and experience to perform the services as required.
6 MAINTENANCE OF FACTORS AND CONTRACT MODIFICATIONS
The Contracted Laboratory shall maintain its level of services based on the factors evaluated for awarding the contract. The Contracted Laboratory may at any time propose modifications which will improve on the level of services.
6.1 Maintaining Level of Services based on Factors Evaluated for the Contract
The Contracted Laboratory shall maintain the level of services which were the basis on which the contract was awarded. Factors on which the contract was awarded are provided in the initial questionnaire, the Request for Proposal, the Cost Proposal, and the contract.
6.2 Modifications of Services
The contract terms and conditions shall not be modified without written approval by the Department of Technology, Management and Budget. One very important factor is the maximum amount of the contract. The Contracted Laboratory shall periodically review its total amount paid under the contract and compare that to the maximum amount allowed. If the difference is less than $50,000, the Contracted Laboratory shall contact the Contract Administrator to discuss contract modifications.
7 CONFLICT OF INTEREST
A conflict of interest can exist when the Contracted Laboratory’s organization or its staff are influenced by undue internal and external pressures that adversely affect the quality of the work. Assignments may be made, revoked or continued with some contingencies based on discovery that conflicts of interest exist.
The Contracted Laboratory shall provide services free of actual and apparent conflicts of interest.
If at any time the Contracted Laboratory discovers its clients include any which are owners or operators of the site being investigated by EGLE, the Project Manager and State Project Manager shall be immediately informed.
Upon assignment or being made aware of a potential project, the Contracted Laboratory shall:
Review information provided by the Project Manager in an attempt to discover if the Contracted Laboratory, its parent company and subsidiaries have a vested interest in the outcome of findings, such as if they are owners and/or operators of the site being investigated.
Conduct such reviews as necessary in an attempt to determine if its employees with responsibilities for the samples have an actual or possible interest in the outcome of the results; for example, if the employee or their relatives are the owner or operator of a site being investigated.
Employee and staff reviews may be eliminated if the Contracted Laboratory has a process which ensures sample origin identifiable information is hidden from its staff.
Review current projects to determine if they are from the same site being investigated by the EGLE.
The Contracted Laboratory shall report discoveries to the Project Manager and State Project Manager.
8 SUBCONTRACTED AND PURCHASED SERVICES
Subcontract services are services within the capabilities of the Contracted Laboratory which are obtained by the Contracted Laboratory through agreements with other laboratories.
Purchased services are those services obtained by the Contracted Laboratory and outside the capabilities of the Contracted Laboratory.
8.1 Laboratory Contact for Purchased Services
The Contracted Laboratory shall provide a primary point of contact (See section Project Management below) that has the expertise to purchase services that cannot be obtained through EGLE and contract labs.
Tasks that may be required include:
Reviewing project specifications with the Project Manager.
Identifying candidate laboratories.
Providing requirements to the candidate laboratories.
Soliciting costs, if necessary.
Selecting the laboratory.
Taking ownership of deliverables.
Arranging for payments.
The tasks required prior to and during selection of the laboratory are waived when EGLE chooses to select the laboratory for purchased services.
The Contracted Laboratory may charge the actual invoiced costs from the laboratory whose services were purchased.
Laboratories submitting a proposal for considering under this Program Statement may not be included in any other proposal as a subcontracted laboratory or provider of purchased services.
8.2 Laboratory Selection for Subcontracted and Purchased Services The Contracted Laboratory shall subcontract and/or purchase services using the following hierarchy of selection listed below:
1. Laboratories under contract to the State.
2. Laboratories with accreditation or certification credentials for the analyses and parameters required.
8.3 Approval of Laboratory Selection
The selection of laboratories must be approved by the State Project Manager, unless time critical subcontracted services dictate immediate actions be taken. Approvals provided through verbal communications must be documented by email or other written means.
8.4 Subcontracted Services Required to Meet Agreed-To Obligations Once an assignment is made and accepted by the Contracted Laboratory, the Contracted Laboratory shall meet its obligations at the agreed-to costs.
The Contracted Laboratory may take such actions such as subcontracting if necessary, to ensure project critical obligations are met, such as holding and turnaround times. The Contracted Laboratory shall attempt to notify the applicable Project Manager prior to subcontracting when this will not jeopardize meeting obligations. Notification is waived if the Contracted Laboratory believes the time for notification may jeopardize its obligations; however, an email must be sent to the Project Manager advising of the actions taken.
The Contracted Laboratory shall not seek compensation, and EGLE will not compensate the Contracted Laboratory, more than the agreed-to costs for the project, unless specifically approved by the State Project Manager. When subcontracted services are obtained at lower costs than agreed to with the Project Manager, the Contracted Laboratory shall charge only the actual invoiced costs from the subcontracted laboratory. The Contracted Laboratory may not charge for arranging subcontracting services required to meet agreed-to project obligations.
8.5 The Contracted Laboratory shall take ownership of the deliverables provided from labs providing subcontracted and purchased services, store and maintain such documents as EGLE documents.
9 CHAIN OF CUSTODY (COC) DOCUMENTATION
Along with information routinely provided on the chain of custody, including the identity of the Project Manager, the Contracted Laboratory shall include:
Site/Facility/Incident number.
Site/Facility/Incident name.
State Project Manager overseeing the site for the EGLE.
Site Information - The site number and name information may or may not be identified to the Contracted Laboratory by the Project Manager on the chain of custody when the Project Manager believes these must be hidden to obtain results free of conflict of interests. In such cases the Contracted Laboratory is not required to conduct reviews for discovery of conflict of interests, unless other information exists that identify this information.
10 QUALITY ASSURANCE PROJECT PLANS
The Contracted Laboratory shall review project specifications and plans and submit a laboratory quality assurance project plan (QAPP) to EGLE. The QAPP shall be updated on an annual basis, throughout the lifetime of the contract. All updates shall be submitted to
EGLE.
11 DOCUMENTS AND RECORDS
All originals and copies of information used in the provision of services under contract are referred to as EGLE documents. The Contracted Laboratory shall include as part of their documentation and control the requirements below.
11.1 Laboratory Status and Project Assignments
The Contracted Laboratory shall establish and maintain one file that historically documents the following:
Initial pages (applicable at the time the contract was awarded) Status of laboratory ownership.
Organizational chart.
Copies of certifications and accreditations.
Updates to this file must include the following information, sorted by the date effective or upon sample receipt.
Change in status of laboratory ownership.
Changes in organizational chart.
Changes in certifications and accreditations.
Chain of custodies for EGLE projects.
The Contracted Laboratory shall maintain this file as EGLE documents and provide copies of the file to EGLE when requested.
11.2 Project Specific Files
The Contracted Laboratory shall store documents and records for each project, with appropriate indexes to allow quick retrieval. The Contracted Laboratory shall include in this file any reports and deliverables provided to the Project Managers. Minimally, files should be indexed according to:
Site name, facility name, or incident description, when applicable, Site/facility/incident number, State Project Manager, and date samples were received.
11.3 Document Control
The Contracted Laboratory shall limit access to EGLE documents to its employees as may be required to conduct its business, and to persons with written authorization from EGLE. The Contracted Laboratory shall maintain a log identifying the person accessing EGLE documents and date accessed. The Contracted Laboratory shall provide this log book information to EGLE upon request.
11.4 Retention
The Contracted Laboratory shall retain its documents relevant to EGLE projects in a safe, secure environment for a minimum of seven (7) years upon completion of the project. Retention of documents is the responsibility of the Contracted Laboratory, the costs shall be incorporated into the contract analytical costs.
11.5 Change in Document Status
Prior to the intent to move or dispose, or upon any change in the status of the Contracted Laboratory that may affect the ownership of the documents, the Contracted Laboratory shall notify EGLE, identify the EGLE documents affected, and follow instructions from EGLE to transfer ownership if necessary. The Contracted Laboratory shall, if requested by EGLE, deliver such documents to an EGLE location. The Contracted Laboratory shall allow EGLE to assume ownership at its discretion.
11.6 Sub-Contracted Sample Work Documents (raw and finished data) In order to maintain analytical supporting documentation from any samples that have been sub-contracted out, the Contracted Laboratory shall be responsible for obtaining and maintaining the deliverables from other labs which are not under contract to the State. The Contracted Laboratory shall assure the State that the samples provided to laboratories not under contract to the State are stored, controlled, and retained as required in this document.
12 EFFECTIVENESS AND DOCUMENTATION OF COMMUNICATIONS
12.1 Effectiveness
The Contracted Laboratory shall have mail, telephone, fax and email communication systems that are effective. The Contracted Laboratory is responsible for compatibility of its email with the State’s email system.
12.2 Documentation of Communications
The Contracted Laboratory shall include all communications relevant to the project as part of the project records. The Contracted Laboratory shall verify non-written communications believed to be relevant to the success of the projects through email, printed into portable document format (pdf), and stored with the project information.
13 CONTACTS
13.1 EGLE Contacts
The Contracted Laboratory will encounter the following EGLE RRD contacts:
Project Managers, with the responsibilities to arrange projects, deliver samples, obtain copies of deliverables and reports.
Personnel of EGLE authorized to address invoicing matters.
Contract Administrator authorized to monitor compliance with the requirements of contract.
EGLE lab personnel, who may contact the Contracted Laboratory regarding analyses of samples not completed at the EGLE laboratory, EGLE RRD guidance relevant to the EGLE lab analytical specifications, answer laboratory-specific questions and conduct audits.
13.2 Contracted Laboratory’s Contact for Project Management
The Contracted Laboratory shall identify a primary contact competent to arrange projects with EGLE. The Contracted Laboratory shall identify a backup to the primary contact.
The primary obligation of the primary contact is to coordinate with Project Managers to arrange projects. The primary outcome is a scope of work agreed to between the Contracted Laboratory and the Project Manager. Factors that may be addressed are:
Project objectives as they affect the services provided by the Contracted Laboratory
Sample scheduling Identification and approval of acceptable analyses, target compound lists, reporting limits, and holding times Provision of sample bottles, containers, preservatives and applicable instructions Sample pick-up and delivery Turnaround times Required deliverables Reports of findings Invoicing Costs
13.3 Contracted Laboratory’s Emergency Point of Contact
The Contracted Laboratory shall provide the name of one of its personnel and appropriate contact information for emergency communication, 24/7. An alternate name and information are suggested as a back-up for the Emergency Point of
Contact. This individual must have the authority to recall laboratory staff to perform emergency analytical testing during non-scheduled work hours, including weekends and holidays.
13.4 Contracted Laboratory’s Key Personnel
The Contracted Laboratory shall make its key personnel available to EGLE for matters related to the project, such as project planning, interpretation of results, status reports, and others. Key personnel include:
Laboratory Director Quality Assurance Officer Technical Managers Analysts Primary Laboratory Contact
14 INVOICES
14.1 The Contracted Laboratory shall register as a vendor for the State.
14.2 The Contracted Laboratory shall provide electronic invoices of the content and format required by the Administrative Section of EGLE RRD.
14.3 The Contracted Laboratory shall report electronic invoices in Excel or compatible spreadsheet format, with content as follow Contracted Laboratory identification Identification of EGLE Project Manager Site, facility, or incident number, if available Site, facility or incident name or description, if available Contracted Laboratory’s invoice identification Contract task number and description. Other descriptions without task numbers may be provided when applicable and as appropriate to itemize the cost.
Method identification if cost is for an analysis.
Matrix Number tasks/samples conducted/analyzed.
Cost per task/analysis/item Total cost for task/analysis/item Total invoiced cost for the project
14.4 All invoices shall be signed by an appropriate presentative of the Contracted Laboratory and shall include the following statement, “I certify that the services listed below are proper charges against the State of Michigan.”
14.5 Immediately after providing final reports, the Contracted Laboratory shall distribute the electronic invoices by email to the following parties:
the Project Manager, EGLE Environmental Laboratory Director, and
The State Project Manager.
14.6 Upon request from the EGLE Contract Administrator, the Contracted Laboratory shall report via email to the Contract Administrator a spreadsheet showing the combination of all invoices under this contract, consisting of the combination of the content in 14.4 above, along with a total for all projects.
15 SAMPLE MANAGEMENT
15.1 Sample Delivery
The Contracted Laboratory shall deliver to a location specified by EGLE adequate sampling containers, preservatives, and related consumables, consistent with the applicable regulatory requirements and instructions needed to utilize them.
15.2 Sample Preservative/Bottle Returns
The Contracted Laboratory shall accept returns of their sampling bottles and containers that were not used, and their preservatives regardless of the extent they were used.
15.3 Sample Pick-up
The Contracted Laboratory shall pick up samples at the EGLE Environmental Laboratory located at 3350 N. Martin Luther King Jr. Blvd., Lansing, Michigan, 48906, when requested at no additional cost.
15.4 Mailing and Drop-off of Samples
The Contracted Laboratory shall accept samples mailed through carriers acceptable to the Contracted Laboratory as well as receive samples directly from the State Project Manager or other Project Manager.
15.5 Sample Receipt
Upon a determination that sample receipt criteria are not met, the Contracted Laboratory shall immediately contact and advise the appropriate Project Managers of the deficiency and how it affects the results. The Contracted Laboratory shall follow instructions from the Project Manager regarding whether analyses of the samples are required. If analyses are not required and instructed to dispose of the samples, the Contracted Laboratory shall dispose of the samples at no cost.
15.6 Controlled Access
The Contracted Laboratory shall limit access to EGLE samples to its employees as may be required to conduct is business, EGLE, and to persons with written authorization from EGLE.
15.7 Sample Storage and Disposal
The Contracted Laboratory shall store samples in a safe, secured area with controlled access. Unless otherwise indicated on the chain of custody, the
Contracted Laboratory shall retain the samples for a minimum of thirty (30) days after completion of analysis. When requested, the Contracted Laboratory shall transfer such samples to a location designated by EGLE for no additional costs.
The disposal of samples and any sub-samples created is the responsibility of the laboratory. Once accepted into the laboratory as valid samples, the Contracted Laboratory is responsible for disposal at no cost to EGLE.
15.8 Retention of Sample Extracts and Digestates (Sub-samples) Unless otherwise instructed by the Project Manager, the Contracted Laboratory shall retain sub-samples for thirty (30) days after final reports are provided. The Contracted Laboratory may contact the Project Manager for permission to retain sub-samples for a shorter time.
15.9 Samples Intended for EGLE-Lab
The requirements in the section Sample Pick-Up above apply. Laboratories bidding on this contract must provide a copy of any chain of custodies they use. The Contracted Laboratory shall, when instructed by EGLE:
Pick up samples at the EGLE Lab laboratory location.
Transfer samples into their possession using EGLE Lab protocols and the
Contracted Laboratory’s chain of custody.
Review the chain of custody as provided by the EGLE lab for analyses specifications, including target compounds, holding and turnaround times.
Meet holding times and turnaround times that may be left for the samples using expedited analyses and contact the applicable Project Manager when the specifications cannot be met.
16 ANALYSES
16.1 Acceptable Methods, Target Compounds and Reporting Limits
The Contracted Laboratory shall meet the specifications provided in the EGLE RRD Published List of Target Detection Limits and Designated Analytical Methods or obtain permission from the applicable Project Manager to use revisions of those specifications.
16.2 Review of Requested Analyses for Obvious Errors
Upon assignment of a project and during sample receipt or prior to conducting analyses, the Contracted Laboratory shall conduct a review of the analytical requests in an attempt to uncover obvious non-conformances with applicable guidance. Upon discovery of any, processing of samples shall cease, the Project Manager immediately contacted, and instructions followed.
16.3 Holding Times
The Contracted Laboratory shall meet applicable holding and turnaround times.
Requirements for the regulatory programs administered by EGLE RRD are provided in the Published List of Target Detection Limits and Designated Analytical Methods.
Contacting EGLE - If for unforeseen events holding times are expected to be exceeded, the Contracted Laboratory shall cease processing of the samples and immediately contact the Project Manager. If contact with the appropriate Project Manager are not successful, the Contracted Laboratory shall attempt contact with the following in the hierarchy of the order listed: (1) the State Project Manager, (2) the EGLE district office supervisor for the State Project Manager, (3) the EGLE Field Unit Supervisor, and (4) the Contract Administrator. The Contracted Laboratory shall provide to the person contacted an interpretation of results if analyzed outside of holding times and follow instructions.
Analyses Approved by the Project Manager to be Conducted Outside of Holding Times – If because of actions by the Contracted Laboratory, agreed-to specifications for holding times cannot be met, and the Contracted Laboratory is instructed by EGLE to proceed with the analyses, the Contracted Laboratory shall conduct the analysis at no cost.
Analyses Not Approved by the Project Manager to be Conducted Outside of Holding Times - The Contracted Laboratory shall not seek, and EGLE will not compensate the Contracted Laboratory, for any and all services for samples which results in holding times to be exceeded, and which were not approved by EGLE.
Analysis of Equivalent Samples - If upon notice that holding times will be exceeded, the Project Manager determines the consequences of not meeting holding times renders the data useless, and the cause is solely that of the Contracted Laboratory, the Contracted Laboratory shall cease processing of the samples, not charge for any services conducted for the current samples, and analyze equivalent samples at no charge.
16.4 Method-Specific Quality Control
The Contracted Laboratory shall incorporate sufficient quality control to determine if the method is within appropriate control limits. EGLE may review the Contracted Laboratory’s quality control and make a determination whether the quality control incorporated by the Contracted Laboratory is sufficient. The Contracted Laboratory shall be allowed time to make corrections if it agrees such corrections are necessary.
The criteria and guidance specified in USEPA Test Methods for Evaluating Solid Waste: Physical/Chemical Methods Compendium (SW-846), Chapter One, Project Quality Assurance and Quality Control, is an example of a standard that may be used to make determinations of sufficient quality control.
16.5 Control Limits
When possible, the Contracted Laboratory shall establish and report statistically derived control limits for all compounds that are routinely analyzed and quantitatively reported. See the section below Statistical Control of Method Performance. Compounds reported which do not have statistically controlled limits must be identified along with the rationale for any limits provided.
16.6 Laboratory Control Samples (Spiked Reagent Water)
The Contracted Laboratory shall utilize duplicate laboratory control samples to provide evidence of acceptable accuracy and precision in case the matrix spike information is inadequate to make an evaluation. The Contracted Laboratory shall utilize laboratory control samples spiked with chemicals pertinent to the chemicals of concern for a project when possible. When the Contracted Laboratory believes the laboratory control sample chemicals are not reflective of the chemicals of concern, the Contracted Laboratory shall advise the Project Manager and make recommendations on what actions can be taken.
16.7 Unknown Responses
Unknown responses refer to instrumental responses that the analyst judges to be significant, not due to artifacts of the analyses, and cannot be identified through the calibration process.
Upon discovery of an unknown response for analyses the Contracted Laboratory’s analyst shall:
Inform the appropriate Project Manager as to what can be done to identify the compounds.
If necessary, agree to an estimated cost for identification.
If approved by the Project Managers, make such attempts to identify the compound.
These responses and what was done to identify the compounds must be included in the narratives of the cover letters for the data deliverables. The Contracted Laboratory may charge costs as agreed to with the Project Manager.
16.8 Tentative Identifications of Non-Target Compounds (TICs) When analyses are conducted with TICs, the Contracted Laboratory shall utilize a process and reporting similar to that identified in the EPA Contract Laboratory Program, Multi-Media, Multi-Concentration Organics Analysis (OLM04.3), Exhibit D, Volatiles, Section 11, Data Analysis and Calculations, Qualitative Identification, paragraphs 11.1.2 to 11.1.2.6, or equivalent procedures. Costs for this are included in the analytical costs for Library Search
16.9 Reporting Compounds Routinely Analyzed but Not Requested The Contracted Laboratory shall report all compounds that the method is calibrated for regardless whether requested. All compounds that were detected and not requested must be included in the cover letter narrative.
17 TURNAROUND TIME (TAT)
The Contracted Laboratory shall meet the turnaround times (TATs) specified in project-specific agreements. Subcontracting is an option to meet this obligation. See Subcontracted and Purchased Services above.
17.1 Turnaround Time Specifications
For this contract a TAT is a specific day and time that the Project Manager is expected to receive final results. A TAT otherwise expressed is not appropriate. The Contracted Laboratory shall make such inquiries that ensure the specific day and time results must be received by Project Managers are documented prior to processing the samples. The Contracted Laboratory shall not unilaterally assume a TAT. A specific TAT must be documented.
The Contracted Laboratory shall provide to EGLE a maximum period of time, in calendar days which the lab is in operation, that results can routinely be reported upon receipt.
When a routine TAT is specified by the Project Manager or assumed because of lack of information provided at the time of sample receipt, the Contracted Laboratory shall establish the day which the results will be reported based on that maximum period and so inform the Project Manager by email.
17.2 Data Usability and Turnaround Times
If for unforeseen reasons a TAT is not expected to be met, the Contracted Laboratory shall cease processing, report immediately to the Project Manager and follow instructions. If the Project Manager decides that the data is not usable because the agreed to TAT cannot be met, and the cause is solely due to actions of the Contracted Laboratory, the Contracted Laboratory shall not seek compensation, and EGLE shall not compensate the Contracted Laboratory, for any and all services provided for the samples and analyses. Additionally, the Contracted Laboratory shall conduct analysis of equivalent samples at no cost, if other samples are required to obtain usable data.
18 REPORTS
The Contracted Laboratory shall provide reports showing its findings, with content required by EGLE. The Contracted Laboratory shall have the ability and willingness to adapt to new electronic data deliverables (EDDs) upon the request of EGLE. The Contracted Laboratory shall minimally include the below into its final reports.
INFORMATION
Project cover letter.
Copies of the Chain of Custody Solids results for soils, if applicable and not in final results.
Findings List of all qualifiers and their interpretations.
Electronic results (EDD)
19 PROFICIENCY TESTING
Participation in proficiency testing is a prerequisite for accepting this contract. Contracted Laboratories must provide annual proficiency testing reports to the EGLE Laboratory QA Officer directly from the proficiency testing provider. Contracted Laboratories must provide corrective action reports to the EGLE Laboratory QA Officer for any proficiency tests that are reported as not acceptable.
19.1 Participation for Certification/Accreditation Purposes
The Contracted Laboratory shall participate in proficiency testing provided by an accredited proficiency sample provider and the results from those studies required for the purpose of certifications and accreditations must be provided to document maintenance of the certification and accreditation factors by which the contract was awarded. The Contracted Laboratory shall authorize providers of such proficiency testing to report directly to the EGLE Laboratory Director and results from any subsequent corrective actions that may have been taken.
Unacceptable performance after corrective action will require the Contracted Laboratory to immediately identify additional corrective action and successfully pass a new proficiency sample study.
During this time period, EGLE will use this information to redirect sample submission to other contract laboratories that have successfully passed their proficiency testing.
If upon review of the proficiency testing by EGLE, the matrices analyzed, methods used, and parameters analyzed are not sufficient to verify acceptable proficiency, EGLE will notify the Contracted Laboratory and allow time for correction.
19.2 Minimum Level of Participation
EGLE requires proficiency studies for waters and soils, to be conducted annually, using the labs current revision and implementation of the following methods:
volatiles by 8260, semivolatiles by 8270, including PNAs, chlorinated pesticides by 8081, PCBs by 8082, and metals by the ICPES and ICPMS utilized by the Contracted Laboratory
20 STATISTICAL CONTROL OF METHOD PERFORMANCE
Statistical control refers to the use of statistically derived warning and acceptance control limits for compounds and controls that measure method performance, using results generated in the laboratory. The Contracted Laboratory shall establish statistically derived control limits when possible using data generated by the methods utilized in the laboratory and report those with the results. Regulatory control limits should also be reported when applicable. The applicable Project Manager must be advised prior to acceptance of samples when the laboratory’s statistical control limits exceed any regulatory limits. Statistical control limits must be made available upon request.
21 AUDITS
The Contracted Laboratory shall allow EGLE to conduct document and/or on-site audits to verify adherence to the contract requirements, and when there is cause by EGLE to verify perceived problems. Unannounced audits will initially be limited in scope, covering very specific problems that EGLE believes are affecting the project but may be broadened as determined by EGLE if initial findings warrant further investigation. Announced audits will be arranged with the Contracted Laboratory, identifying the scope, schedule and audit team.
EGLE shall report any perceived deficiencies uncovered during audits to the Contracted Laboratory and allow a reasonable time for correction. Unacceptable Corrective Action will result in reassignment of existing samples to another contract laboratory. Assignment of departmental samples will be taken into consideration if identified deficiencies are significant and adversely impact the data quality of the samples.
22 NEGOTIATION OF DISPUTES
Issues Project Managers have regarding the Contracted Laboratory’s services will be handled as follows:
22.1 EGLE Contractors
Project Managers employed by EGLE Contractors should first make inquiries to the Contracted Laboratory regarding perceived issues. The EGLE lab should first be contacted to assist in identifying issues. The Contract Administrator should be contacted to assist in identifying issues related to the contract. If these initial inquires do not resolve issues, then the State Project Manager should be advised that there are unresolved issues and payments should be withheld pending further review. The State Project Managers should then so advise the RRD Administration Section handling the invoicing that payment is pending. If upon further review and efforts with the Contracted Laboratory are unsuccessful to resolve issues, the Project Manager should assemble documents making its case to withhold payment and provides such documents to the State Project Manager and the Contract Administrator.
22.2 State Project Manager
The State Project Manager may optionally contact the Contracted Laboratory in an attempt to resolve issues, with assistance from the Contract Administrator and the EGLE lab. If issues remain unresolved, the Contract Administrator will assemble relevant documents, meet with the State Project Manager and EGLE lab to clarify the EGLE position, and schedule a negotiation meeting with Contracted Laboratory, Contract Administrator, EGLE Laboratory, Project Manager and DTMB.
Issues remaining unresolved must be handled as provided in this contract, Contract Claims and Disputes.
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