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Document Title: Comprehensive Quality Assurance Manual Eurofins Document Reference: Not Applicable Revision: May, 2017 Effective Date: 5/01/17 COMPANY CONFIDENTIAL Eurofins Document Reference Not Applicable Revision May, 2017 Effective Date 5/01/17 Status Effective Historical/Local Document Number Comprehensive Quality Assurance Manual Local Document Level ESA-MA Prepared by Kimberly LaPlante Reviewed and Approved by (name/date) Reviewed and Approved by (name/date) 11 ALMGREN DRIVE,AGAWAM, MA x SAMPLE DEPARTMENT x HEALTH AND SAFETY x WET CHEMISTRY/MICROBIOLOGY DEPARTMENT x SEMI-VOLATILE DEPARTMENT x INORGANIC DEPARTMENT 830 SILVER STREET,AGAWAM, MA x VOLATILE ORGANIC DEPARTMENT x AIR DEPARTMENT x ADMINISTRATIVE OFFICES x QUALITY ASSURANCE DEPARTMENT Uncontrolled BIOLOGY LOGY TMENT MENT MENT MENT R STREET TREET A A TILE ORGAN E ORGAN DEPARTME EPARTME DMINISTRA NISTRA QUALITY UALITY Copy , MA MA EPA Christina White, 4/28/17 Nicole Leja, 5/01/17

Transcript of Uncontrolled Copy - Eurofins

Document Title: Comprehensive Quality Assurance Manual

Eurofins Document Reference: Not Applicable

Revision: May, 2017 Effective Date: 5/01/17

COMPANY CONFIDENTIAL

Eurofins Document Reference Not Applicable Revision May, 2017

Effective Date 5/01/17 Status Effective

Historical/Local Document Number Comprehensive Quality Assurance Manual

Local Document Level ESA-MA

Prepared by Kimberly LaPlante

Reviewed and Approved by (name/date)

Reviewed and Approved by (name/date)

11 ALMGREN DRIVE, AGAWAM, MA

SAMPLE DEPARTMENT

HEALTH AND SAFETY

WET CHEMISTRY/ MICROBIOLOGY DEPARTMENT

SEMI-VOLATILE DEPARTMENT

INORGANIC DEPARTMENT

830 SILVER STREET, AGAWAM, MA

VOLATILE ORGANIC DEPARTMENT AIR DEPARTMENT ADMINISTRATIVE OFFICES QUALITY ASSURANCE DEPARTMENT

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TILE ORGANE ORGANDEPARTMEEPARTME

DMINISTRANISTRAQUALITY UALITY

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, MAMA

EPA

Christina White, 4/28/17

Nicole Leja, 5/01/17

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REVIEW AND APPROVAL

This Comprehensive Quality Assurance Manual is designed for use by Eurofins Spectrum Analytical’s in-house guidance and will be furnished to the client upon request. It is not intended for use or distribution to the public.

Modifications and revisions of this manual will be subject to review by the Quality Assurance Manager, Team Managers and final review and approval by the President and Laboratory Director. The dated signature of the President will be the effective date of this version of the Quality Assurance Manual.

Nicole Leja President

Christina White Laboratory Director

Kimberly LaPlante Quality Assurance Manager

Digitally signed by Kimberly LaPlante DN: cn=Kimberly LaPlante, o=Eurofins Spectrum Analytical, Inc., ou=QA Department, [email protected], c=US Date: 2017.04.27 15:45:13 -04'00'

Christina WhiteDigitally signed by Christina White DN: cn=Christina White, o=Eurofins Spectrum Analytical, ou, [email protected], c=US Date: 2017.04.28 11:12:31 -04'00'

Digitally signed by Nicole Leja DN: cn=Nicole Leja, o=Eurofins Spectrum Analytical, Inc., ou=ESAI, [email protected], c=US Date: 2017.05.01 11:25:31 -04'00'

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TABLE OF CONTENTS Section Page

1.0 POLICY STATEMENT 11.1 Mission Statement…………………………………………………………………1 1.2.1 Internal Employee Support ..................................................................................... 3 1.2.2 Client Support ......................................................................................................... 3 1.2.3 Advertising Policy .................................................................................................. 5 1.3 Complaints .............................................................................................................. 5 1.3.1 Internal .................................................................................................................... 6 1.3.1.1 Operational Related within Department ................................................................. 6 1.3.1.2 Operational Related Outside the Department ......................................................... 6 1.3.1.3 Personnel Issues ...................................................................................................... 61.3.2 External Complaints................................................................................................ 6 1.3.2.1 Service..................................................................................................................... 6 1.3.2.2 Quality of Data........................................................................................................ 7 1.4 Corporate and Individual Ethics ............................................................................. 7 1.5 Confidentiality/Security.......................................................................................... 9 2.0 Organization and Responsibilities 11 2.1 Organizational Structure ....................................................................................... 11 2.2 Training................................................................................................................. 162.3 Quality Assurance Managerial Organization........................................................ 17 2.4 List of Key Personnel and Positions ..................................................................... 18 2.5 Housekeeping Policies .......................................................................................... 18 3.0 Quality Assurance Objectives 19 3.1 Data Quality Objectives........................................................................................ 19 3.2 Quality Assurance Communication Procedure..................................................... 20 3.3 Quality Assurance/Quality Control Review ......................................................... 20 3.4 Quality Control Acceptance/Rejection Criteria .................................................... 21 3.5 Stoppage of Non-Conforming Work .................................................................... 21 3.6 Preventative Action............................................................................................... 21 4.0 Specialized Analytical Methods 24 4.1 Microbiology Analysis.......................................................................................... 24 4.1.1 Standard Operating Procedures............................................................................. 24 4.1.2 Record Maintenance ............................................................................................. 24 4.1.3 Temperature Records ............................................................................................. 24 4.1.3.1 Autoclave .............................................................................................................. 24 4.1.3.2 Incubators............................................................................................................. 25 4.1.4 Laboratory Reagents and Chemicals .................................................................... 25 4.1.5 Laboratory Water .................................................................................................. 25 4.1.6 Laboratory Glassware ........................................................................................... 25 4.1.7 Maintenance of Laboratory Instrumentation and Equipment. .............................. 25 4.1.8 Instrument Calibration Requirements. .................................................................. 25 4.1.9 Sample Collection, Preservation and Handling. ................................................... 25

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4.1.10 Analytical Methodology. ...................................................................................... 25 4.1.11 Sterility of Rinse/Dilution Water and Sample Bottles.......................................... 26 4.1.12 Residue Testing of Glassware............................................................................... 26 4.1.12.1 Inhibitory Residue Test..................................................................................... 26 4.1.12.2 Bromthymol Blue Test...................................................................................... 26 4.1.13 Microbiological Media – Quality Control Measures ............................................ 26 4.1.14 Miscellaneous Quality Control Measures............................................................. 27 4.1.15 Membrane Filter Procedure Quality Control Specifics ........................................ 27 4.2 Air Analysis .......................................................................................................... 27 4.2.1 Standard Operating Procedures............................................................................. 28 4.2.2 Record Maintenance ............................................................................................. 28 4.2.3 Laboratory Standards ............................................................................................ 28 4.2.4 Sample Containers ................................................................................................ 28 4.3 New Jersey Extractable Petroleum Hydrocarbon Method (NJ EPH) ................... 29 4.3.1 Standard Operating Procedures............................................................................. 30 4.3.2 Record Maintenance ............................................................................................. 30 4.3.3 Laboratory Reagents and Chemicals .................................................................... 30 4.3.4 Quality Control ..................................................................................................... 304.3.5 Laboratory Glassware ........................................................................................... 30 4.3.6 Maintenance of Laboratory Instrumentation and Equipment ………………… 30 4.3.7 Instrument Calibration Requirements. .................................................................. 30 4.3.8 Sample Collection, Preservation and Handling. ................................................... 30 4.3.9 Analytical Methodology. ...................................................................................... 31 5.0 Sample Handling 32 5.1 Sample Containers ................................................................................................ 32 5.2 Sample Acceptance Policy.................................................................................... 32 5.3 Sample Receipt Protocols ..................................................................................... 33 5.4 Sample Tracking ................................................................................................... 36 5.5 Storage Conditions................................................................................................ 36 5.6 Sample Disposal.................................................................................................... 37 6.0 Calibration Procedures and Frequency 39 6.1 Equipment Calibration Information...................................................................... 39 6.2 Instrument Calibration Information ...................................................................... 39 6.3 Standard Traceability, Preparation and Handling................................................. 39 7.0 Standard Operating Procedures and Test Methods 41 7.1 Standard Operating Procedure Development and Modification........................... 41 7.2 Documentation of SOPs........................................................................................ 42 7.3 Test Methods......................................................................................................... 43 8.0 Internal Quality Control Checks 44 8.1 Laboratory Quality Control Samples .................................................................... 44 8.2 Method Detection Limits/Reporting Limits/LOD Verification/LOQ................... 44 8.3 Sample Dilution Policy ......................................................................................... 46 8.4 Selectivity ............................................................................................................. 46 8.5 Method Validation ................................................................................................ 46

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8.6 Control Charts....................................................................................................... 47 8.7 Estimation of Uncertainty ..................................................................................... 47 9.0 Data Reduction, Validation, Reporting and Records 49 9.1 Data Reduction and Validation............................................................................. 49 9.2 Report Format and Contents ................................................................................. 51 9.3 Records and Document Control............................................................................ 53 9.4 Transfer of Records............................................................................................... 54 10.0 Performance and System Audits 55 10.1 External Performance Audits................................................................................ 55 10.2 External System Audits......................................................................................... 55 10.3 Internal Performance Audits ................................................................................. 56 10.4 Internal System Audits.......................................................................................... 57 10.5 Management Review ............................................................................................ 57 11.0 Facilities, Equipment, Reagents, and Preventative Maintenance 59 11.1 Laboratory Facilities ............................................................................................. 59 11.1.1 11 Almgren Drive – Agawam, MA ...................................................................... 59 11.1.2 830 Silver Street – Agawam, MA......................................................................... 60 11.1.2.1 Volatile Organic (VOC) Department................................................................ 60 11.1.2.2 Air Laboratory .................................................................................................. 60 11.2 Laboratory Reagent Storage ................................................................................. 60 11.3 Equipment and Reference Materials..................................................................... 60 11.4 Documentation and Labeling of Standards and Reagents .................................... 61 11.5 Computers and Electronic Data Requirements ..................................................... 61 11.6 Preventive Maintenance........................................................................................ 62 11.7 Inspection/Acceptance Requirements for Supplies and Consumables ................. 63 12.0 Routine Procedures Used to Evaluate Data Quality 64 12.1 Method Blanks ...................................................................................................... 64 12.3 Surrogate Recoveries ............................................................................................ 64 12.4 Matrix Spikes and Matrix Spike Duplicates (MS/MSD)...................................... 65 12.5 Duplicates ............................................................................................................. 65 13.0 Corrective Actions 66 13.1 Isolated Conditions ............................................................................................... 66 13.2 Systematic Conditions .......................................................................................... 66 13.3 Instrument Checks ................................................................................................ 67 13.4 Departure from Documented Procedures.............................................................. 69 14.0 Review of Requests, Tenders and Contracts 70 14.1 Distribution of project plan among Management Team. ...................................... 70 14.2 Results of Review. ................................................................................................ 71 14.3 Record Maintenance ............................................................................................. 71 15.0 Subcontracting and Support Services and Supplies 72 15.1 Subcontracting Laboratory Services ..................................................................... 72 15.2 Outside Support Services and Supplies ................................................................ 72 Revisions………………………………………………………………………………. 74

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ATTACHMENTS

Appendix A Eurofins Spectrum Analytical State Certifications Massachusetts Laboratory

Appendix B Section 1 Attachments Ethical Conduct and Data Integrity Agreement Typical Ethical and Data Integrity Issues

Appendix C Section 2 Attachments Figure 2.1 Organizational StructureResume of Nicole Leja; President Resume of Christina White: Laboratory Director Initial Demonstration of Capability Form Instrument Demonstration of Capability Form

Appendix D Section 5 Attachments Sample of Chain of Custody Sample of Air Chain of Custody Sample Integrity Form Sample Label and Custody Seal Examples

Appendix E Section 6 Attachments Table 6.1 Calibration for GC/MS Laboratory Table 6.1A BFB Key Ions and Abundance Criteria for Methods 624, 8260 Tuning and Direct Injection Table 6.1B FTPP Key Ions & Ion Abundance Criteria Table 6.2 Calibration Procedures GC Laboratory Table 6.3 Calibration Procedures for Inorganic Laboratory Table 6.4 Calibration Procedures Organic Characterization Lab

Appendix F Section 7 Attachments Standard Operating Procedures Master List SOP Request for Creation or Modification Form

Appendix G Section 11 Attachments Table 11.1 Reagent Storage Table 11.2 Analytical Support Equipment

Appendix H Section 12 Attachments Table 12.1 Concentration Levels for QC Samples Table 12.2 QC Frequency Information: Method Blanks

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Table 12.3 QC Frequency Information: Blank Spikes (BS) also known as Laboratory Control Samples (LCS) and Standard Reference Materials (SRM) Table 12.4 QC Frequency Information: Matrix Spikes (MS) and Matrix Spike/Duplicates (MSD) Table 12.5 QC Frequency Information: Duplicates

Appendix I Section 13 Attachments Table 13.1 QC Sample Acceptance Criteria & Corrective Action: Method Blanks Table 13.2 QC Sample Acceptance Criteria and Corrective Action: Blank Spikes (BS) also known as Laboratory Control Samples (LCS) and Standard Reference Materials (SRM) Table 13.3 QC Sample Acceptance Criteria and Corrective Action: Matrix Spikes Table 13.4 QC Sample Acceptance Criteria & Corrective Action: Duplicates

Appendix J List of Acronyms

Appendix K Definitions

Appendix L Method References

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1.0 POLICY STATEMENT

Introduction

Eurofins Spectrum Analytical, Inc. (ESA-MA) is an environmental testing laboratory in the Greater Springfield area in Agawam, Massachusetts and staffs over 80 employees. Since its inception in 1990, Eurofins Spectrum Analytical’s objective is to provide quality analytical testing services to consulting firms, industries, municipalities and the private sector in a timely manner. ESA-MA specializes in the performance of organic, inorganic, wet chemistry and microbiology analyses in various matrices including air.

A separate building within the same industrial park, located at 830 Silver Street, Agawam, MA, houses our volatile organics and air laboratories as well as our administrative offices. The laboratory facilities have more than 22,000 square feet of office and laboratory space combined. The designs and layouts of the laboratories were chosen to provide efficient sample processing, alleviate possible cross contamination issues and to provide a safe work environment.

Eurofins Spectrum Analytical has provided quality service and technical support to consultants, industries and the public sector since 1990. First certified in its home state of Massachusetts, in 1993 we expanded our certification throughout New England, New York, New Jersey, Pennsylvania and Florida. Additionally, our quality data is accepted in the states of Michigan, Delaware, Georgia, Maryland, and Virginia. ESA-MA is in compliance with all applicable TNI Standards. New York State is the primary accrediting authority, with secondary accreditation through New Hampshire, New Jersey, Pennsylvania and Florida. ESA-MA has also been granted certification by the American Association for Laboratory Accreditation (A2LA) to perform work under the Department of Defense Quality Systems Manual for Environmental Laboratories. A full listing of our currently accredited test methods is available on our website at www.EurofinsUS.com/Spectrum

ESA-MA exhibits a strong business philosophy that consists of professionalism, communication and leadership. This is continually demonstrated through our commitment to provide its clients with both technical expertise and business experience and has created a unique style, which has enabled this laboratory to achieve a higher level of performance. ESA-MA is committed to meet current environmental strategy and comply with EPA and other state agency regulations. ESA-MA bases its internal quality systems on the NELAC standards.

1.1 Mission Statement

Eurofins Spectrum Analytical is dedicated to servicing the needs of our customers in a consistently dependable manner with high quality, cost effective, and safety based environmental analytical laboratory services. As part of the Eurofins network, we have the stability and structure of an established corporation to support overhead functions while retaining the personal aspects and services of the laboratory that was established in

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the early 1990s. Our team remains committed to our clients, our quality, and each other as we focus on future growth and opportunities.

1.2 Quality Policy Statement

We strive to provide the highest quality data achievable by:

Reading and understanding all of the quality documents applicable to each position and implementing the process in our work.

Following all recordkeeping requirements; describing clearly and accurately all activities performed; recording “real time” as the task is carried out; understanding that it is never acceptable to “back date” entries and should additional information be required at a later date, the actual date and by whom the notation is made must be documented.

Ensuring data integrity through the completeness, consistency, and accuracy of the data generated. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). This applies to manual paper documentation and electronic records.

Providing accountability and traceability for each sample analyzed through proper sample handling, labeling, preparation, instrument calibration/qualification/ validation, analysis, and reporting; establishing an audit trail (the who, what, when, and why) that identifies date, time, analyst, instrument used, instrument conditions, quality control samples (where appropriate and/or required by the method), and associated standard material.

Emphasizing a total quality management process which provides accuracy, and strict compliance with agency regulations and client requirements, giving the highest degree of confidence; understanding that meeting the requirements of the next employee in the work flow process is just as important as meeting the needs of the external client.

Providing thorough documentation and explanation to qualify reported data that may not meet all requirements and specifications, but is still of use to the client; understanding this occurs only after discussion with the client on the data limitations and acceptability of this approach.

Responding immediately to indications of questionable data, out-of-specification occurrences, equipment malfunctions, and other types of laboratory problems, with investigation and applicable corrective action; documenting these activities completely, including the reasons for the decisions made.

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Providing a work environment that ensures accessibility to all levels of management and encourages questions and expression of concerns on quality issues to management.

We each take personal responsibility to provide this quality product while meeting the company’s high standards of integrity and ethics, understanding that improprieties, such as failure to conduct the required test, manipulation of test procedures or data, or inaccurate documentation will not be tolerated. Intentional misrepresentation of the activities performed is considered fraud and is grounds for termination.

1.2.1 Internal Employee Support

Eurofins Spectrum Analytical’s commitment extends not only externally to its clients and community, but also internally to support its employees. This commitment focuses on communication and has resulted in the formation of policies of performance and resources for its employees. These policies also enforce the implementation of the quality assurance plan and will correct deficiencies that may develop without jeopardizing the quality of services. This commitment ensures that employees of ESA-MA may perform their job functions without pressures that may adversely affect the quality of their work.

1.2.2 Client Support

ESA-MA is committed to providing its clients with prompt, reliable results at competitive prices. The commitment to support our clients can be demonstrated through the services provided; many at no additional charge. These services include:

a. Rush Service – Eurofins Spectrum Analytical’s standard turn around time for routine analytical parameters is 7-10 business days from sample receipt at the laboratory. Rush service is always available and may be coordinated through the use of our Rush Analysis Request Form. Please ensure that a rush analysis request be sent in advance of sample submittal. This communication will help us prepare for your samples and assure you of the turn around time. Requests may be submitted online via our eServices web page. The availability of rush service is a function of the workload within the laboratory at any given time. Therefore requests for rush services are to be approved by the laboratory prior to sampling. Emergency response services will be handled on a case-by-case basis. Please note that rush service may be subject to a reasonable surcharge. Contact our Quality Services Department for details.

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b. Special Pricing – through the use of Eurofins Spectrum Analytical’s Request for Price Quotation Form (available on our eServices web page). This form allows for further price reductions for particular projects that have more cost-effective requirements.

c. Electronic data deliverable (EDD) - All laboratory reports are posted online and will be securely accessible 24/7 through our eServices web page in pdf format and other EDD formats as requested. These files are automatically generated by our LIMS, and can be used to import into your own software and data management applications. There are several EDD formats available.

d. Sample Containers - Pre-cleaned, pre-preserved sample containers are supplied at no cost provided they return for laboratory analyses. Please allow a minimum of 48 business hours notice to prepare and process your request. Requisitions may be completed online through our web site. Eurofins Spectrum Analytical will ship sample containers to your office at no additional charge provided sufficient notice is given for sample kit preparation and ground shipping or delivery. Additional notice is required for certified low-level air media.

Reliability of any sample data is measured in terms of precision in executing methodologies and accuracy of surrogate and method spike recoveries. Data generated by Eurofins Spectrum Analytical must pass all method-specific and regulatory criteria established under NELAP, the Environmental Protection Agency (EPA) and by each state in which certifications are held. In situations where no criterion has been established, ESA-MA may choose to develop in-house data quality objectives to ensure that reliable data is reported.

Prior to accepting new bid proposals, the Director and the QA Department review the scope of work provided by the client to ensure all specifications can be met by Eurofins Spectrum Analytical. The client is informed at this time if a sub-contract laboratory will be needed to meet scope of work criteria.

The primary QA/QC objective is to develop, implement, improve and maintain procedures for sample receipt, sample preparation, laboratory analysis, data validation and reporting that provides scientifically valid, legally defensible data. Eurofins Spectrum Analytical supports this objective through QA/QC procedures within the laboratory, including all ancillary departments.

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1.2.3 Advertising Policy

It is the intention of Eurofins Spectrum Analytical to accurately represent its accreditations and certifications and in a manner that does not imply accreditation in areas that are outside the actual scope of current accreditation. The laboratory’s accreditation certificate and scope of accreditation issued by NELAP, A2LA or other Federal or State agencies will be posted on the laboratory website. It is not anticipated that additional advertising with respect to A2LA accreditation status of the laboratory will be required. If management determines that additional advertising is necessary, the laboratory will follow the current A2LA Advertising Policy with respect to the activities under the scope of accreditation and use of the A2LA symbol.

Use of the NELAC Accredited logo is allowable with adherence to the following:

a. Where the NELAC logo is used it shall always be accompanied by Eurofins Spectrum Analytical’s accreditation number.

b. The NELAC logo may be generated electronically provided that the prescribed formats and forms are retained.

c. When promoting or providing proof of accreditation, accredited laboratories should use the scope(s) of accreditation, as this document details the specific tests which are accredited. The certificate should be used for display purposes and should also accompany the scope.

d. When the NELAC logo is used on a business solicitation document such as a proposal or quotation form, the laboratory has the responsibility to distinguish between those proposed tests that fall within the laboratory’s scope of accreditation and those that do not. This is done by attaching a copy of the current Scope of Accreditation sheet and/or a link to Eurofins Spectrum Analytical’s Quality webpage were this information is posted or by noting which tests or calibration is non-accredited.

e. Upon suspension or termination of accreditation, the laboratory will immediately inform affected clients and remove or update certification on the Eurofins Spectrum Analytical website.

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1.3.1 Internal

1.3.1.1 Operational Related within Department

Department Managers are available to express department-related disputes, ideas and/or concerns. If an issue deserves research, Laboratory Director attention, or is not resolved immediately, the employee(s) must express the concern in writing in memorandum form to the department manager. (See Standard Operating Procedure for Resolution of Complaints for further information, available upon request)

1.3.1.2 Operational Related Outside the Department

The Laboratory Director and/or QA Manager are available to express laboratory-related disputes, ideas and/or concerns. If an issue deserves research, Laboratory Director attention, or is not resolved immediately, the employee(s) must express concern in writing in memorandum form to the Laboratory Director. The Laboratory Director will respond within 48 hours of written notification.

1.3.1.3 Personnel Issues

The Department Manager is available to express non-operational related disputes, ideas and/or concerns. If an issue deserves research, Laboratory Director attention, or is not resolved immediately, the employee(s) must express concern in writing in memorandum form to the Department Manager or corporate HR. (See Standard Operating Procedure for Resolution of Complaints for further information, available upon request.) All parties will follow company policy set forth in the Eurofins Employee Handbook.

1.3.2 External Complaints

Eurofins Spectrum Analytical puts client support as one of its highest priorities. If a client expresses a complaint or concern it is acted upon immediately. (See Standard Operating Procedure for Resolution of Complaints for further information, available upon request.)

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When a client call is received concerning the services provided by Eurofins Spectrum Analytical it is the responsibility of the person receiving the call to notify the Laboratory President immediately.

1.3.2.2 Quality of Data

When a client calls concerning data results the call is forwarded to the Laboratory Director, QA Manager or authorized personnel (refer to SOP). The matter is looked into upon receipt and if the complaint investigation reveals a laboratory error due to non-compliance with internal procedures, the client is notified within three business days or sooner from discovering the error.

1.4 Corporate and Individual Ethics

Eurofins Spectrum Analytical depends upon the quality of the data and services produced and the integrity of the people who generate them. We recognize the need for and have responded with an ethics program that is designed to establish a meaningful context within the environmental laboratory. Our objective is to provide an effective ethics program that involves training, managerial leadership and active dialogue between our staff. All new employees are trained within the first two weeks of employment and signed documentation is attached to the new employee training form, filed with their onsite personnel folder. Eurofins Spectrum Analytical also provides employees with the ability to anonymously report instances of unethical or improper laboratory practices. The QA Manager or their designee will investigate any suspected instances of ethics violations or improper procedures. Continued employee and managerial training will occur once a year in conjunction with the mandatory Annual Company Meeting, for which all attendance is recorded. Periodic monitoring of data integrity is conducted through departmental management validation against the raw data uploaded by the analyst. Additional validation procedures to ensure data integrity are located in Section 9 of this Quality Assurance Manual. Any employee who displays unethical behavior or intentionally jeopardizes data integrity will be subject to discipline up to and including termination.

We, at Eurofins Spectrum Analytical believe that we share common goals and values. These goals and values include protection of the environment, quality of product and personal integrity.

We strive to be honest when we interact with each other and our clients.

We work to achieve high standards in our procedures and with our final product.

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We will continue to create an environment for personal and professional growth that provides employees with an opportunity to grow, excel and develop new skills and challenges.

We will continue to enhance our internal procedures that provide a well-defined background that is both educational and supportive to both our employees and our clients.

We encourage through our internal programs and by example, responsible procedures that address laboratory wastes and health and safety for all our employees and for our environment. Our laboratory waste program has become a training tool to involve our employees in the ethical disposal of chemical and laboratory wastes.

We strive to respect one another for our variety and our similarities.

We strive to respect one another for our origins and our beliefs, our looks and our gender.

Eurofins Spectrum Analytical and its leadership support the maintenance of the facility, the equipment and instrumentation and, by example demonstrate a willingness to invest in new instrumentation.

While it is the goal of Eurofins Spectrum Analytical to lead and teach by example, it is also true that ethics are guidelines within each individual that are supported by company structure. While most individuals strive to attain a high degree of integrity, there are some actions that occur in laboratories that are considered unethical and can result in penalties or punishments to include legal and civil actions. The following are examples of unethical behaviors with their own nicknames that are unique to laboratories.

Peak shaving – The practice of manually integrating a peak from a point within the chromatogram that will decrease the true value of the analytical contaminant. If the manual integration does not begin and end in a valley, the deviation is considered peak shaving.

Dry Labbing – Creating data for an analysis that was not performed.

Time Travel – Changing the time of an extraction, analysis or sampling to make it appear that the analytical procedure performed was done with in the analytical holding time.

Other actions defined as unethical include forging another’s name or initials, signing that data review has been performed when it was not, spiking a “little extra” to improve recoveries or knowingly condoning unethical observed

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behavior of others. See Appendix B for typical ethical and data integrity issues.

1.5 Confidentiality/Security

The protection of confidential business information and trade secrets is vital to the interest and success of this organization and its clientele. Confidentiality is an absolute condition of employment with Eurofins Spectrum Analytical. At all times and occasions, it is imperative that all employees maintain confidentiality of all information concerning business practices.

Security includes the use of telephones, computers, facsimiles, and any other electronic media systems. Passwords are assigned to each user and the use of all systems can be monitored. Each employee must agree to the terms set forth and sign an acknowledgement form.

Vendors, clients, site locations, and analytical results even though some such information may become a matter of public record, are considered confidential. Listed below is the protocol initiated in order to maintain and support this confidentiality.

The Client Services Department in coordination with the QA Department is the only authorized representative at Eurofins Spectrum Analytical who may release analytical data after final approval by the Laboratory Director.

Anyone requesting a copy of an analytical report or invoice who is not listed on the original Chain of Custody must:

(1) Submit a written request with specific details for the reason for the request;

(2) Obtain written approval from the individual and/or company who are the client of record on the original Chain of Custody.

Eurofins Spectrum Analytical is protected by a security system, which is only accessible by employees who are issued a current security code. No one other than authorized employees can gain access to this system.

All employees receive Computer Security Training upon hiring and participate in a refresher course annually. Training included the use and protection of individual passwords, the requirement to change LIMS passwords annually and the safe use of individual and group computers.

The storage of analytical data and accompanying invoices are accessible only to the Accounting, Client Services, and QA Departments. No one other than authorized employees can access this documentation.

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The Chains of Custody records are accessible by the Sample and Accounting, Client Services, and QA Departments. Only authorized employees can access this documentation.

Any request for quotation and/or client correspondence is considered confidential documentation and will only be accessible to the Client Services Department and authorized personnel. No other operational department will have access to this documentation.

If a request for quotation is submitted by more than one company for the identical public bid, without any question of deviations, Eurofins Spectrum Analytical has an obligation to provide an equal low discounted price for this project.

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2.0 Organization and Responsibilities

Eurofins Spectrum Analytical employs a team of professionals that possess a high-level of training along with at least five years or more technical experience in their related field. Our staff utilizes their scientific and technical expertise to service the analytical and informational needs of our clients and allows us the ability to customize and develop certain scientific procedures that are not part of the existing EPA standard methodologies. These staff diversities enable ESA-MA to produce high-quality data while maintaining our efficiency, quality assurance and effective deliverables and profitability. ESA-MA encourages its staff to revise and develop procedures that will improve the overall function. Present staff qualifications and work experience are on file and can be furnished to a client upon request.

2.1 Organizational Structure

The organizational structure and responsibilities are outlined below and illustrated in Figure 2.1 located in Appendix C for the Massachusetts Laboratories.

President (resume attached in Appendix C) Responsible for assisting with preparation of budget and meeting those goals for each calendar year. Responsible for profits and losses associated with business performance and ensuring operations meet internal and external expectations. Provide technical support and onsite supervision of the operational departments located at 830 Silver St;

Laboratory Director (resume attached in Appendix C) Final review and approval of Microbiology data; The Laboratory Director is responsible for overall supervision of laboratory operations, overseeing all technical and administrative policies and procedures, as well as the enforcement and adherence to said policies by laboratory staff Use tools and processes for performance measurement and benchmarking (KPIs);Assist management and staff with development of cost calculation models (using activity-based costing methodology) such as APPC and capacity modeling;

Is responsible for final data validation and approval of laboratory reports for data generated by both the 11 Almgren Dr and 830 Silver St facilities;

Provide technical support and onsite supervision of the operational departments located at 11 Almgren Drive;

Supervise the revision of and final approval of protocols and methodologies; Ensuring proper data deliverable and client services; Using information collected from all departments and client feedback, the

laboratory director must conduct a review of the laboratory’s quality system and testing activities to ensure their continuing suitability and

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effectiveness, and to introduce necessary changes or improvements. Prepare an annual Management Review with these findings and ensure they are assigned and carried out in an agreed upon timeframe. The President will provide back-up in the absence of the Laboratory Director. If the Lab Director is absent for more than 35 calendar days, the primary AB must be notified.

Senior Operations DirectorShares responsibility with Laboratory Directors for business unit performance in terms of quality, efficiency, and key performance indicators (KPIs) including working within budget and meeting sample TAT expectations; Support overall division and business management to include daily operations, staff scheduling, administrative duties, and policy enforcement; Support the Lean project manager and Lean initiatives; Maintain and repair instrumentation (excluding ICP, ICPMS, and Microwave technologies) and provide internal training to primary analysts; Review current procedures and operational activities and recommend efficiency improvements; Provide oversight and assistance to operational departments on technical issues and aid in professional development; assist LDs with staff training and development and recommend training plans; Stay abreast on current analytical method, technology changes and new techniques and make recommendations for process improvements and upgrades as needed including applicable state programs such as MA DEP CAM and CT DEEP RCP; Recommend, initiate, and support method development to increase instrument sample capacity, maintain or reduce labor costs, and maintain all QC requirements; Assist with data review and validation during high sample volume periods; Support both MA and RI locations for technical improvements and instrument repairs; Must be proactive in prevention and detection of improper, unethical or illegal actions. The Operational Support Manager will be back-up in the absence of the Senior Operations Director.

Quality Assurance Manager Fulfill the role of laboratory Quality Assurance Officer; Implement, maintain and improve upon the overall laboratory quality assurance; Ensure all lab personnel understand their contribution to the quality assurance plan; Conduct initial and annual Ethics and Data Integrity Training; Conduct initial Computer Security Training for new hires: Ensure communication takes place at all levels of the laboratory regarding

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the quality assurance plan; Evaluate the effectiveness of training; Data validation; Conduct annual internal laboratory audits to assure compliance with all aspects of the quality assurance plan; Maintaining the QA/QC database and QA/QC files; Ongoing review and update of QC procedures, QC databases, and protocols; Oversee all aspects of Proficiency Testing including orders, dispersal to the laboratory, ensure operational managers rotate PT analysts, upload results to providers, DMR QA reporting, monitor PT history and corrective actions; Document Control; Maintains Certifications; Oversee and delegate tasks to Quality Assurance Department staff; All responsibilities are conducted in communication with the Laboratory Director and President. The QA Assistant will provide back-up in the absence of the QA Manager.

Operational Support Manager Be available to all laboratory departments for assistance with staff management and training, communications with Client Service and Quality Control, inventory control and maintenance of departmental protocols and procedures.Assist with data processing, review and validation of Organic data as needed;Assist with method updates and maintenance of all instrumentation to include organic (GCs, GCMSs, ECDs) and inorganic instrumentation via communication with Laboratory Director and Senior Operations Director.Assist with Organic (Air, VOC and SVOC) peer review of standards; compilation of LOD/LOQ and MDL studies; other department administrative duties as operationally needed. Responsible for tracking and keeping certifications current for critical laboratory equipment such as weights, thermometers, balances, flow meter, and other devices necessary to operations including sending to vendors for renewal before expiration. Maintenance of the master inventory list updated as new capital items are purchased and older items are taken out of commission. Tracking instrument serial numbers on existing and new equipment and maintaining equipment certifications, as needed. Assist with maintenance of department protocols and procedures and method development. Maintain friendly, working relationships with instrument vendors, salespersons and service personnel keeping the BU up-to-date.

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Help departments utilize tools and processes for performance measurement and benchmarking (KPIs) to include TAT, productivity, scheduling of staff, and optimization of staff and resources. Standardize operational performance reporting with a clear focus on laboratories production with recommendations for process improvements. On a daily basis communicate with the BUMA, Laboratory Director, Operations Director, and Operational Department Managers. As needed, keep Quality Service Department and the Quality Assurance Department aware of any issues that may affect service or quality of our products. The Operational Support Manager must have a sufficient background to competently support all laboratory processes.The Senior Operations Director will be back-up in the absence of the Operational Support Manager.

Lean Project Manager Responsible for on time completion of milestones Distribute and review tasks, owners and deadlinesResponsible for the long term Continuous Improvement Present results to BU and corporate Lean Coordinator Complete analysis and document outcomes

Continue to gain knowledge of lean tools

Quality Services Department Overall client service management; Preparation of bids and price quotations; Development of flyers, ads, etc. Data reporting; Invoice preparation; Scheduling of courier service via client contact; Publish laboratory data reports; Communicate with clients regarding data deliverable; Maintain laboratory report files; Manager to support Operational Department in manager’s absence; Manager will have a link to Marketing Department. The Client Services Manager will provide back-up in the absence of the Quality Services Deputy Director.

Accounting Department Track all incoming vendor invoices and outgoing client invoices; Track all payables;

Courier Service Department Coordinates daily pick up schedule;

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Oversees sample container inventory; Oversees preparation of sample kits for client deliveries; Communicates with Laboratory Director regarding courier service schedule and all incoming samples; Oversees all shipping from facility. The Quality Services Deputy Director will provide back-up in the absence of the Courier Manager.

Operational Departments Manager - Oversees overall data management; Manager - Provides technical support; Manager - Coordinates operational issues to Laboratory Director; Manager - Provides validation support to QA Department as secondary validator.Manager – Supervision of personnel including hiring and training; Performing sample preparation and analysis in accordance with all applicable methodology and internal SOPs; Processing data generated by laboratory instrumentation; Performing daily QA/QC checks on each instrument; Maintaining communication with QA Department regarding quality issues and data deliverable; Adherence to Health and Safety and Chemical Hygiene Plans; Maintain and implement all the department functions stated above with specific responsibilities listed for each position; Review all logbooks within prescribed frequency; Review and implement QA/QC samples and standards as stated in the methods performed on a daily basis; Review the daily backlog for due date, holding time, etc. and assign work order to each analyst; Ensure PT samples are rotated among all trained analysts; Conduct a brief daily meeting with assistants in order to meet daily objectives. The Laboratory Director or Operational Support Manager will provide back-up in the absence of the Operational Department Manager.

Air Department Method development; Marketing air division; Provide technical support such as air presentations; Perform various air analyses; such as TO15 and APH along with customized analyses as requested.

Sample Department Verifies the integrity of all samples received and inspects incoming Chains

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of Custody for completeness; Ensure all inter-company communication regarding incoming expedited TAT samples; Ensure data entry accuracy from Chain of Custody into Laboratory Information Management System (LIMS) database; Communicate with clients regarding any COC deviations as defined under NELAC protocol and our Comprehensive Quality Assurance Manual; Identify incoming samples with their unique identification provided by the LIMS database; Preparation of samples for subcontracting laboratory when applicable. The Quality Services Deputy Director will provide back-up in the absence of the Sample Department Manager.

Health and Safety Department Implementation of Eurofins Spectrum Analytical’s Chemical Hygiene Plan and enforcement of laboratory safety rules; Coordination of safety related staff training; Sample/waste disposal and storage. The Lean Project Manager will provide back-up in the absence of the H&S Manager.

Information Systems Department Maintenance of all internal network functions; Program development; Assists with marketing strategies. Eurofins NSC will provide back-up in the absence of onsite IT.

2.2 Training

Eurofins Spectrum Analytical’s training program applies to all employees. All job functions are fully described in a formal job description, which is kept on file in the lab. To be hired or promoted, an employee must meet all job description requirements. All hiring and subsequent changes in personnel are documented in the individual’s permanent personnel file. Various training programs are provided for new employees or employees transferred to a new position. Additionally, certain positions require auxiliary training, including training videotapes, on-site training classes, or off-site attendance of specialized training or certification courses. Each analyst hired must perform an Initial Demonstration of Capability (see Appendix C) before processing and reporting data. This study is used to demonstrate the precision and accuracy of the individual analyst.

All hiring, training and position changes follow the policies and procedures set forth in the Eurofins Employee Handbook. Training is arranged and planned by

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the operational department, reviewed by the Quality Assurance Department and approved by the Laboratory Director. Before commencing employment with Eurofins Spectrum Analytical, all potential staff members are informed of their ethical and legal responsibilities. This includes client confidentiality, health and safety procedures, and communication within the laboratory. The employee must review and sign the Eurofins Employee Handbook before starting as an employee. This handbook details all company policies and penalties for not complying with the procedures and policies. Along with the Handbook, each employee is required to review the laboratory’s Comprehensive Quality Assurance Manual, specifically the sections that are pertinent to their job responsibilities. Once this section has been reviewed, the employee will sign the training form stating that he/she has read and understands the information provided. Upon completion of a revised QA Manual, all personnel are assigned the updated revision in the online SOP program. They must read and electronically sign off on the updated QA Manual, acknowledging they have read and understand the most recent revision.

2.3 Quality Assurance Managerial Organization

The managerial team under the direct supervision of the Laboratory President and QA Manager will enforce the implementation of the Comprehensive Quality Assurance Manual. Listed below are routine quality organization functions:

a. Daily communication occurs between the Laboratory Director and Managers. The Laboratory Director is kept up to date regularly throughout the day for any immediate executive decisions. The Operational Support Manager (communicates data deliverable information and any technical or instrument issues for the Organic Sections). All departments have daily Flash Meetings to discuss current and future workload, KPIs and operational issues.

b. Weekly Performance Meetings are held with senior management to discuss lab status. A weekly status update is emailed to the Laboratory Director by each department manager detailing any performance issues.

c. Monthly Performance Review - this meeting is held on a monthly basis (or as needed) and is under the direct supervision of the Laboratory Director. Managers for all departments attend this meeting.

d. Quarterly BU Performance Review: this meeting is under the direct supervision of the Laboratory Director and each operational manager in order to evaluate the operational plans developed by each department and their efficiency at meeting goals during the year.

Employee Performance Evaluation - all employees are evaluated on a yearly basis by the department managers and the Laboratory Director.

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2.4 List of Key Personnel and Positions

Employee Name Position Held Nicole Leja President

Christina White Laboratory Director Dulce Litchfield Deputy Director of Quality Services Kimberly LaPlante Quality Assurance Manager Patrick Sullivan Senior Operations Director Kevin White Lean Project Manager Wes Bryon Operational Support Manager Rebecca Merz Quality Services Manager Emily Kinney Air & Volatile Organic Manager

Sandra Mateega Semi-Volatile Organic Manager Jackie Clement Metals Manager

Raquel Thomas Wet Chemistry Manager John Miller Health & Safety Manager Joel Navaroli Information Technology Kathryn Wilkinson Sample Receiving Manager

2.5 Housekeeping Policies

The laboratory follows stringent housekeeping procedures both utilizing internal policies performed by employees and contracting with an external cleaning group.

Internally, all employees are responsible for the cleanliness of their own area. This includes reagents, cleaning and placement of glassware, etc. The Laboratory Director routinely oversees all procedures.

The Health and Safety Manager performs an internal audit of the entire laboratory on a monthly basis and reports his findings to the Laboratory Director with suggested comments.

In addition, a cleaning company has been contracted who performs a thorough cleaning for both facilities three times per week or on an “as needed” basis following the necessary precautions as to not interfere with the efficiency of the laboratory.

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3.0 Quality Assurance Objectives

Eurofins Spectrum Analytical follows the well-defined EPA standards for validation and data accuracy as the foundation of our QA/QC effort. The primary QA/QC objective is to develop, implement and maintain procedures for sample receiving, sample preparation, laboratory analysis, data validation and reporting that provide scientifically valid, legally defensible data. ESA-MA supports this objective through QA/QC procedures throughout the laboratory, including all ancillary departments.

Clients are encouraged to submit a blind duplicate sample at no additional charge, which will be tested as part of the routine samples. Testing the blind sample enables ESA-MA to check the accuracy and consistency of our procedures and gives our clients the utmost possible degree of confidence in the data.

ESA-MA is so confident in its accuracy that when applying for certification renewals, the required proficiency tests are run on a rush basis. This is done because 70% of our projects require an expedited turnaround time; therefore if we can run and pass the all-important proficiency tests using our rush procedures, we have further proven the accuracy of our ongoing technique.

Our use of reliable and technically sound instrumentation, the experience of our chemists, and our well-trained support staff are additional components to our QA/QC program.

3.1 Data Quality Objectives

Data quality objectives (DQOs) are quantitative and qualitative statements specifying the quality of the environmental data required to support the decision-making process. DQOs define the total uncertainty in the data that is acceptable for each specific activity during sample analysis. This uncertainty includes both sampling error and analytical error.

The parameters that are used to specify data quality requirements and to evaluate the analytical system performance are precision, accuracy, representativeness, completeness, and comparability (PARCC). Definitions for these parameters are presented below:

Precision: a measure of the reproducibility of measurements under a given set of conditions.

Accuracy: a measure of the bias that exists in a measurement system.

Representativeness: the degree to which sample data accurately and precisely represent selected characteristics.

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Completeness: a measure of the amount of the valid data obtained from the measurement system compared to the amount that is required.

Comparability: a measure of confidence with which one data set can be compared with another.

3.2 Quality Assurance Communication Procedure

ESA-MA has instituted a Quality Assurance Communication Procedure (QACP) in order to strengthen the quality organization within the laboratory. The effectiveness of this procedure enables a timely response to problem situations and the creation of innovate concepts, enhancing the quality of both the analyses and the services provided by ESA-MA.

The following outlines specific quality assurance communication activities.

Managerial communication is conducted between the Laboratory Director and the team leaders: (Operational Departments, Quality Assurance, Quality Service, Sample, Courier, Technical Service Departments, and Air Division) to handle the overall daily laboratory functions (see Section 2.0 – Organization Structure and Responsibilities).

Data deliverable communication deadlines: all operational departments report to the Laboratory Director regarding the status of their data deliverable no later than 11:30 AM via the daily rush program.

Data validation communication updates: the validation team is in constant communication with the Operational Departments regarding data quality issues that may require immediate action. The Laboratory Director will immediately be notified.

Departmental communication update: the department manager must meet with his/her assistant and/or coordinator on a daily basis to discuss various actions such as: daily workload, quality control issues, instrumentation issues, personnel and others.

3.3 Quality Assurance/Quality Control Review

It is necessary to continually review and evaluate all laboratory procedures to ensure compliance with state and federal regulations. This includes procedures for data validation, daily laboratory operation, and corrective actions. The Laboratory Director, along with the QA Department and Directors, meet frequently to discuss if procedures need to be changed in order to meet compliance. If any procedure is changed a written memorandum is sent to all

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pertinent laboratory personnel. These memorandums are issued a control document number, stored on the network and backed up regularly.

The Laboratory President, Director and QA Department meet at the end of each calendar year to discuss the quality systems in place. The Department Managers are evaluated on the quality systems within the laboratory during the end of the year performance review. If necessary, managers meet with the Director and QA Manager more frequently to address quality issues.

3.4 Quality Control Acceptance/Rejection Criteria

Acceptance and rejection criteria are based on methodology and instrumentation. Eurofins Spectrum Analytical will use method guidelines for criteria levels. Quality control samples are charted periodically to determine upper and lower acceptance levels for in-house method acceptance and rejection criteria. The Laboratory Director is responsible for final decisions regarding data acceptability.

3.5 Stoppage of Non-Conforming Work

When quality control data falls outside of the laboratory’s acceptance criteria, the Laboratory Director, QA Manager, Validation Team and department managers have the authority to halt the analysis of samples. QA Department staff has the authority to halt work if any compliance issues are found with a laboratory method or process. Before any work can resume, laboratory personnel must identify the non-conformity. Once the issue has been identified, the client must be contacted to inform them of the non-conformity and how their data may be affected. After a thorough investigation, the data may be narrated or, if deemed appropriate, a corrective action may be enacted. Once satisfied that the non-conformity has been sufficiently addressed, the Laboratory Director, QA Manager, Validation Team or department managers may authorize work to resume.

3.6 Preventative Action

All employees are empowered and encouraged to use the concept of Preventive Action to avoid a problematic situation. The company supports, embraces and drives the process for continuous quality improvement by several means, such as: Ethics Hotline, open door policy for suggestions and training classes that include Ethics and "Essential Technical Training for Laboratory Personnel". If an employee identifies a potential problem or an area of concern or it should be brought to the attention of his/her supervisor, Human Resources, QA Director or the Ethics Hotline.

The laboratory also utilizes a formal program to encourage preventive action through development of lean processes. The goal of this program is to optimize

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processes to ensure efficiency and operational improvements while maintaining compliance. The efficiency gains are inherently coupled with minimizing errors and rework. Teams of employees learn the tools and techniques to evaluate a process, identify potential sources of errors, delays or problems in an operation, determine system changes that will minimize these and work to implement the improvements. Each project includes thorough documentation of the evaluation, measurement, and implementation phases. The process is continually monitored to ensure that the anticipated results are sustained.

Employees are also encouraged to communicate to their supervisor any area(s) or operation(s) that they believe could be streamlined, make their job easier, would provide a quality improvement, or could provide a cost savings to the company.

Described below are some of the systems available to employees to assist with building quality and efficiency into their daily jobs. They stress a proactive approach/environment to problem solving and to review quality systems and operational efficiencies.

Ethics Training is a seminar required for all employees to teach the laboratory’s Statement of Values by examining how it translates to our everyday jobs and ethical decision making. Topics discussed include: Statement of Values, ethical paradigms, and ethical decision making. Mandatory ethics training refresher seminars are offered on an annual basis.

The laboratory has contracted with an Ethics Hotline to provide an anonymous means of reporting ethics concerns or issues. The issue is forwarded by the service to the QA Director who will communicate internally with those who need to address the issue. All communication and actions are documented in a secure web interface managed by the hotline service company.

The QA staff prepares monthly program status reports for management. The reports include a variety of metrics which are used to evaluate trends in laboratory performance across all quality and compliance areas. Management responds to any negative trends by developing a corrective action plan.

QA staff undergoes intensive training including how to perform internal audits, review internal investigations for thorough root cause analysis and corrective action and Eurofins seminars "Follow the Yellow Brick Road to Quality Management" and "Top 10 Suggestions For Being A Better QAO". Eurofins encourages collaboration between all US QAOs to share experience and best practices to improve laboratory quality and efficiency.

Operational Departments continuously monitor control charts to look for trends and out-of-control situations. When an adverse trend or out-of-control

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condition is indicated on a control chart, the nature of the condition is used to determine the type and extent of corrective action (if required). Corrective actions can include, but are not limited to, instrument maintenance, replacing a degrading standard or recalibrating an instrument that is showing repeated problem.

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4.0 Specialized Analytical Methods

4.1 Microbiology Analysis

There are several critical elements for analysis of microbiological samples. The department supervisor must have completed at minimum one college-level course in which environmental microbiology was covered. Academic transcripts and resumes are available upon request for the supervisor and analysts.

The operational room for microbiological analyses has sufficient storage and bench-top space and is equipped with fluorescent lighting. It is separated from other operational work areas and authorized personnel only are permitted in the laboratory area.

4.1.1 Standard Operating Procedures

Necessary equipment is available to perform the analyses. This includes pH meter, balance, an incubator unit, hot air oven, colony counter, conductivity meter, and an autoclave for disposal of microbiological samples. Support equipment is also available, such as culture dishes, pipettes, culture tubes and closures, inoculating equipment, membrane filtration equipment, sample containers and glassware, and an ultraviolet lamp. Specific care and maintenance of this equipment is detailed in the Standard Operating Procedures (SOPs) for methods performed.

4.1.2 Record Maintenance

Record maintenance follows the normal procedures of Eurofins Spectrum Analytical Refer to Sections 9.3 and 11.5 of this manual.

4.1.3 Temperature Records

Daily records of the incubator are maintained for each day of use. The temperature for the incubator is recorded from a thermometer immersed in liquid and placed on a shelf. The temperature is recorded twice a day with a minimum of four hours between each reading.

Refrigerators used to store samples, media and reagents are maintained at a temperature range of 1 C to 5 .

4.1.3.1 Autoclave

The date, time, temperature and duration for each sterilization cycle are recorded. A list of materials

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sterilized is maintained and initialed by the analyst who has performed the work.

4.1.3.2 Incubators

The temperature of each incubator is recorded twice daily with a minimum of four hours between each reading. The temperature is documented in the appropriate logbook.

4.1.4 Laboratory Reagents and Chemicals

Analytical reagent grade chemicals are used for all analyses performed. Procedures for receipt at the laboratory, labeling reagent bottles and preparation of standards is detailed in Section 11 and the corresponding SOP.

4.1.5 Laboratory Water

Distilled water is prepared in the operational laboratory room and meets the requirements for Type II water as defined by the ASTM. Water quality is verified daily for conductivity and monthly and annually for suitability according to method requirements. This is also referenced in the method SOP. Reagent-grade water quality is monitored in accordance with Standard Method 9020 B Inter-laboratory Quality Control Guidelines.

4.1.6 Laboratory Glassware

Sterile sample containers are commercially prepared. Glassware used within the operational laboratory is cleaned according to method requirements. Specific details can be found in the SOP.

4.1.7 Maintenance of Laboratory Instrumentation and Equipment - Please refer to Section 11.3 and method specific SOPs.

4.1.8 Instrument Calibration Requirements - Please refer to Section 6.0 and method specific SOPs.

4.1.9 Sample Collection, Preservation and Handling - Please refer to Section 5.0 and method specific SOPs.

4.1.10 Analytical Methodology – Methods performed are accepted and approved by the EPA for the matrices and analytes of interest. These methods are referenced in laboratory SOPs.

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4.1.11 Sterility of Rinse/Dilution Water and Sample Bottles

Preparation of sterile rinse water is detailed in the SOP. Sterilization is checked using Tryptic Soy Broth. Each lot of sample containers received for microbiology analyses is checked for sterility by selecting one container. Containers are not used until satisfactory results are obtained from the tested bottle.

4.1.12 Residue Testing of Glassware

4.1.12.1 Inhibitory Residue Test

The cleaning process of glassware using a detergent or similar product is checked to ensure it is free from toxic material after rinsing based on the use of the Inhibitory Residue Test as specified by Standard Method section 9020 B (3), Inter-laboratory Quality Control Guidelines, Laboratory Supplies.

4.1.12.2 Bromthymol Blue Test

Each batch of clean glassware is tested for residual alkaline or acid residue using bromthymol blue indicator. If the results of the indicator test are not acceptable corrective action is immediately taken. Refer to Section 13.0 and/or method SOP for corrective actions.

4.1.13 Microbiological Media – Quality Control Measures

Media is used in the order that it is received. The date, type, amounts, and date opened is recorded for each media received by the laboratory. Media is kept no longer than one year after opening and is stored in a dessicator.

The media dispensing apparatus is checked for accuracy before each sample batch analysis using a graduated cylinder. Accuracy is checked again with each change in volume or periodically throughout extended runs.

Documentation is kept for sterilization of all media, including analyst, lot number, date, sterilization time and temperature and the final pH.

Water sources with known contaminants shall be used on each new lot of medium to determine performance with previously acceptable medium.

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4.1.14 Miscellaneous Quality Control Measures

A minimum of one bottle per lot of sterilized sample containers supplied with sodium thiosulfate is checked for residual chlorine using standards at 5 mg/l and 15 mg/l. The sodium thiosulfate tablet must be able to remove both low and high levels of chlorine residual. If testing shows that sodium thiosulfate inadequately removes the chlorine, the vendor will be contacted and the lot will be rejected.

Heat sensitive tape is used along with a thermometer to verify stabilization temperatures in the autoclave.

Water baths are used to temper media. Please refer to SOP for cleaning procedures.

The optic and stage of the microscope is cleaned before each use.

4.1.15 Membrane Filter Procedure Quality Control Specifics

Documentation is kept to record lot numbers and date of receipt for all membrane filters.

A sterility media check for each filter unit is performed at the beginning and end of each sample analysis batch. If the control indicates contamination all data for affected samples is rejected and an immediate re-sample is requested.

Verification of Membrane Filter Colonies – see method SOPs. E-Coli bacteria are used for positive control and S. Epidermis is used for negative control.

Each analyst must prove method proficiency by analyzing quality control samples yearly for known and unknown performance samples. Duplicate analyses are performed once per month per analyst on positive samples.

4.2 Air Analysis

Air analysis may be performed for various parameters using different methods and instrumentation. The parameters that may be tested include volatile organic compounds, air phase petroleum hydrocarbons, sulfur, fixed gases and metals. The Air Department is run under the supervision of a well-experienced chemist.

Sources of samples can vary from residential or commercial locations, factories, ambient air, stacks, soil vapor points, vapor extraction systems, landfills, and other location where contamination is suspected.

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The volatile air laboratory instruments are comprised of two Agilent 5973 and two Agilent 5975 mass spectrometers interfaced with an Entech 7100 pre-concentrator and a 7016 autosampler. There is an inventory of over 200 passivated sampling canisters and 100 passivated flow regulators. Canisters are cleaned by an Entech 3100 sixteen position cleaner that heats the cans to 100 degrees C during the process.

Metals are analyzed using a ICP and a modified microwave digestion procedure.

The two prominent gases used extensively are helium, used as a carrier gas, and. liquid and vapor nitrogen, used frequently for instrument cool down, flushing systems and as a diluent gas. All gases are located in the storage garage of laboratory and plumbed into laboratory sections. The air laboratory also has a dedicated air handling system for AC and in laboratory air filtration.

4.2.1 Standard Operating Procedures

All analytical procedures have documented Standard Operating Procedures (SOPs). The SOPs are written and updated as modifications to the methods are accepted and performed.

4.2.2 Record Maintenance

Record maintenance follows the procedures outlined in Sections 9.3 and 11.5 of this manual.

4.2.3 Laboratory Standards

Laboratory standards are purchased as certified standards at 1 PPMv. They are then diluted to lower concentration using the Dynamic Diluter. The most common dilution is the internal standard to 50 PPBv, the calibration gas to 50 PPBv and 10 PPBv and the quality control gas to 10 PPBv.Other standards for special analytical work such as formaldehyde or haloethane are made from neat standards using the static dilution (expansion flask) technique. It is then introduced into the sampling container using the dynamic diluter.

4.2.4 Sample Containers

Sample may be collected in either passivated stainless steel canisters or tedlar bags. Two size canisters are used; 3.2 liters and 6.0 liters. Both canister and tedlar bags can be attached to the auto sampler for analysis. Tedlar bags supplied by the laboratory are one-liter bags with a non-metal fitting. Other size bags with different fittings may also be analyzed.

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Passivated stainless steel containers are coated with a polymer coating that allows for the most inert surface possible (Normal summa canisters are just stainless steel). The passivated process is either called Silcosteel or Silonite. All canisters have vacuum gages attached to their valves for monitoring the vacuum before, during and after sampling takes place.

Flow regulators, which attach to the canisters, can be set for sampling from 0.5 hour through to a 1-week timeframe. These have also undergone the passivating process.

All canisters are cleaned after analysis and before reuse. The can cleaner has sixteen positions and has the ability to heat the cans to 100 degrees C. The cans are attached to the cleaner, pressurized with N2 and heated. After about one hour the can cleaner will evacuate and pressurize the cans three times using a roughing pump. After the third cycle, a molecular drag pump is activated which will vacuum the can to < 50 militorr. It runs with the molecular drag pump overnight. After completion, the canister which had the most contamination detected during analysis is pressurized with N2 and analyzed. All analytes must be below the detection limit for a batch to be considered properly cleaned. If any analytes are above detection limit then the whole batch is re-cleaned.

All flow controllers are cleaned by flowing N2 through them at 2-5 psi for 10 Minutes.

4.3 New Jersey Extractable Petroleum Hydrocarbon Method (NJ EPH)

The NJ EPH analysis is conducted in the Semi-Volatile Department. Soil samples are extracted by sonication utilizing method SW846 3545A and water samples are extracted by Separatory Funnel Extraction utilizing method SW846 3510C. Both soil and water samples are extracted using methylene chloride as the solvent and 1-chlorooctadecane and ortho-terphenyl as extraction surrogates. All water samples and soil samples known to contain #2 fuel oil (2FO) are then analyzed by GCFID. Soil samples of unknown contamination are solvent exchanged to hexane. Fractionation surrogate, 2-bromonaphthalene and 2-fluorobiphenyl, are added and the sample is fractionated through silica gel into aliphatic and aromatic portions. The aliphatic is analyzed by GCFID. The aromatic is analyzed by GCMS.

It is the clients’ responsibility to inform the lab if there is known 2FO contamination in soil samples. If there is no communication, all soil samples will undergo fractionation.

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4.3.1 Standard Operating Procedures

All analytical procedures have documented Standard Operating Procedures (SOPs). The SOPs are written and updated as modifications to the methods are accepted and performed.

4.3.2 Record Maintenance

Record maintenance follows the procedures outlined in Section 9.0 of this manual.

4.3.3 Laboratory Reagents and Chemicals

Analytical reagent grade chemicals are used for all analyses performed. Procedures for receipt at the laboratory, labeling reagent bottles and preparation of standards are detailed in Section 11 and the corresponding SOP.

4.3.4 Quality Control

Every NJ EPH batch contains (20 samples or less) contains the following lab QC samples:

DFTPP every 12 hours 100ppb Continuing Calibration Check (CCC)Lab Solvent Extract Blank Lab Control Spike (LCS) Lab Control Spike Dup (LCSD) Silica-gel Fractionation Check Matrix Spike (Aqueous if provided enough sample volume) Duplicate (Aqueous if provided enough sample volume)

4.3.5 Laboratory Glassware

Glassware used within the operational laboratory is cleaned according to method requirements. Specific details can be found in the SOP.

4.3.6 Maintenance of Laboratory Instrumentation and Equipment - Please refer to Section 11.3 and method specific SOPs.

4.3.7 Instrument Calibration Requirements - Please refer to Section 6.0 and method specific SOPs.

4.3.8 Sample Collection, Preservation and Handling - Please refer to Section 5.0 and method specific SOPs.

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4.3.9 Analytical Methodology – NJ EPH Method performed is accepted and approved by the NJ Department of Environmental Protection for the matrices and analytes of interest. This method is referenced in laboratory SOP.

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5.0 Sample Handling

The validity of a sample analyzed is, at best, only as good as the techniques used when collecting and handling said samples. Proper sample collection, handling and preservation techniques are imperative in order to impede the biological and chemical transformations that occur once a sample is removed from its parent source. The following summarizes steps taken to maintain sample validity.

5.1 Sample Containers

Pre-cleaned “Class A” sample containers, as required by EPA and the TNI Standards, are provided by the laboratory at no charge to the client via Eurofins Spectrum Analytical’s online system or Sample Container Request Form (see Appendix D). Each shipment has available a certificate of analysis documenting that the glassware is reagent free for target compounds of environmental analyses. The certificates of analysis are scanned, kept on file electronically and backed up by IT. Sample containers are purchased pre-preserved from the vendor or are preserved and tested by lot as needed by the laboratory before being delivered.

5.2 Sample Acceptance Policy

Eurofins Spectrum Analytical is committed to maintaining the integrity of all samples submitted for laboratory analyses. If there is any question or concern regarding the integrity of a sample, the Laboratory Director is notified and immediate action is taken.

All samples submitted must have durable labels attached to each container identifying the sample ID, site location, and/or project number and the collection date written in indelible ink. The ESA-MA employee receiving samples must review the information on the Chain of Custody for completeness and inspect all the sample containers to ensure proper labeling and sample integrity. Any corrections to COC information must be made by using a single horizontal line to strike through the incorrect entry and they must initial and date the correction. The COC is then signed and the date and time of possession are recorded. The duplicate copy of the COC is given to the client as documentation of receipt. Eurofins Spectrum Analytical retains the original COC for the final client report and laboratory files. Please see Appendix D for an example of the Chain of Custody, sample label and Custody Seal.

The acceptance of any sample is based on the following criteria:

Full and complete documentation, including sample collector’s name on the COC The identification of a sample container is not questionable or unidentifiable

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The sample collection date is within the holding time of analysis specified There is sufficient sample The sample is properly preserved and it is in the appropriate container VOA vials do not contain air bubbles of sizes greater than 1% of the vial volume

Please refer to Eurofins Spectrum Analytical’s website under Sampling for the “Table Recommended Containers, Preservation, Storage & Holding Times” for correct sample containers, preservation, and holding times.

The Sample Department will contact clients in regards to any samples considered to be of unsatisfactory condition. Documentation of this notification will be attached to the COC for record keeping purposes.

Analysis of any samples deemed unsatisfactory will be conducted only with client approval and will be documented in the following manner:

The unsatisfactory condition will be noted on the COC and supporting documentation The condition of the samples as received in the laboratory will be noted on the final report.

5.3 Sample Receipt Protocols

The following checks are performed upon laboratory receipt of samples:

(1) Check the temperature of samples:

ESA-MA determines the temperature of samples. A notation of the temperature reading will be recorded on the Chain of Custody record along with a notation of how the samples were received (e.g: on ice, refrigerated, ambient).

(2) Verify the integrity and condition of all sample containers:

Check for leakage, cracked or broken closures or containers, evidence of grossly contaminated container exteriors or shipping cooling interiors, obvious odors, etc. The VOC department does a check for air headspace or bubbles in VOC containers and samples are qualified if detected. Were cooler custody seals present? Were custody seals intact?

Any compromised conditions will be noted on the COC and supporting Sample Integrity Form (See Appendix D).

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(3) Verify COC information for completeness:

Clients name in the Report To section Site name and location Sample identification, collection date, and matrix Type and number of each sample container Sample preservation All requested analyses should be clearly indicated The COC is relinquished by the sampler

(4) Verify receipt of complete documentation on the label for each sample container:

Sample identification Collection date and time Site name and/or client project number Verify that the sample information on the label corresponds to the sample information on the COC

(5) Verification of Sample Preservation

Field preservation of any sample must be clearly documented on the COC. Any preservation should be performed in accordance with the tables within this section. Any sample preservations that are inadequate or not performed by the sampler are corrected prior to assigning samples to laboratory departments with the exceptions noted below.

In order to maintain sample integrity and alleviate possible volatile loss, samples for the determination of Volatile Organic Compounds will be checked for pH and chlorine residual (EPA 524.2) after the samples have been analyzed. The results will be documented in the appropriate logbook and the correct qualifier will be indicated on the final report.

The pH will not be checked on any samples for microbiology testing. All bacteria sample bottles are tested to insure that adequate dechlorinating agents are present. This information is documented along with the sterility of the containers.

The Inorganic Department will conduct any necessary pH adjustments of samples for the determination of Trace Elements by ICP or ICP/MS after sample filtration if necessary.

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Samples submitted for the petroleum hydrocarbon analysis such as method 1664B will be checked by the analyst for pH. In the event that the sample contains noticeable hydrocarbons, the Pasteur pipette will be rinsed with the method solvent to insure that no hydrocarbons have been inadvertently removed.

The Log-In Analyst will conduct all other laboratory preservation of samples.

An aliquot is tested against litmus paper by touching a disposable pipette to litmus paper to verify the sample pH. Litmus paper is never inserted into the sample.

(6) Evidentiary Samples

Samples received with a legal Chain of Custody are logged-in in the same manner as non-evidentiary samples, with the exception that they are stored in a secure location. Access is monitored by designated personnel. Sample movement is tracked by the LIMS. Eurofins Spectrum Analytical’s sample disposal policy is not applicable to evidentiary samples; clients are notified prior to storage time expiration for direction to hold or dispose of remaining samples. Clients must notify the laboratory that a sample must be handled under legal COC procedures prior to receipt. See the SOP for Sample Documentation and Login for specific details.

(7) Sample Confirmation Email

Upon entry into the Laboratory Information Management System (LIMS), the sample receipt conditions are emailed to the client. Below is an example of information included in this notification.

The following outlines the condition of samples for the attached Chain of Custody upon receipt.

Were cooler custody seals present? Answered Yes or No

Were custody seals intact? Answered Yes, No or N/A

Were samples received at a temperature of 6°C? Answered Yes or No

Were samples cooled on ice upon custody transfer to laboratory representative?

Answered Yes or No

Were samples refrigerated upon custody transfer to laboratory representative?

Answered Yes or No

Were sample containers received intact? Answered Yes or No

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Were samples properly labeled (labels affixed to sample containers and include sample ID, site location, and/or project number and the collection date)?

Answered Yes or No

Were samples accompanied by a Chain of Custody document? Answered Yes or No

Does Chain of Custody document include proper, full, and complete documentation, which shall include sample ID, site location, and/or project number, date and time of collection, collector's name, preservation type, sample matrix and any special remarks concerning the sample?

Answered Yes or No

Did sample container labels agree with Chain of Custody document? Answered Yes or No

Were samples received within method-specific holding times? Answered Yes or No

5.4 Sample Tracking

Upon receipt of samples, the information listed on the Chain of Custody is transferred into the Laboratory Information Management System (LIMS). The computer then assigns a unique, sequential laboratory identification number for each Chain of Custody with a unique identifier extension for each sample and container. In order to ensure that there may be no confusion regarding the identity of any sample, it is henceforth identified as this number. A sequential log is maintained for all samples received to assist in tracking purposes.

5.5 Storage Conditions

Samples are stored in the receiving area refrigerator or freezer until sample log in is complete. At this time, the Log-In analyst will properly label each sample container with the unique laboratory ID number and distribute them to the appropriate operational department(s) after verifying sample integrity and preservation. Security within the facility is maintained at all times so that only authorized personnel have access to samples. The facility is equipped with a state of the art alarm system. Important notes about storage are listed below:

Laboratory refrigerator temperature is maintained at a temperature of <6°C and not frozen; freezers are maintained at <-10oC. Refrigerator and freezer temperature is monitored continuously with hourly readings by electronic probe to ensure compliance with this guideline. Two consecutive readings are taken at 6:00 AM and 6:30 AM and again at 7:00 PM and 7:30 PM. If the two consecutive readings are out of compliance, a temperature exceedance alert is generated and corrective action is taken.

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Sample fractions, extracts, eluates, leachates, digestates, etc. are stored in accordance to EPA guidelines as specified in the applicable method utilized to prepare or analyze the sample.

Samples and all sub-samples, sample fractions, extracts, eluates, leachates, and digestates are stored separately from all standards, reagents, and cleaning supplies.

Samples to be analyzed for VOCs are stored in a separate refrigerator specified for VOC samples only.

Storage blanks are placed in all refrigerator and freezer units that hold VOC samples in both the sample login area and VOC lab. The blanks are appropriate to the type of samples being stored (e.g. Deionized Water blank held in the low level VOC freezer) and are stored in each unit for 14 days. At that point, they are removed, logged into the LIMS system and analyzed for VOCs and GRO in a batch with all necessary QC samples. The data is validated by the QA Department and evaluated for any potential laboratory contamination. Detections in a VOC storage blank may result in qualification of that analyte in affected samples, narration, client contact and/or maintenance action to eliminate the source of the contamination. The QA Department will notify the VOC department and Validation Team of detections as necessary to coordinate any corrective actions.

5.6 Sample Disposal

All samples are disposed of after 30 days unless otherwise specified for return to the client. Samples are kept refrigerated for 14 days. They are then removed from the refrigerators, boxed and labeled with the appropriate disposal date, and kept in the sample staging area for the remaining 16 days. Sample fractions, extracts, eluates, leachates, digestates, etc. are refrigerated for 40 days before being disposed of.

The Sample Disposal Technician, under the supervision of the Health & Safety manager, is responsible for all sample disposals. All samples and sub-samples are disposed of in a manner consistent with all applicable federal, state, and local regulations and in accordance with Eurofins Spectrum Analytical’s Chemical Hygiene Plan, available upon request.

International soils are disposed of in accordance with the United States Department of Agriculture (USDA) soil permit requirements, as indicated in the Eurofins Spectrum Analytical’s International Soil Disposal SOP. International soil samples are kept in a locked refrigerator for a minimum of 14 days. They are

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then removed under the supervision of the Health & Safety manager into a lock box located near the refrigerator. After 30 days from receipt, the soil samples are moved to a locked disposal storage cabinet for the Microbiology department to autoclave prior to disposal. When the samples are removed from the locked disposal storage cabinet, the analyst enters the IDs into a logbook identified as the International Soil Sterilization Record. This record includes the sample ID and the date and time of sterilization.

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6.0 Calibration Procedures and Frequency

Laboratory equipment and instrumentation must be calibrated at periodic intervals as outlined by governing agencies, applicable methodology, and/or by the manufacturer’s recommendations. The nature and frequency of such checks are summarized in each applicable SOP. All calibrations are traceable to primary standards of measurement. Where the concept of traceability of measurement to primary standards is not applicable, the laboratory provides evidence of correlation or accuracy of test results. The laboratory maintains appropriate records of all calibrations, instrument tunes, and in-service checks of instruments and other equipment.

Each operational department keeps a maintenance logbook for each instrument to track routine maintenance due to instrument malfunction and/or troubleshooting. The Department Manager and the QA Department review these maintenance logbooks periodically.

6.1 Equipment Calibration Information

Measurement devices, such as balances and thermometers, are verified using standards whose calibrations are traceable to the National Institute of Standards Traceability (NIST). A certificate of the calibration is generated by the certifying agency and maintained on our network. Balance calibrations are verified daily using S-Grade, Ultra Class weights and independently on an annual basis through by an ISO accredited vendor. All refrigerator thermometers are substantiated annually against the laboratory’s NIST certified thermometer. The NIST thermometer and reference weights are verified and certification is renewed on an annual basis by an ISO accredited vendor.

6.2 Instrument Calibration Information

General calibration information for laboratory instrumentation is listed in Tables 6.1-6.4 in Appendix E. For specific information regarding calibration procedures, please refer to laboratory SOPs.

6.3 Standard Traceability, Preparation and Handling

All standards used for calibrations are either ISO certified or certified by the supplier through analysis with EPA certified or NIST traceable weights and measurements.

The commercially prepared stock standards require dilution to the working concentration. Comparing the new working level concentration against the previously prepared lot checks the accuracy of the dilution. The preparation of working standards may be tracked through the LIMS and Standard Preparation Logbook by date of preparation and/or assigned ID. The analyst preparing the

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working standard records the weight/volume, concentration and vendor lot number of stock standards used, the type of solvent used, his or her initials, the date of preparation and the date of expiration. The vendor reference codes may be cross-referenced to a separate inventory logbook that lists all neat or stock standards received by the laboratory, the date of receipt, vendor, and lot number.

New volatile working standards are prepared from these stocks each week. Semi-volatile stock standards are prepared every seven weeks and working level standards are prepared every four to six weeks, depending on the laboratory consumption rate. Pesticide stock standards are prepared yearly; working level standards are prepared every two to four weeks, depending on the laboratory consumption rate. Alachlor standard stocks are also prepared yearly, with working level standards prepared approximately every two to three months, but not to exceed six months.

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7.0 Standard Operating Procedures and Test Methods

Standard Operating Procedures (SOPs) have been created in accordance with EPA approved methods and state developed methods, such as the MA DEP EPH/VPH and NJ TPH methodology. For procedures that do not have specific method references, Eurofins Spectrum Analytical has developed and tested the procedures followed and then created the corresponding SOP. Eurofins Spectrum Analytical reserves the right to designate select SOPs containing technical knowledge of methods and technology as proprietary information. Complete copies of proprietary SOPs are not provided outside of the lab. Copies of the cover page may be provided if clients require evidence an SOP is in place.

Standard Operating Procedures (SOPs) are in place within each department in the laboratory for each method and/or procedure performed. They are designed to outline the procedures to be followed for the applicable method or administrative function. The Master List of all SOPs is maintained and kept within the QA Department. A copy of the SOP Master List, current at the time of this revision of this QA Manual is located in Appendix F. An updated copy is available upon request.

7.1 Standard Operating Procedure Development and Modification

It is the QA department’s responsibility to initiate updates in SOPs due to change in protocols, EPA and state method modifications, state regulatory agency correspondence, method cancellations or new methods. Included in each SOP are references for the method performed. Each operational department reviews SOPs at the beginning of the calendar year for possible revision and on an as needed basis through the rest of the year. Comments on possible modification or revision are due to the QA Manager within one month. SOP revision consists of the following steps:

A. The Laboratory Director, QA Manager or Department Manager will assess the need to update, revise, or create a SOP. In all cases a standardized form must be completed stating the name of the SOP and the modifications that wish to be made or the reason for creating a new SOP. The form must also explain why this is occurring; i.e. method changes, internal procedure changes, or new instrumentation. This form is kept on file within the QA Department. See Appendix F for example of SOP Modification Form.

If the form originates from the Laboratory Director or QA Manager, it is given to the Department Manager. The Manager must then modify or develop the applicable SOP and return it to the QA Manager for review within the designated timeframe.

If the form originates from the Department Manager, it must be given to the QA Manager for evaluation. The QA Manager and Laboratory

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Director will either approve or deny the request. When approved, the Department Manager must complete the modification or development within the designated timeframe and return the SOP to the QA Manager for approval. When denied, the form is kept on file by the QA Department.

B. The Laboratory Director will conduct the final review of the SOP revision for approval and implementation. The SOP must include the date of revision and be signed and dated by the analyst or manager that has created or modified the document, secondary reviewer and the Laboratory Director. The date of implementation is the date the SOP is signed by the Laboratory Director.

Once finalized, a controlled copy is uploaded in the SOP program and assigned to the applicable analyst(s). All assigned personnel must immediately read and sign the updated SOP. The SOP program maintains a record in the Compliance Grid of who read each SOP revision and when. The QA Manager uploads and assigns the controlled copy and immediately inactivates the old revision. Old SOP revisions are archived electronically. The changes made to the SOP are documented in the Revisions section of each SOP.

Updates to Eurofins Spectrum Analytical Comprehensive Quality Assurance Manual are similarly performed. Changes are documented in the Revisions section. Once a new revision is finalized and signed by senior management, all laboratory personnel are notified that the QAM has been updated. The QAM is uploaded into the SOP program. All SAI personnel are instructed to read the sections that apply to them and sign-off in the SOP program attesting that they have read, understand and agree to abide by the requirements detailed in the QAM. This acknowledgment is retained within the SOP program.

7.2 Documentation of SOPs

The QA department maintains the original SOPs electronically in a folder on the network with restricted access. The current revision is uploaded into the lab’s SOP program and all applicable personnel are assigned the SOP to read. An automatic email is sent to the assigned personnel and the department management to alert them that an SOP has been assigned to them to read. An individual may review the SOP and acknowledge that they have read and understood the document through the program. In addition, the program maintains a record of who has or has not read an assigned SOP, if any pages from the SOP have been posted in the lab, the date of the last annual review and will notify the user when the next annual review is due. It is the responsibility of the QA department to update SOPs in the program when a new revision is

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created and replace any posted pages with the updated version. Only the most current revision of each SOP is available to personnel at any time.

When modifications are made, the revision number must be changed to reflect this. SOPs are numbered sequentially.

SOPs must be kept within the laboratory unless the Laboratory Director gives permission for them to be taken off the premises.

SOPs are available to clients upon request and are marked as an ‘Uncontrolled Copy’. The QA department is not responsible for collecting ‘Uncontrolled Copies’ when a revision is made.

All of the SOPs are copied onto a 4.7GB DVD. One copy is kept in fire-resistant safe and another copy is stored off-site. The DVD is updated with each new SOP or modification.

7.3 Test Methods

Experienced analysts perform test methods. The complete procedure, including standard preparation, extraction/digestion, sample preparation, instrumentation used, calculations, and data interpretation/validation is documented in Standard Operating Procedures (SOPs). An electronic copy of the current method is maintained on our network and the SOP Master List references the version currently used for each method. When a method version is changed, the out-dated copy is removed from the network by the QA department and replaced with the updated version. In this way, the departments will only have access to the current method revision.

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8.0 Internal Quality Control Checks

The analytical and quality control requirements for each sample are performed via the Laboratory Information Management System (LIMS). The LIMS is accessible from any workstation. A system of specific analysis codes is used to schedule the appropriate analytical procedures and the QC samples required to be processed with each batch of samples.

8.1 Laboratory Quality Control Samples

Various quality control (QC) procedures are associated with the methods run by the laboratory. These procedures are defined in the laboratory SOP for each method. The type and frequency of QC samples are specified by methods and detailed in each SOP. Such methods include CLP Organic and Inorganic SOW methods, Test Methods for the Evaluation of Solid Waste (SW-846, most current update), Standard Methods for the Examination of Water and Waste, ASTM or methodologies as listed in the Federal Register (40 CFR Part 136 and 141, most current update)

All quality control checks meet the minimum requirements outlined below.

A. The laboratory will follow the minimum quality control requirements specified by each method.

B. In the event that no quality control requirements are listed in the method, or if the method quality control requirements are less stringent than those listed below, the laboratory will follow the minimum guidelines:

1. method reagent blanks 2. matrix spikes 3. quality control check samples 4. quality control check standards 5. duplicates or matrix spike duplicates 6. surrogates

8.2 Method Detection Limits/Reporting Limits/LOD Verification/LOQ

Described here are ESA-MA’s policies for the determination of MDLs, RLs, LOD and LOQ. For specific details, please refer to our SOP for MDL/LOD/LOQ and the analytical SOPs. These documents are available upon request. The Method Detection Limit (MDL) also known as the Limit of Detection (LOD) is defined as “the minimum concentration of a substance that can be measured and reported with 99% confidence that the analyte concentration is greater than zero” and is determined from analysis of a minimum of seven prepared blank spikes. Method detection limits are determined according to procedures given in 40 CFR

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Part 136, Appendix B. http://www.ecfr.gov/cgi-bin/text-idx?SID=2bad19ea8d6db04e2c8f7666ddb00943&node=ap40.23.136_17.b&rgn=div9 MDL studies are performed during method validation studies to establish a base value. Updates to the MDL on all instruments/methods will be performed every twelve months by carrying out a new study or by completion of a Limit of Detection (LOD) Verification analysis. MDL updates are also done when new instruments are put on-line, if the configuration of the instrumentation is significantly changed, or if the sample preparation method is modified.

Limit of Detection (LOD) Verification is defined as an estimate of the minimum amount of a substance that an analytical process can reliably detect. An LOD verification is analyte, matrix, extraction and instrument specific and may be laboratory dependent. ESA-MA uses the concentration of the Detection Check Standard (DCS) for the LOD verification. The LOD verification must be spiked at a concentration no more than 3 times the MDL for single analyte tests, no more than 4 times the MDL for multiple analyte tests and no greater than the RL. LOD verifications are analyzed either quarterly or annually, depending on the accrediting agency’s requirements.

Limit of Quantitation (LOQ) is defined as the minimum levels, concentrations, or quantities of a target variable (e.g., target analyte) that can be reported with a specified degree of confidence or the lowest concentration that produces a quantitative result within specified limits of precision and bias. For DoD projects, the LOQ shall be set at or above the concentration of the lowest initial calibration standard. ESA-MA defines the LOQ = RL. A minimum of four consecutive replicates are analyzed at a concentration of the lowest initial calibration standard; however, LOQ may be analyzed as high as 2 times the reporting limit. LOQs are analyzed either quarterly or annually, depending on the accrediting agency’s requirements.

In general, the lowest value ESA-MA may use, (for non-DOD) as a reporting limit is the method detection limit. However, because the MDL as defined above is known to allow the reporting of false negatives, ESA-MA generally uses a value that is greater than the MDL. For organic and general chemistry tests, a standard at the reporting limit is generally included in the initial calibration. For metals tests, the reporting limit is a set value greater than the MDL (ideally three to five times the MDL). If samples are analyzed for compliance with regulatory programs that have requirements for reporting limits that are greater than normal reporting limits, the reporting limit may be adjusted up to the regulatory limit. The MDL based on the above discussion, are dynamic values, which are expected to vary as a result of the periodic detection limit studies. The reporting limit is a static value (as a general rule) with the flexibility to be adjusted to meet project requirements provided that it is not lower than the most recently determined MDL. Although standard policies may be set for determination of normal report

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limits, the specific report limit for each target must be reconsidered for every sample by viewing the applicable analytical data.

Detection and reporting limits are adjusted to reflect dilutions, reductions in the initial aliquot of sample prepared (due to limited volume/mass of original sample or reduction in volume/mass prepared based on knowledge of the sample) or in the case of soil samples, moisture content (unless directed otherwise by the client, e.g., DoD). Dilutions are required to analyze samples within instrument or calibration constraints, and the presence of moisture in soil samples always results in increased limits.

8.3 Sample Dilution Policy

When possible, based on in-house screening results and physical characteristics of the sample/sample extract, samples are analyzed without dilution to achieve the lowest reporting limits feasible for the method requested. Data from in-house screening is not performed with all method required QA/QC and therefore is not reported. If screen data and/or physical characteristics note significant concentrations of target compounds may be present the original analytical run is performed at a dilution.

Additional runs are performed if over or under dilutions are initially performed on a client sample. The analytical run with the lowest reporting limit is included in the final report and multiple runs may be reported if target compounds exceed the instrument calibration range in the original run.

Samples containing target compounds that exceed the instrument calibration range generally cannot be analyzed with a lower dilution factor, however depending on the sample matrix, target compound and final concentration, and method requested additional runs can sometimes be attempted. Please contact your laboratory representative on the feasibility of this deviation for a specific project or sample location.

8.4 Selectivity

All data is thoroughly checked by the analyst and the manager for each department. Unusual or inconsistent results are confirmed either by running a duplicate or by other procedures specific to each method. These procedures are listed in the method SOPs. Also contained in the method SOPs are the acceptance criteria for calibration and mass spectral tuning.

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Before using any method, an initial demonstration of capability must be completed successfully. This includes MDL/LOD studies, IDC studies, and any other procedures specific to each method.

8.6 Control Charts

Control charts are a useful tool when monitoring the quality system within the lab. Spike recoveries are plotted on quality control charts on a continuous basis as a means of ascertaining whether an out-of-control condition is a result of systematic or random (statistical) error. Eurofins Spectrum Analytical has a Control Chart program that automatically searches the LIMs for trending analytes. It emails the department when any analyte is trending ± 5% of the acceptance range. A minimum of 30 data points are used to generate the charts and also show standard deviation, the mean, 2S and 3S lower and upper limits for review. Data points will only be excluded when there is a scientifically valid reason to do so. Department managers, or their designee, will review the control chart for trending and out-of-control situations. When an out-of-control condition is indicated on a control chart, the nature of the condition is used to determine the type and extent of corrective action (if required). An explanation for each out-of-control data point will be documented into the control chart program. Corrective actions can include, but are not limited to, instrument maintenance, replacing a degrading standard or recalibrating an instrument that is showing repeated problem. Statistically based limits will only be applied when the control limit range is at least as tight as the appropriate regulated or EPA-approved method-specified range. See the analytical SOP for specific details.

Upper and Lower Control Warning Limits = 2 sigma Upper and Lower Control Limits = 3 Sigma (used for in-house limits)

Where: y = each individual value used to calculate the mean y = the mean of n values

n = the total number of values

8.7 Estimation of Uncertainty

Estimation of Uncertainty consists of the sum (combining the components) of the uncertainties of the numerous steps of the analytical process, including, but not limited to: sample plan variability, spatial and temporal sample variation, sample heterogeneity, calibration/calibration check variability, extraction variability and weighing variability.

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Estimation of Uncertainty in Measurements (Laboratory portion) shall be provided to clients upon request. Calculation of this uncertainty estimation may be done using the “Quality Control-based nested approach Uncertainty Spreadsheet” (DoD Navy Document). For those analyses that do not include all the QC types needed to use the nested approach (i.e. various Inorganic analyses), the standard deviation of 20 LCS points may be multiplied by a factor of 2 to achieve the uncertainty estimation.

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9.0 Data Reduction, Validation, Reporting and Records

9.1 Data Reduction and Validation

Data generated from the analyses of samples is reduced according to protocols outlined in each operational department’s SOPs and the SOP for Departmental Validation Procedures. Each data reduction process for each laboratory is slightly different, but all follow a similar core procedure. The instrument operator first reviews the data generated at the instrument. This includes review of raw data and verification of all method and project specific QC requirements. In addition, the operator is responsible for adding data flag qualifiers and a notation on the bench sheet of any unusual situations or observations. The operator has a variety of data and format checker programs to aid in review. The data is uploaded automatically from the instrument to a Laboratory Information Management System (LIMS). Data undergoes 100% review by the analyst and 100% validation by the manager. The final validation is done by the Laboratory Director, or their designee, who reviews the data for overall quality/administrative completeness and signs off on the report. All laboratory samples undergo this procedure. In addition, clients that request data deliverable packages are subject to the review detailed in section 10.3.

No results may be released in any form unless the work has undergone the validation procedures as described below, up to and including, the team validation step. The transmissions of any results subsequent to final validation are identified as a draft or are qualified by the following statement: ‘Please Note: Data contained within this report has undergone primary validation but may be subject to change pending final validation and QC review.’

Data validation occurs at each step during sample processing.

Sample integrity is documented in Sample Reception (i.e. containers, preservation, and temperature). All criteria listed on the Sample Integrity Form is documented and initialed by Sample Department personnel.

Once the information has been logged into the LIMS, another member of the Sample Department verifies the information entered into the LIMS against the Chain of Custody. This step insures that all information, including collection date and time, matrix, preservation, due dates and special instructions have been entered into the LIMS system correctly. The Quality Services Deputy Director oversees this process.

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Each analyst verifies the information on the sample container against the bench sheet or applicable backlog. The analyst must initial the bench sheet, indicating that the sample information has been noted and is correct and that the method hold-times have been met. In addition, the analyst is indicating that method guidelines have been met and that quality control is within criteria. Other items checked include the data file upload, result accuracy, dilutions, surrogates, and, if applicable, sample qualifiers. Electronic signatures may be used to denote analyst review of raw data. Access to electronic employee signatures is controlled by employee ID and password. An electronic signature is considered equivalent to a hand-written signature. Once data is entered and reviewed in the LIMS the status is updated to analyst reviewed.

The Department Manager or Assistant Manager will validate the batch for quality control/quality assurance, accuracy, data consistency and proper use of applicable data qualifiers. Each work order will be checked to ensure that regulatory limits have been met. In addition the Manager will verify that only requested compounds are reportable and ensure that the proper results have been selected. The Manager or Assistant Manager will sign the bench sheet indicating this review has been conducted and update the status of the samples to Validated in the LIMS.

The Quality Service Department will check all information on the report for accuracy against the chain of custody. Once again, the data listed on the chain of custody will be compared to the information logged into the LIMS. All special requests (i.e. method detection limits, specific methods and special sample requirements) will be checked against the final report. In addition, the Quality Service Department will verify that all forms (i.e. state report forms, VPH, CAM or RCP forms) are accurately completed and attached to the final report.

The Laboratory Director, or their designee, will review the final report for overall data quality and consistency. The Laboratory Director will sign all reports and pertinent forms. In the Laboratory Director’s absence, authorized senior management will review and initial the report with the Laboratory Director’s electronic signature. Higher management has access to only their own electronic signature on the network for signing electronic documents. Authorized senior management has access to the laboratory director’s signature solely to sign lab reports in their absence. The status of the samples will then be updated in the LIMS to Reported.

Each step in the data reduction and validation procedure can be tracked through the audit trail in the LIMS.

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9.2 Report Format and Contents

The results of each analysis are provided in a report and include all of the following information.

Name and address of laboratory

Each laboratory report is uniquely identified by the work order number, and the date and time of report issue. The pages of each laboratory report are identified as the number of the total report pages.

Name and address of client, project name and contact person

Identification of the samples including client sample identification

Date and time of sample receipt and sample collection (if needed for analysis with a holding time of 48 hours or less)

Date of sample preparation/extraction and analysis

Identification of test methods used

Sample and/or analyte qualifiers

Correct reporting units (i.e. ug/L, mg/Kg, mg/Kg dry, ppbv, etc.)

Method MRL (adjusted for dilution factors and/or, if necessary, % solids)

Identification of all analyses supplied by subcontracted laboratories

A listing of current laboratory certification is maintained in the LIMS. This information is pulled through onto the laboratory report in the form of a checkmark in the certification column on the laboratory report. A checkmark denotes the laboratory was currently certified for the analysis/analyte at the time of analysis.

The signature and title of the person accepting responsibility for the content of the laboratory report

A statement that the laboratory report shall not be reproduced except in full, without the written approval of the laboratory

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The transmission of any tests results, in any form, including electronic, will be within the guidelines described within this section and section 1.2 to insure that confidentiality is preserved.

Amendments made to any analytical report after issue is made only in the form of a further document, which includes the statement “Revised Report”.

Drinking water samples submitted for total coliform analyses that show a positive presence are confirmed for E.coli. Clients are notified immediately by both telephone and, if applicable, facsimile or e-mail, to notify them of the positive result. They are informed to not use water from the sample source until disinfection and confirmation for negative coliform has been performed.

Clients are also notified via facsimile or e-mail of all National Primary Drinking Water Exceedances or results that identify the presence of regulated microbiological organisms in Potable Water. Eurofins Spectrum Analytical will ensure Potable Water samples of the following:

Upon obtaining valid sample data, Eurofins Spectrum Analytical will notify its clients of the results of all samples that exceed any EPA or MADEP-established maximum contaminant level (MCL), maximum residual disinfectant level or reportable concentration, or that identify the presence of regulated microbiological organisms in potable water. The notification will clearly indicate that a regulatory limit has been exceeded. The date, time, and manner of notification will be documented and kept on file with the lab. Eurofins Spectrum Analytical will notify its client public water systems of the results of all samples that exceed a regulatory limit. Data indicating an exceedance of a regulatory limit will be validated and the validated data reported as soon as possible, not to exceed 24 hours after the completion of sample analysis. This includes non-regular business days. Notification will be given within 24 hours of the completion of the analysis of the sample whether or not the sample was subcontracted to another laboratory. Eurofins Spectrum Analytical Subcontract Work Orders will identify, in writing, those samples needing special reports (e.g., MCL exceedance) and date results are needed by. See section 15.1 for a full description of our Subcontract Work Order procedures. Eurofins Spectrum Analytical will make every effort to ensure that analytical data, analyzed for the purpose of determining regulatory compliance, are reported in a timely manner to meet their clients’ reporting requirements. Regulatory compliance samples subcontracted to Eurofins

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Spectrum Analytical from another laboratory will be reported to the client laboratory within the timeline pre-arranged by the two laboratories.

Laboratory reports for finished drinking water samples note the maximum contaminant level, maximum residual disinfectant level, secondary maximum contamination level and/or Massachusetts Office of Research and Standards Guidelines (ORSG). See www.mass.gov/eea/agencies/massdep/water/drinking/standards/standards-and-guidelines-for-drinking-water-contaminants.html for additional information.

9.3 Records and Document Control

Chains of Custody forms, bench sheets, hand-written logs and other original documentation are scanned and saved electronically for easy access. All original, hardcopy records are physically archived for a minimum of five years, per Eurofins Environment Testing US policy. Electronic files are backed up by the IT department. Data that has been archived (i.e. no longer in direct possession of the applicable department) is controlled by the IT department or senior management. Laboratory personnel may view electronically archived data via a searchable, read-only archive. Direct access to electronically archived data that involves moving or restoring files is restricted to IT only and documented by an access log. Access to physically archived hardcopy data is restricted to authorized senior management and documented by an access log.

All sample data produced is written to the file server. This data backed up onto magnetic tape daily and remains on the file server for a two month time period. After which, the files are backed up onto 4.7 GB DVD-R discs monthly as defined in the SOP for Laboratory Computers.

One copy of each monthly backup disc is stored in the IT Department at the Silver Street facility. The other copy is stored in a fireproof cabinet by the Laboratory Director at the Almgren Drive facility. The discs are kept for a period of ten years. The IT Manager is responsible for all data archiving, maintenance and retrieval.

All instructional materials posted within the laboratory space are subject to Eurofins Spectrum Analytical’s document control system. A controlled copy of the document is issued by the Quality Assurance department and a record of the document name, any relevant page numbers, the issue date and its location is maintained. Posted instructions are reviewed by the applicable department on an annual basis for accuracy. Posted materials that are not instructional in nature are exempt from the document control policy. Examples of exempt materials include non-instructional posters, regulatory limits, notes regarding sample preparation

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status such as what time a step will be completed, reminders not related to an analysis such as to check that doors are closed, current lot numbers of reagents in use and instrument out-of-service signs. Postings of an instructional nature would include excerpts from SOPs, checklists, calculations, method criteria, reminders that apply to an analysis such as how long a leachate sample may rotate, logbooks and emails with directions how to handle a sample or project. ESA-MA personnel may consult the QA department with any questions if a document is instructional in nature.

9.4 Transfer of Records

In the event Eurofins Spectrum Analytical (Agawam, MA Division) changes ownership or closes, the transfer of ownership of client records would be required.

If Eurofins Spectrum Analytical transfers the ownership of the laboratory to a new owner, ESA-MA would expect that record retention would be negotiated and made part of any purchase contract, and that the new company would maintain all required NELAP and other certifying agency documentation. The responsibility for maintenance, control, storage and eventual disposal at the end of the appropriate time period, of all records, including client data and QA/QC files, will transfer to the new owners. Since NELAP and other agency certification would likely be one of the attractive aspects of the laboratory to a purchaser, it is unlikely that a new owner would not want to maintain the appropriate records and certifications. In the event a new owner did not want to maintain past records, Eurofins Spectrum Analytical would notify all clients and make these records available to them for a reasonable fee. Clients would be given a minimum of 30 days to determine if documents are needed or not.

In the event Eurofins Spectrum Analytical decides to cease operations, clients will be notified prior to the cessation of operations and their files/records will be made available to them for a reasonable fee. Clients would be given a minimum of 30 days to determine if documents are needed or not. If the client determines they do not want to maintain the records, these will be disposed of properly.

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10.0 Performance and System Audits

Both the internal and external audits are conducted regularly to maintain the quality objectives of the laboratory, to develop analysts’ proficiency and to evaluate management performance. Internal audits are conducted throughout the year and managed by the QA Manager. External audits are initiated by clients in the form of spiked samples or by other outside agencies through proficiency tests and on-site assessments.

10.1 External Performance Audits

Eurofins Spectrum Analytical performs all necessary external audits to meet NELAP, DoD and State certification requirements. On occasion external performance audits are in the form of Proficiency evaluation samples submitted by clients as regular samples. In addition we perform the following scheduled performance studies:

Air (AE), Water Supply (WS), Water Pollution (WP) and Soil/Hazardous waste studies are performed twice a year as indicated in the TNI Standards. In order that we may report multiple methods, Eurofins Spectrum Analytical uses an approved commercial vendor for all chemical PT studies.

Microbiological PT studies are performed for the New York Environmental Laboratory Approval Program. In addition, an approved commercial vendor is used to meet the criteria of the Massachusetts Department of Environmental Protection.

All PTs are treated in the same manner as client samples, including being logged into our LIMS, assigned to staff, analyzed and reported. PT reports are submitted to our various accrediting agencies within 21 days of the study closing. Any Unacceptable PT results are investigated for the cause and a detailed corrective action with root cause analysis is presented, as required by the TNI Standards and the DoD QSM. Upon completion of the follow-up audit and within 30 days of the final study report being issued, copies of all PT corrective action reports are forwarded to our accrediting agencies as required.

10.2 External System Audits

State certification officers, other laboratories, and potential clients regularly audit Eurofins Spectrum Analytical. Any state that ESA-MA holds certification in or is currently obtaining certification from is eligible to conduct an audit at any time during normal business hours. Notification of a scheduled audit is requested to ensure that staff is available.

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Each department manager and the QA Manager record deficiencies noted during an audit. Corrections are made to comply with the regulations. Upon receiving the results of any audit, a meeting of all department managers is arranged to discuss the results. Unsatisfactory results are addressed and corrective actions presented. Any modifications that were initiated due to the audit are finalized as part of the new QA/QC procedure and are included as a revision to the appropriate SOP. This ensures compliance with the agency-mandated regulations.

10.3 Internal Performance Audits

The QA Department conducts an annual Internal Audit according to a schedule issued at the beginning to the year. Any changes to the schedule must be documented along with the reason why. The Internal Audit reviews all aspects of our quality system from sample pick up through the entire analytical process. Audits are conducted in addition to the daily QA procedures. Audits reflect laboratory performance under normal operating conditions. This review may include the analysis of blind samples. Blind samples submitted for the audit are prepared by the QA Department or purchased through an approved vendor. The samples are logged in under a fictitious client. The Laboratory Director and QA Department are the only personnel aware of the audit samples. The QA Department compiles all data and submits an audit report to the Laboratory Director. If requested, the Laboratory Director and/or the QA Manager will hold a meeting with the department managers to discuss the results and any corrective actions that may be necessary. The results and any necessary corrective action reports are then filed with the QA Department. The QA Department itself is audited by a third party to ensure impartiality. This audit covers documents control, corrective actions and their effectiveness, review of data packages for completeness and accuracy, and compliance with regulatory agencies and internal policies.

In addition to the annual Internal Audit, Observational Audits are performed on a regular basis. Each month, the QA Department selects an analysis from each operational department for review. The auditor observes the analyst performing the analysis to ensure they are following all steps in accordance with the SOP and method. The results and any necessary corrective action reports are then filed with the QA Department.

In depth laboratory performance monitoring is also done on a continual basis by the review of data deliverable packages. ESA-MA routinely provides these packages to clients, which includes Sample Receipt Documentation, CLP-like summary forms, copies of instrument calibrations, raw Batch QC and sample data, standards preparation sheets, analytical run logs, laboratory bench sheets and a case narrative. At a minimum, 10% of all level 4 data deliverable packages are

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thoroughly reviewed for technical completeness and accuracy. Packages are prepared by the analysts, reviewed by the departments and reviewed again by the QA manager or a designee from sample receipt to the final report. The Quality Assurance department monitors that method requirements are being strictly followed. Any QC failures, deviations or analysis issues are thoroughly documented in the case narrative and noted by the QA department.

A client question regarding their results will prompt an investigation by the QA department. Clients are informed of the results of the investigation and if their data is affected in any way. If a quality issue is detected, a corrective action is presented and the client is notified within three business days or sooner.

10.4 Internal System Audits

The Managerial Team conducts internal system audits a minimum of once per year to ensure that all departments are operating accurately and observing all QA requirements. The following items are verified during an internal system audit:

Standard Operating Procedures being followed

Computer system/network archival done on schedule

LIMS is inspected to ensure the integrity of electronic data

Chemical hygiene/safety practices being followed

Sample handling/storage/disposal practices followed

Logbooks recorded and stored in correct manner

Gas storage and inventory kept according to internal policy

Department managers are apprised of any deficiencies in their department detected during the internal system audit. These are recorded and discussed at the next management team meeting. Corrective Action Reports issued for Internal Systems Audit deficiencies are documented and filed with the QA Department.

10.5 Management Review

Results of both internal and external audits are verified by the QA Manager and submitted to the Laboratory Director for final review. Any data that falls outside established acceptance criteria results in an investigation. The outcome of the investigation, along with suggested corrective actions, is documented and submitted to the Laboratory Director for review and final action. A follow-up

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audit is done afterwards to ensure that the corrective action has been implemented and is effective. A response indicating corrective actions to be taken may be required when errors or deviations are found in proficiency tests or during laboratory audits. Reports generated in response to external audits will address any problems found and the corrective actions to be taken. These will then be submitted to the agency conducting the audit, if applicable, and all appropriate laboratory departments for implementation.

On an annual basis all Standard Operating Procedures (SOPs) are reviewed by departmental management and modified as necessary for continuing suitability and effectiveness. Method SOPs are compared to the method being performed upon annual review. The outcome and corrective actions from all internal audits and assessments from external bodies are included in a Memo to the laboratory director. The resulting corrective actions are reviewed at a minimum annually to ensure they are being enforced. The following items are recorded and addressed weekly in the Weekly Performance Meeting: feedback from clients, complaints, changes in the volume & type of work undertaken, resources, staffing and training. All departmental managers are reviewed on the QA activities of their department within their annual performance review. The objective here is to continually improve the effectiveness of the management system.

The laboratory director in conjunction with the QA staff, taking the following factors into account, prepares an annual Management Review:

Suitability of SOPs, policies and procedures; Reports from weekly performance meetings, internal audits and departments manager’s updates Clients feedback and complaints; Reports from external audits; Corrective Action Reports PT results; Changes in volume and type of work; Recommendations for improvement; Other relevant factors such as quality control activities, resources and staff training;

The Annual Management Review report will be discussed at a meeting with the Laboratory President, Director, QA manager, corporate President and corporate QA Director. Action items from the Management Review are recorded and addressed within an agreed upon time frame. If any actions are not completed within that time frame, the reason for an extension will be documented.

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11.0 Facilities, Equipment, Reagents, and Preventative Maintenance

ESA-MA utilizes two state-of-the-art facilities in Massachusetts that include high-tech instrumentation and data processing equipment for organic, inorganic, wet chemistry, microbiology and mixed waste. All electronic data is controlled by ESA-MA’s Laboratory Information Management System (LIMS). Laboratory personnel access the LIMS database via individual usernames and passwords at computer terminals located throughout the facility.

After hours access to the building is restricted to authorized personnel only. The burglar and fire alarms are monitored by an outside security agency, which will contact the appropriate laboratory personnel and local agencies in the event of an emergency. Each employee has a personal identification code for after-hour entry and exit through the main entrance.

The heating and cooling environmental controls activate and deactivate automatically to maintain temperature control in each of the separate building zones. All temperature critical equipment, such as refrigerators, freezers, incubators, analytical instrumentation, and ovens are monitored regularly to ensure proper and consistent temperature. All refrigerators, freezers, incubators and select ovens are monitored by electronic probe thermometer 24 hours a day/7 days a week. Temperature readings are recorded hourly with two consecutive readings recorded at 6:00 & 6:30 AM and at 7:00 & 7:30 PM to monitor performance. If either of the two consecutive AM or PM readings are outside the acceptance limits, an email alert is sent to upper management to ensure that any needed service is conducted promptly. During unstaffed hours (evenings, weekends, holidays), temperature exceedances will trigger a phone alert system that texts assigned personnel who will come in to address any out of control situations. Readings are documented in the laboratory’s Temperature Probe Program; specific details can be found in the laboratory’s SOP. Electronic probes are calibrated quarterly against a NIST certified thermometer.

Each operational department (volatile, semivolatile, inorganic, wet chemistry, microbiological) has separate rooms, which are equipped with fume hoods, chemical storage cabinets, and all required safety equipment.

Eurofins Spectrum Analytical’s management team is dedicated to providing a healthy and safe working environment for all employees and visitors by taking all necessary measures to achieve and maintain compliance with Occupational Safety and Health Administration (OSHA) standards. The OSHA Hazard Communication SOP and a complete Health and Safety Plan is available upon request.

11.1 Laboratory Facilities

11.1.1 11 Almgren Drive – Agawam, MA

This building consists of approximately 12,000 square feet utilized by the Sample Login,

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Semivolatile, Inorganic, Wet Chemistry and Microbiology Departments, in addition to a training center and cafeteria. For security reasons, floor plans may only be viewed onsite.

11.1.2 830 Silver Street – Agawam, MA

A 10,000 square-foot building, located at 830 Silver Street, Agawam, houses the following departments: all administrative offices to include: Laboratory Director, Marketing, Quality Service Department, Quality Assurance, Accounting, IT Departments and two state-of-the-art laboratories; namely the Volatile Organic Department and Air Division. This building is 1500 feet from our 11 Almgren Drive location. For security reasons, floor plans may only be viewed onsite. The following description indicates the square footage of the two operational departments at this location.

11.1.2.1 Volatile Organic (VOC) Department

An area consisting of 1,037 square feet houses a new state-of-the-art VOC Laboratory. This area has counter tops, hoods, proper ventilation and assigned cubicles for analyst’s data processing.

11.1.2.2 Air Laboratory

An area consisting of 610 square feet houses a new state-of-the-art Air Laboratory. This area has counter tops, proper ventilation, explicit piping for the instrumentation and cubicles for analyst’s data processing.

11.2 Laboratory Reagent Storage

Laboratory reagents are stored according to the chemical hygiene plan (available upon request). All storage areas are properly ventilated and meet all safety guidelines. All reagents are labeled with the date received. See Table 11.1 in Appendix G.

11.3 Equipment and Reference Materials

Records are kept for each piece of equipment in the laboratory. Logbooks are kept for each instrument to document maintenance performed. Detailed records are kept by the administration, which include such information as serial numbers; dates received and date placed in service. All laboratory logbooks (both hardcopy and electronic) are peer reviewed for completeness, accuracy, proper format and documentation of corrections on a periodic basis.

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Please refer to the specific analytical SOP for hardware maintenance and troubleshooting and the IT SOPs for software maintenance.

11.4 Documentation and Labeling of Standards and Reagents

Standards and reagents are entered into the LIMS and printed upon receipt. Recorded are vendor name, date of receipt, expiration date, and lot number. The standard pages can be retrieved from the LIMS. In addition all certificates of analysis received from vendors are scanned into the LIMS with the associated unique standard/reagent ID assigned by the LIMS. Reagents are kept in their original containers whenever possible. If transferred, they are put into clearly labeled containers and marked with name of reagent/standard, date received, date opened, lot number, concentration, and expiration date.

All standards and/or reagents used for calibration are either ISO certified or certified by the supplier through analysis with EPA certified or NIST traceable weights and measurements. The commercially prepared standards require dilution to the working concentration. Comparing the new working level concentration against the previously prepared lot checks the accuracy of the dilution. The preparation of working standards may be tracked through the Standard Preparation Logbook by date of preparation. The analyst preparing the working standard records the weights, volumes, concentrations, vendor lot number of neat standards, type of solvent used, initials, date of preparation and date of expiration. The vendor reference codes may be cross-referenced to the logbook/LIMS that lists receipt of all standards and reagents received into the laboratory.

Working level volatile standards are prepared weekly. Semi- volatile stock standards are prepared every seven weeks and working level standards are prepared every four to six weeks, as needed. Pesticide stock standards are prepared yearly and working level standards are prepared every two to four weeks, as needed. Alachlor stock standards are prepared yearly and working standards prepared approximately every two to three months.

11.5 Computers and Electronic Data Requirements

ESA-MA’s data is managed by a laboratory information management system (LIMS) called Element DataSystem, produced by Promium. It manages the data for all samples being processed by the lab, and operates on a Microsoft SQL Server.

The LIMS is an all-inclusive data management system for the lab. Each sample is logged into the system upon receipt, and the LIMS tracks its progress as it travels throughout the lab. Backlog reports, QA/QC data reporting, data import from the instruments and final client reports is all possible using the LIMS. A detailed

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instruction manual on its use and operation is available in the IT Department. Clients would be notified of any software updates or changes to the LIMS configuration that could adversely affect their electronic data.

The LIMS also features configurable user rights and privileges, which protect data from accidental damage by an employee. Each employee is given only rights to the portions of the program that they need to complete their job. This ensures that no employee can change or manipulate data that they do not have the responsibility to change.

Internet access is made available exclusively to administrative personnel for research purposes. This research may consist of access to the DEP, other regulatory agencies, or instrument manufacturers. Internet access also allows for e-mail communication with clients, and allows ESA-MA to serve their website on an in-house server.

In addition to hard copies, clients with email access can receive final reports and Electronic Data Deliverable (EDDs) in a variety of electronic file formats. These include Microsoft Access, Excel, Word, PDF, and simple text. These files are automatically generated by the LIMS. Clients may request EDDs in customized formats. The IT Department reviews specialized EDD formats and tests the deliverables using data and format checkers to ensure accuracy. Example EDDs may be sent for client approval prior to implementation.

Raw data created by the instruments is organized by month and stored on the file server. Each month, the IT Department is responsible for archiving one month’s worth of data as part of the backup procedure. All data produced within the last two months remains on the file server at any given time.

All vital computer data is backed up nightly to both onsite and removable media. This includes all data from the LIMS database, file server, accounting software database, and web server.

11.6 Preventive Maintenance

The operational condition of instruments is one of the keys to successful completion of analytical tasks. ESA-MA commitment to instrument maintenance assures clients that equipment will be available to generate the required data

Each department has their own contingency plan as well as backup instrumentation, which virtually eliminates downtime. In order to prevent any possible cross contamination, instruments that are dedicated to volatile compound detection are physically separated from all other laboratory departments.

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Preventive maintenance as well as major instrument repairs can be accomplished on site. An in-house stock of critical spare parts allows for complete and rapid repair. ESA-MA maintains service agreements with instrument manufacturers to further assure the operational viability of all in-house equipment. In case of major equipment failure, approved subcontractor laboratories are available to perform analyses on short notice.

The hardware tunes and calibration of the instruments are documented in the instrument logbooks kept in each area. If an instrument fails tuning or calibration criteria, hardware adjustments and/or appropriate maintenance is performed and documented. The analyst repeats the tune and calibration attempt. If the second attempt is successful, this is noted in the sequence logbook and sample analysis may proceed. Sample analyses may not proceed without an acceptable calibration.

Qualified senior analysts perform routine preventive maintenance adeptly as part of the training program. A vendor-provided manual outlining the proper use of each instrument is maintained within the operational department. Included in these manuals are procedures for calibrating and performing preventive and routine maintenance.

Preventive maintenance checks and services required for all instrumentation may be found in the specific SOP. Maintenance log books and service records are maintained permanently in each department.

Ancillary equipment, balance, ovens, refrigerators, etc. are monitored and maintained on a daily basis to assure operational readiness.

11.7 Inspection/Acceptance Requirements for Supplies and Consumables

Chemical standards are ordered and received from various vendors and are examined for damage or missing ampules. Each standard is individually logged into the LIMS indicating the date received, vendor, product name, lot number and expiration date. All packaging slips are also initialed for accuracy and maintained with the accounting department. The Certificate of Analyses is scanned into the LIMS and attached to the assigned Standard ID number. The Material Safety Data Sheets (MSDS) are then given to the Health and Safety Manager and filed in a binder for right-to-know purposes. All chemicals used within the laboratory (such as methylene chloride, hexane, etc.) are checked for damage and missing items and are then released to the manager of the department for their use.

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12.0 Routine Procedures Used to Evaluate Data Quality

Acceptance criteria used are established within the specific method, or by Eurofins Spectrum Analytical’s QA Department. Eurofins Spectrum Analytical may establish acceptance criteria for any method performed that does not have recommended acceptance ranges. If QC data falls outside the acceptance range the information is documented and the QC standard must be rerun to verify that all data analyzed is valid.

Quality control samples used to verify the data include method blanks, laboratory control spikes, calibration check samples, matrix spikes, matrix spike duplicates, and field duplicates. See Table 12.1 in Appendix H for Concentration Levels for QC Samples.

12.1 Method Blanks

A method blanks is prepared at the frequency specified by the reference method. The purpose of the method blank is to ensure that the glassware, reagents, standards, and personnel or sample preparation environment do not introduce contaminants. For volatile analyses an instrument blank is analyzed during each sample set to confirm that contaminants are not being introduced by components of the instrumentation or the analytical laboratory. See Table 12.2 in Appendix H for QC Frequency of Method Blanks.

Laboratory Control Samples, Blank Spikes, Standard Reference Material and Calibration Checks

Most Laboratory control samples are analyzed at a continuing frequency equivalent to 5% of the samples of the analytical set (i.e., one every twenty samples). The data is reviewed and entered into the LIMS as part of the QA procedure. See Table 12.3 in Appendix H for the QC Spike Frequency.

A calibration check sample is analyzed with each batch of samples. The check sample is compared to the original curve and the relative percent deviation is calculated.

12.3 Surrogate Recoveries

Minimums of three surrogate standards are added to each organic sample requiring GC/MS analysis for volatile and acid/base neutral compounds. Samples are fortified prior to extraction, purging, and digestion or distillation. For pesticide analysis, at least one surrogate is added to each sample. Inorganic and organic matrix spikes and LCS spikes are similarly fortified with spike standard solutions containing target analytes of interest. The recovery of these standards is quantitatively measured during analysis, and historical records of the percent recovery for each sample are maintained in the control chart database. Surrogate

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and spike compound recoveries must meet acceptance criteria before the analytical data will be reported and released. In some instances the sample matrix may produce interference, which adversely affects recoveries. Surrogate recovery interference must be confirmed by preparing and analyzing the sample again for confirmation. When a matrix spike test fails spike recovery criteria, the LCS must be analyzed. If the LCS analysis fails, the batch must be reprocessed; if it passes, the matrix effect is confirmed and a QA notice qualifies the affected data. Depending on the type of discrepancy identified, corrective action may involve reporting the data as is with a laboratory qualifying notice. When an analyte does not meet criteria for RPD in inorganic duplicates, a data qualifying flag accompanies the analyte result in accordance with the CLP reporting convention.

12.4 Matrix Spikes and Matrix Spike Duplicates (MS/MSD)

At least one sample from a set of samples (or 5%, whichever is greater) of a similar matrix will be prepared and analyzed by a specific method. See Table 12.4 in Appendix H for MS/MSD Spike QC Frequency.

12.5 Duplicates

At least one sample in a set with a similar matrix will be selected and analyzed in duplicate. Field duplicates are run when provided by the client. See Table 12.5 in Appendix H for Duplicate QC Frequency.

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13.0 Corrective Actions

Conditions that adversely affect the quality of analyses are classified as either isolated conditions or systematic conditions. A third condition is referred to as a bias or random error. The corrective actions implemented are determined by this classification. Random errors are unavoidable circumstances, which are reflected in the unpredictable fluctuations that occur during analytical sequences.

Corrective action procedures are also referred to in each method specific SOP. Due to specifics of methodologies, the corrective actions for quality control issues for microbiology are detailed in the SOPs.

13.1 Isolated Conditions

Most isolated conditions are identified during routine data validation, and are restricted to single samples, batches, or data reports. Data validation includes surrogate and spike standard recoveries, relative percent differences between duplicates, internal standard response variations, and method blank contamination. If the quality control acceptance criteria are exceeded, the corrective action is limited to the affected sample or batch. (See Tables 13.1 through 13.4 in Appendix I)

13.2 Systematic Conditions

Systematic conditions adversely affect entire analytical systems, projects, data integrity, sample integrity, security and safety. These assessments are made by the Laboratory Director or QA Manager during review of summary QA/QC reports or during an internal or external audit. An unacceptable result on a Performance Evaluation (PE) study or internal blind study may also be an indication of a systematic problem. The following is a list of other sources of systematic conditions:

Variations in temperature on successive days in a sample storage refrigerator

Unsatisfactory spike recoveries on multiple laboratory control samples

Glassware, sample or standard storage contamination

A noncompliance with SOP

Deviations in documentation or procedures

Obliterations, write-overs, or other improperly corrected data

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Expired standards in the refrigerator

Open or unlabeled waste containers

Inadequate hood velocity

Recurring, inconsistent conditions observed on control charts

Unsatisfactory internal quality checks for positive and negative controls for microbiological analysis

The systematic conditions are documented and corrective actions are initiated. This indicates who is responsible for correcting the problem, the root cause of the problem, what action is taken, and a date for implementation. If client data is affected, all applicable clients are notified within three business days or sooner from the discovery of the issue. The noncompliance issue is closed once laboratory management has determined that all corrective actions are in effect.

For failed proficiency test results managers are responsible for determining why the parameter failed and, if necessary, implementing revised procedures to ensure the error does not occur again. In the case of analyst error, the managers must document specific details and may have the analyst repeat precision and accuracy and initial demonstration of capability studies.

Any changes to approved corrective actions developed to address findings during DoD assessments must be approved by DoD accreditation body.

13.3 Instrument Checks

Initial calibration verifications (ICV) are analyzed after the initial calibration and prepared from a source different than used for initial calibration. An acceptable ICV must be obtained before sample analysis can begin. They verify the accuracy of the calibration. If the percent recoveries of the known analytes do not meet the method or ESA-MA’s internal QC requirements, the following procedures are implemented:

Locate and correct source of the problem

Reanalyze the ICV

Recalibrate the system

System and solvent blanks are run before any samples to ensure that the system is functioning properly. This also ensures the system is free of contaminants. If the

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blank fails, another will be run. If the blank fails a second time, the following corrective actions will be taken:

A notation will be made in the sequence logbook

Check the reagent blank for background/cross contamination

Check deionized water for contamination

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Check if quantitation procedures are properly followed (i.e., retention times, peak areas, response factors, internal standard references)

Rerun QC standard from the same batch to determine if the problem was because of the analyst’s performance or instrument malfunction

Run a fresh QC from a different standard to verify the calibration

Recalibrate the system

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13.4 Departure from Documented Procedures

The Laboratory Director and Quality Assurance Manager have the right to deviate from documented Standard Operating Procedures. This may occur when the normal corrective action procedures are not followed due to the type of analysis or clients needs. All deviations are noted on bench sheets for record keeping purposes. An example of when this may occur is if a client is trying to determine field-type qualitative data rather than quantitative results. These deviations are documented and the client is notified of laboratory procedures prior to data being released. All associated work orders are narrated in the final report.

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14.0 Review of Requests, Tenders and Contracts

All proposed plans for new work are directed to the Quality Assurance Manager, the plan is then reviewed in its entirety. The plan is broken down to the appropriate management staff to ensure that the requirements of the plan can be attained.

14.1 Distribution of project plan among Management Team.

Quality Assurance Manager reviews that all required certifications and quality controls can be met. The Quality Assurance Manager also reviews any necessary Quality Assurance Manuals and certifications from subcontract laboratories.

The Laboratory Director, Operational Support Manager and Department Manager reviews the organic requirements to ensure that instrumentation, personnel, methods, analyte lists and detection limits can be met. The Laboratory Director, Operational Support Manager and Department Manager determine and initiate any calibrations, standards, MDL studies and proficiency testing if necessary. If project data quality limits are not specified, current laboratory reporting limits will be applied.

The Laboratory Director and Department Manager reviews the inorganic requirements to ensure that instrumentation, personnel, methods, analyte lists and detection limits can be met. The Laboratory Director and Department Manager determine and initiate any calibrations, standards, MDL studies and proficiency testing if necessary.

Laboratory Director assesses the number of samples and analyses to determine an appropriate turn around time sufficient to the required quality control parameters of the project. The Laboratory Director and Courier Manager also oversee sample pickup and glassware requests for new projects.

Deputy Director of Quality Services reviews any reporting formats or electronic data deliverable (EDD) necessary for the project and provides pricing to the client. If changes are necessary from our standard format, the Deputy Director of Quality Services will coordinate with the IT Manager to make the changes. The Deputy Director of Quality Services reviews all analyses for sub-contract. The sub-contract laboratory certifications and Quality Assurance Manual are verified at this time and updated if necessary. See Section 15 for Laboratory Sub-Contract procedures.

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14.2 Results of Review.

a. Based on the final review of the Management Team, the client is notified of any potential conflicts, deficiencies, lack of appropriate accreditation status or any other inability to meet the client’s request. This notification will occur in writing or by telephone. Once conflicts have been resolved, final agreements will be documented in writing. The Laboratory Director makes the final decision for work to commence.

b. If all project requirements can be accomplished, the Laboratory Director makes the final decision for work to commence.

c. If a contract needs to be amended after work has commenced, either by the client or by changes within the laboratory, the same contract review process shall be repeated and any amendments shall be communicated to all affected personnel.

14.3 Record Maintenance

a. The Quality Assurance Manager maintains records of review and Quality Assurance Project Plans.

b. All other documents are held within the office of the Laboratory Director.

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15.0 Subcontracting and Support Services and Supplies

15.1 Subcontracting Laboratory Services

Any analyses not performed by Eurofins Spectrum Analytical will be sent only to an approved subcontract laboratory certified for the analysis. This includes ensuring that the subcontracted laboratory holds the appropriate certification, when certifiable, for the type of samples; for example: DoD, ISO or NELAP accreditation. The selection of subcontractors is approved upon evaluation conducted by the Laboratory Director, Quality Assurance and Quality Service Departments in order to ensure quality, deliverable, and service. When a new subcontract laboratory is selected, Quality Services enters the sub lab’s information into LIMS but leave the status inactive until all documentation is received. The Quality Assurance Department initiates a request to the sub lab for all the required documentation. Upon receipt of the sub lab’s certification and Quality Assurance Manual (if applicable), the QA Department makes the sub lab active in LIMS. The Quality Assurance Department requests that subcontract laboratories submit updated certifications and revised Quality Assurance Manuals (if applicable) on an annual basis. See ESA-MA’s SOP for Subcontracted Analyses for details.

Upon designating analyses to be subcontracted a Subcontract Work Order is generated through the LIMS. A Subcontract Work Order identifying the receiving laboratory, site location, client project number, laboratory sample id, collection date and time, number and type of sample containers, preservation, due date and the subcontracted analyses will accompany every sample. Any special reporting requests, such as State reporting forms, Data Deliverable packages, MCL exceedance reports or project specific/regulatory reporting limits will be highlighted in the comment section of the Subcontract Work Order. The following information regarding subcontracted analyses is kept on file:

A copy of the subcontract laboratory’s certification A copy of the subcontract laboratory’s Quality Assurance Manual (if applicable) A copy of the subcontract laboratory report including the Chain of Custody document.

A notation of any subcontracted analysis is documented on the final laboratory report provided by Eurofins Spectrum Analytical.

15.2 Outside Support Services and Supplies

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Eurofins Spectrum Analytical utilizes only reputable service technicians and vendors whose services meet the internal standards of quality. A listing of all support services and suppliers are kept on file and are available for review.

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Eurofins Spectrum Analytical Comprehensive Quality Assurance Manual Revisions

Revised March 2017 Section 1.2: Quality Policy Statement – Updated with current Eurofins Quality Statement. Section 1.2.3: Team Alliance Strategy and Community Support – Removed entire text and renumbered subsequent sections. Section 2.1: Organizational Structure – Christina White made Laboratory Director and removed Technical Director position. Added Senior Operations Director position and description of responsibilities. Added onsite supervision of Silver St lab to President’s responsibilities.Section 2.3: Quality Assurance Managerial Organization – Updated type and frequency of meetings. Section 2.4: List of Key Personnel and Positions – Christina White made Laboratory Director and removed Technical Director position. Added Senior Operations Director. Changed Lab Manager to Operational Support Manager and included responsibilities. Section 5.6: Sample Disposal – Changed disposal timeframe from 60 to 30 days. Section 8.2: Method Detection Limits/Reporting Limits/LOD Verification/LOQ – Removed text “For DOD projects, the requirement is that the LOQ be equal to or no greater than 3 times the LOD verification and that the lowest calibration standard determines the LOQ.”. Updated LOD and LOQ spiking criteria. Section 9.1: Data Reduction and Validation – Updated validation procedure to note managers update sample status from Analyst Review to Validated. Removed Validation Team step. Section 9.2: Report Format and Contents – Added sample preparation/extraction date/time are included on lab reports. Added detailed requirements when reporting drinking water samples with exceedances. Section 9.3: Records and Document Control – Updated record archive policy to match Eurofins US policy. Original, hardcopy records are physically archived for 5 years. Section 15.1: Subcontracting Laboratory Services – Added “due date” to information specified on subcontract work orders. Updated subcontract lab approval procedure. Replaced Technical Director with Laboratory Director throughout document. Revisions: Removed all but two most recent revision logs. Appendix B – Updated Eurofins Ethics Policy Statement and Quality Policy Statement. Appendix C – Updated organizational structure with current staff. Replaced Lab Director resume with Christina White. Appendix E – Updated Tables with current criteria for:

o Table 6.1, 524 minimum number of standards and concentration range o Table 6.1, 624 minimum number of standards and concentration range o Table 6.1, 8260 minimum number of standards and concentration range o Table 6.2, GRO separated from VPH and added specific criteria. o Table 6.3, ICP Metals minimum number of standards and concentration range o Table 6.3, ICP-MS Metals minimum number of standards

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o Table 6.3, Mercury minimum number of standards o Table 6.4, TOC minimum number of standards and concentration range

Appendix F – Updated with current SOP Master List. Appendix G – Updated Table 11.2 with current equipment inventory list. Appendix H – Updated Tables with current criteria

o Added Bromide by 300.0 to all tables. o Table 12.2, Added footnote “Note that QC frequency may vary depending on

matrix and/or specific federal or state agency requirements (as noted in QC box on Chain of Custody).”

Appendix I – Updated Tables with current criteriao Table 13.1, Added corrective action “narrate as appropriate” to all methods. o Table 13.1, Updated method blank acceptance criteria to match current limits for

TO-15, TO-18, 524, 624, 8260, VPH, GRO, 625, 8270, TPH/EPH/DRO, NJ-EPH. o Added Bromide by 300.0 to all tables. o Table 13.2, Updated LCS acceptance criteria to match current limits for TO-15,

524, TOC. o Table 13.3, Updated MS acceptance criteria to match current limits for TOC. o Table 13.4, Updated Duplicate acceptance limits to match current criteria for 524,

624, 8260.

Revised October 2016 Section 2.1: Organizational Structure - Added Lean Project Manager position and description of responsibilities. Updated Information Systems Department description of responsibilities. Replaced Wet Chemistry Manager with Raquel Thomas. IT no longer a managerial position and replaced with Joel Navaroli. Section 2.3.a: Quality Assurance Managerial Organization – Updated positions with current titles. Section 2.4: List of Key Personnel and Positions – Added Kevin White as Lean Project Manager.Section 3.6: Preventative Action – Added entire new section. Section 5.2: Sample Acceptance Policy – Added sample label and custody seal as examples. Section 5.5: Storage Conditions – Revised lab refrigerator temp range from 4oC +/- 2oCto <6°C and not frozen. Section 6.1: Equipment Calibration Information – Clarified balance weights are certified annually by an ISO 17025 accredited calibration vendor. Section 7.0: Standard Operating Procedures and Test Methods – Added ESA will not distribute proprietary SOPs. Section 9.2: Report Formats and Contents – Added finished drinking water lab reports include the MCL, SMCL and ORSG values. Section 9.3: Records and Document Control – Added archived data is monitored by an access log.Revisions: Removed all but two most recent revision logs. Appendix A – Updated website link.

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Appendix C – Updated organizational structure with current staff. Appendix D – Added example of sample label and custody seal. Appendix E: Table 6.3 – Updated chart with current ICV criteria for ICP metals and Mercury. Updated CCV criteria for mercury and Anions by 300.0. Added footnotes for Mercury and 200.7 Metals. Removed all references to 525.2 and 552.2, as those methods have been discontinued. Appendix F – Updated with current SOP Master List. Appendix H – Updated chart with current MS/MSD frequency for 608, 200.7, 200.8 and 245.1. Removed all references to 525.2 and 552.2. Appendix I – Table 13.2:

o Updated chart to see lab for specific analyte control limits for 608, 624, 625. o Updated with current BS/BSD RPD for 1664. o Updated with current BS/BSD control limit for Cyanide, 524. o Removed all references to 525.2 and 552.2.

Appendix I – Table 13.3 o Updated chart to see lab for specific analyte control limits for 608, 624, 625, o Updated with current MS/MSD control limits and RPD for 1664. o Updated with current MS/MSD control limit for Cyanide. o Removed all references to 525.2 and 552.2.

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Comprehensive Quality Assurance Manual

APPENDIX A

STATE CERTIFICATIONS

Please refer to our website for a posting of our current certifications. They are available at the following link: www.eurofinsus.com/environment-testing/laboratories/eurofins-spectrum-analytical/resources/certifications/Unc

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Comprehensive Quality Assurance Manual

APPENDIX B

SECTION 1 ATTACHMENTS

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Document Title: Eurofins' Ethics Policy Statement

Eurofins Document Reference: N/A Revision: 2 Historical Reference: N/A

Effective date : 05/01/2015 Status: Effective

Page 1 of 1

Our Company was built on the foundation of high integrity and ethical laboratory practices. To preserve this standard we have a clear expectation that each of us take personal responsibility to do the right thing and uphold the highest level of ethics and quality in all of our dealings. Here are the ethical responsibilities required of us:

• Each and every one of us is expected to adhere to the highest professional and ethical standards. Each employee commits to honest and ethical practices in all daily actions.

• No one will intentionally improperly manipulate or falsify activities in any way.

• Ethical performance and data integrity MUST supersede any other objective of laboratory operations.

• Each employee bears ultimate responsibility for the validation and accuracy of his or her documentation. The analyst’s signature signifies that the action taken to generate the data and the documentation are accurate and authentic, and confirm that all proper procedures were followed in the generation of the data in real time.

• Eurofins takes a zero tolerance stance for illegal, unethical, and improper practices affecting the testing process. Each employee is responsible for safeguarding the Lab’s ethical practices. For this reason, each employee is responsible to report any situation that may be adversely affecting the quality and integrity of the data produced.

• It is vital that all employees take responsibility to preserve our ethical business practices. Employees who know of, or witness any violation of business, quality, or data integrity policy are required to report the activity to an Ethics Officer, Quality Management, or member of Senior Management. A timely and thorough investigation will occur to remedy any situation regarding these allegations.

• Any employee who knows of or witnesses any violation of business, quality, or data integrity policy, but fails to report it will be subject to disciplinary action.

• During a thorough investigation, the Ethics Officer, and/or Senior Management, will assess the situation and resolve the matter. Since data integrity is so vital to our business practices, any employee found willfully falsifying or manipulating data will be released from employment.

• The Ethics Officer, or Senior Management, in collaboration with appropriate staff, will complete a corrective action plan addressing the root causes. The action plan will be put in place and may include additional training or changes in policies and procedures. All those involved will receive confidential communication regarding corrective action steps taken to remedy the situation.

I understand and commit to these responsibilities. I understand the critical importance of data and business integrity compliance. I realize that any infractions of laboratory integrity procedures could lead to serious consequences including employment separation, debarment, or civil/criminal prosecution. I take personal responsibility to uphold the highest ethical business practices and report any concerns to help preserve Eurofins’ integrity.

______________________________________________ _______________ _________________ Name (Print) Employee Number Company Name

______________________________________________ ______________ Signature Date

Return signed document to [email protected]

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Document Title: Eurofins US Quality Policy Statement

Eurofins Document Reference:1-P-QM-FOR-9007879

Revision: 6 Historical Reference: Form 2787

Effective date: Jul 7, 2014 Status: Effective

As an organization, all personnel are committed to high quality professional practice, testing and data, and service to our clients.

We strive to provide the highest quality data achievable by:

Following all documentation requirements; describing clearly and accurately all activities performed; documenting “real time” as the task is carried out; understanding that it is never acceptable to “back date” entries and should additional information be required at a later date, the actual date and by whom the notation is made must be documented.

Providing accountability and traceability for each sample analyzed through proper sample handling, labeling, preparation, instrument calibration/qualification/validation, analysis, and reporting; establishing an audit trail that identifies date, time, analyst, instrument used, instrument conditions, quality control samples (where appropriate and/or required by the method), and associated standard material.

Emphasizing a total quality management process which provides accuracy, and strict compliance with agency regulations and client requirements, giving the highest degree of confidence; understanding that meeting the requirements of the next employee in the work flow process is just as important as meeting the needs of the external client.

Providing thorough documentation and explanation to qualify reported data that may not meet all requirements and specifications, but is still of use to the client; understanding this occurs only after discussion with the client on the data limitations and acceptability of this approach.

Responding immediately to indications of questionable data, out-of-specification occurrences, equipment malfunctions, and other types of laboratory problems, with investigation and applicable corrective action; documenting these activities completely, including the reasons for the decisions made.

Providing a work environment that ensures accessibility to all levels of management and encourages questions and expression of concerns on quality issues to management.

We each take personal responsibility to provide this quality product while meeting the company’s high standards of integrity and ethics, understanding that improprieties, such as failure to conduct the required test, manipulation of test procedures or data, or inaccurate documentation will not be tolerated. Intentional misrepresentation of the activities performed is considered fraud and is grounds for termination.

I understand the expectations and commit to implementation of all applicable policies and procedures and to providing quality data.

Name (printed) Employee Number

Signature

Date

Page 1 of 1

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Eurofins Spectrum Analytical Comprehensive Quality Assurance Manual

Appendix B Revision 9/29/15

TYPICAL LABORATORY PROBLEMS AND UNACCEPTABLE AND ACCEPTABLE SOLUTIONS

Problem UNACCEPTABLE SOLUTION ACCEPTABLE SOLUTION

Lack of time or resources to perform testing

Making up Data or Other Information – Creating data for an analysis that was not performed or creating information that is not true.

Analytical results for all samples and quality control (QC) must be based on actual analyses performed. Documented data must match actual data. Sampling information must be based on actual sampling events.

Hold time near or past

Improper Clock Setting (Time Traveling) or Improper Date/Time Recording – resetting the internal clock on an instrument to make it appear that a sample(s) was analyzed within a specified hold time when, in fact, it was not. Changing the actual time or recording a false time to make it appear that hold times were not met, or changing the times for sample collection, extractions, or other steps to make it appear that they were performed at the correct time when, in fact, they were not.

The recorded date and time of collection, preparation, or analysis must match the actual date and time that the action was performed. Documented dates and times must represent actual dates and times. Samples exceeding hold times must be reported as such; a case narrative is recommended.

DFTPP or BFB not meeting acceptance criteria

Improper GC/MS Tuning – artificially manipulating GC/MS tuning data to produce an ion abundance result that appears to meet specific QC criteria when, in fact, the criteria were not met.

GC/MS tuning data must be generated and reported according to proper techniques without manipulation of the peak or mass spectrum. Preventive/corrective action must be taken concerning data not meeting required criteria.

Calibration or QC data not meeting acceptance criteria

Improper Peak Integration (Peak Shaving or Enhancing) – artificially subtracting or adding peak area to produce an erroneous area that forces data to meet specific QC criteria when, in fact, the criteria were not met.

Instrument peaks must be consistently integrated and reported according to proper techniques, generally baseline-to-baseline, valley-to-valley, or a combination of the two. Pear area cannot be subtracted or added to force data to meet specified criteria. Preventive corrective action must be taken on instrument data not meeting required criteria.

Calibration or QC data not meeting acceptance criteria.

Improper Calibration/QC Analysis – a) Performing multiple (more than two) calibrations or

QC runs (including calibration verifications, LCS, spikes, duplicates, and blanks) until one analysis barely meets criteria, rather than taking needed preventive/corrective action after the second failed analysis, and not documenting or retaining data for the other unacceptable data.

b) Using the incorrect (previous) initial calibration to make calibration verification data appear to be acceptable when, in fact, they were not acceptable when compared to the correct initial calibration.

c) Discarding points in the initial calibration to force the calibration to meet acceptance criteria.

d) Discarding points from an MDL study to force the calculated MDL to be higher or lower than the actual value.

a) All calibration and QC data associated with sample analyses must be documented. Preventive/corrective action must be taken and documented if calibration and/or other QC criteria are not met.

b) Acceptance of calibration verification data must be based on the correct initial calibration.

c) Calibration points can only be rejected for inclusion in the calibration curve if a known error was made or if a statistical evaluation indicates that a point can be discarded. When multiple target analytes are included in each calibration standard, it might be necessary to discard selected upper or lower points for individual target analytes. Points can be discarded at the upper end of the curve if the linear range of the detector has been exceeded. For these cases, dilute samples that exceed the highest point of the calibration curve. Points can be discarded at the lower end of the curve if the detector is not producing a response. For these cases, the laboratory reporting limit must be adjusted accordingly.

d) Data points for MDL studies can only be rejected for inclusion in the MDL calculation if a known error was made or if a statistical evaluation indicates that a point can be discarded.

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Eurofins Spectrum Analytical Comprehensive Quality Assurance Manual

Appendix B Revision 9/29/15

TYPICAL LABORATORY PROBLEMS AND UNACCEPTABLE AND ACCEPTABLE SOLUTIONS

Problem UNACCEPTABLE SOLUTION ACCEPTABLE SOLUTION

QC samples or spikes not meeting acceptance criteria

Misrepresentation of QC samples and spikes – misrepresenting QC samples or spikes as being digested or extracted when, in fact, they were not actually digested or extracted. For example: a) Adding surrogates after sample extraction rather

than prior to sample extraction.

b) Reporting post-digested spikes or duplicates as pre-digested spikes or duplicates.

c) Not preparing or analyzing method blanks and laboratory control samples (LCSs) the same way that samples are prepared or analyzed in order to make it appear that method blank or LCS results are acceptable when, in fact, they are not.

QC samples and spikes must be prepared, analyzed, and reported according to appropriate procedures.

a) Surrogates must be added prior to sample extraction.

b) Post-digestion spikes and duplicates must be reported as post-digested and must not be misrepresented as pre-digestion spikes and duplicates.

c) Method blanks and LCSs must be prepared and analyzed the same way that samples are prepared

and analyzed. Any QC results outside acceptance criteria must be reported as such; a case narrative is recommended.

Calibration or QC data not meeting acceptance criteria

File Substitution – substituting previously generated files (runs) for a non-compliant calibration or QC run to make it appear that an acceptable run was performed when, in fact, it was not.

Data must be generated and reported for actual analyses performed. Reported dates and times for all analyses must match actual dates and times. Substitution of files is not permitted.

Calibration or QC data not meeting acceptance criteria

Unwarranted Manipulation of Computer Software – unwarranted manipulation of computer software to force calibration or QC data to meet criteria, and removing computer operational codes, such as “M” flag.

Computer manipulation is allowed only for warranted reasons, and any manipulation should be minimal and traceable. Removal of computer operational codes is not permitted.

Analytical conditions for standards do not work for samples

Improper Alteration of Analytical Conditions – improperly altering analytical conditions, such as changing the instrument conditions for sample analyses from those used for standard analyses. Using different procedures to process sample data than those used for standards.

All sample analyses must be performed under the same conditions as those used for standard analyses. Any alteration of analytical conditions must be allowable under the method requirements. All sample data must be processed by the same procedures as those used for processing standard data. Any discrepancies must be documented.

Sample not analyzed at appropriate level or not reported at correct detection limit

Over dilution of Samples or Misrepresentation of Detection Limits – intentionally diluting a sample to such an extent that no analytes (target or non-target) are detected without justification as to why the high dilution was made. Reporting a detection limit that does not represent the sample analysis (e.g., not including dilution factor in sample detection limit).

Dilutions must be made on a reasonable basis, such as high concentrations of target or non-target analytes, matrix interferences, oily samples, and other components in the sample that could harm the instrument. Include details concerning the reason for the dilution in a case narrative. Sample detection or reporting limits must include dilution factors.

Noncompliance data Deletion of Noncompliant Data – intentional deletion or non-recording of noncompliant data to conceal the fact that analyses were noncompliant.

All data associated with sample collection and analysis, including any out-of-control events or noncompliant data, must be documented and retained. Preventive/corrective action must be taken and documented for any noncompliant data.

Undesirablesituation with analysis or sample; knowledge of unethical conduct

Concealment of a Known Problem – concealing a known analytical or sample problem from laboratory management and/or client. Concealing a known unethical behavior or actions from laboratory or corporate management.

Any knowledge of analytical or sample problems must be communicated to laboratory management and the client. Any knowledge of unethical behavior or actions must be fully communicated to laboratory or corporate management.

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Document Title: Comprehensive Quality Assurance Manual

Eurofins Document Reference: Not Applicable

Revision: May, 2017 Effective Date: 5/01/17

COMPANY CONFIDENTIAL

Comprehensive Quality Assurance Manual

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Nicole Leja

11 ALMGREN DR., 830 SILVER STREET, AGAWAM, MA 01001

(413) 789-9018FAX 413-789-4076

[email protected]

Summary

Over twenty years of experience working in multiple departments of a full service environmental laboratory including VOC analysis, QA/QC, customer service and operations. Diverse skills include technical aptitude, excellence at handling multiple projects at one time, and positive communication with staff and clients. Performs data correlation and validation and assists with assessing the cost-benefits for projects and proposals as well as communicating on a corporate level with senior staff from the Rhode Island and Florida divisions. Works to prepare the capital budget and reviews the monthly financial statements to evaluate company performance.

Professional Experience

Eurofins Spectrum Analytical, Inc. – Agawam, MA September 2015 President

Responsible for assisting with preparation of budget and meeting those goals for each calendar year. Responsible for profits and losses associated with business performance and ensuring operations meet internal and external expectations.

Spectrum Analytical featuring Hanibal Technology – Agawam, MA 2010 to September 2015 Laboratory Director and Vice President of Corporate Operations

Daily responsibilities include data validation and final review of reports, technical support to in-house staff and clients, and ensuring high priority jobs meet deadlines. Additional responsibilities include authorization of purchase orders, leading team manager meetings on a weekly basis, and communicating with managers regarding staff schedules and work volume. Supervises management and staff of over 85 employees and responsible for decision making in a team environment. Communicate with Laboratory Directors in the Rhode Island and Florida divisions to ensure optimum efficiency and productivity in all facilities and that corporate procedures are consistently followed.

2000 – 2010 Operations Manager Manage all operational areas of the laboratory including organic and inorganic departments, assist with technical review of documents and data interpretation with clients. Data validation and review of reports are done on a daily basis. Key member of a team that implemented changing the Laboratory Information Management Software (LIMS) in 2002.

1998 – 2000 Assistant QA/QC Officer Responsible for maintaining all state and laboratory certification for laboratory approved methods. Maintained and controlled QA Manual and all Standard Operating Procedure (SOP) manuals for the laboratory. Conducted internal audits and prepared official responses for outside audits by certifying agencies and clients.

March 1996 – 1998 Analyst and Manager of VOC Department Operated and maintained GC and GCMS instrument for the analysis of Volatile Organic compounds using purge and trap methodologies. Supervised staff and managed the daily workload for the department. Assisted the Laboratory Director with development and training for the MADEP VPH method.

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Scientific Research Council, Energy Department – Kingston, Jamaica West Indies 1994-1995 TechnicianWorked with a European based company researching methane gas technology. Operated pilot plants for anaerobic water treatment and analyzed wastewater samples. Collected and organized data with a team of international and Jamaican scientists to review and evaluate waste programs.

Education

December 1993 Holyoke Community College Holyoke, MA A.S. Environmental Science

Spring 2010 Westfield State College B.S. Environmental Science

Spring 2015 University of Phoenix MBA

Additional courses including Biology, Biochemistry, Inorganic Chemistry I and IIReferences available upon request

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CHRISTINA WHITE LABORATORY DIRECTOR

EDUCATION B.A. in Chemistry Mount Holyoke College, South Hadley, MA

Additional Biology and Microbiology classes Springfield Technical Community College, Springfield, MA

PROFESSIONAL EXPERIENCE

Eurofins Spectrum Analytical, Inc. – Laboratory Director 2017 to present Responsibilities:

Final review and approval of Microbiology data; The Laboratory Director is responsible for overall supervision of laboratory operations, overseeing all technical and administrative policies and procedures, as well as the enforcement and adherence to said policies by laboratory staff;Use tools and processes for performance measurement and benchmarking (KPIs); Assist management and staff with development of cost calculation models (using activity-based costing methodology) such as APPC and capacity modeling;

Is responsible for final data validation and approval of laboratory reports for data generated by both the 11 Almgren Dr and 830 Silver St facilities; Provide technical support and onsite supervision of the operational departments located at

11 Almgren Drive; Supervise the revision of and final approval of protocols and methodologies; Ensuring proper data deliverable and client services; Using information collected from all departments and client feedback, the Laboratory Director

must conduct a review of the laboratory’s quality system and testing activities to ensure their continuing suitability and effectiveness, and to introduce necessary changes or improvements. Prepare an annual Management Review with these findings and ensure they are assigned and carried out in an agreed upon timeframe.

Eurofins Spectrum Analytical, Inc. – Technical Director 2015 to 2017

Responsibilities:Oversee four departments Ensure data is completed accurately and in a timely manner Assist in development of methods and procedures Review data and logbooks Assist with pertinent business metrics Assist with tests when needed

Spectrum Analytical, Inc. – Inorganic Section Team Leader 2007 to 2015

Responsibilities:Oversee three departments Ensure data is completed accurately and in a timely manner Assist in development of methods and procedures Review data and logbooks Assist with tests when needed

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Spectrum Analytical, Inc. – Treatability Manager 2005 to present

Responsibilities:Adaptation of proposals to lab implementation Organization of laboratory data for projects Development of methods as needed by clients Writing project reports Supervision of 2 staff members

Spectrum Analytical, Inc. – Inorganic Manager 1995 to 2005

Responsibilities:Data validation ICP instrument troubleshooting Preparation and analysis of EPA methods Developed several methods (EPA 200.7 and 245.1) for quantitative analysis of metals by ICP and mercury analyzer Performed all quality control and method detection limit studies related to methods used Supervision of 10 staff members Member of team of professionals responsible for decision-making within the laboratory

Spectrum Analytical, Inc. 1994 to 1995 Laboratory Technician

Responsibilities:Sample extraction TPH GC (modified 8100), TPH-IR

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F:\data\comp quality assurance manual\Appendix C Section 2 Attachment Demonstration of Capability Rev 9-29-15.doc

Demonstration of CapabilityCertification Statement

Date: Laboratory Name: Eurofins Spectrum Analytical,Address: 830 Silver St, Agawam, MA 01001Laboratory Department: Analyst(s) Name(s): Matrix:Analyte / Class of Analytes: Method #: SOP Revision #:

We CERTIFY that:

The analysts identified above, using the cited test method(s), which is in use at this facility for the analyses of samples under the National Environmental Laboratory Accreditation Program, have met the Demonstration of Capability.

The test method(s) was performed by the analyst(s) identified on this certification.

A copy of the test method(s) and the laboratory-specific SOPs are available for all personnel on-site.

The data associated with the demonstration capability are true, accurate, complete and self-explanatory. (Attached Precision and Accuracy studies and/or MDL studies.)

All raw data (including a copy of this certification form) necessary to reconstruct and validate these analyses have been retained at the facility and the associated information is well organized and available for review in the QA department by authorized assessors.

______ Department Manager’s Name Signature Date

Kimberly LaPlante Quality Assurance Manger’s Name Signature Date

Section Leader or Technical Director’s Name Signature Date

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Eurofins Spectrum Analytical

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COMPANY CONFIDENTIAL

Comprehensive Quality Assurance Manual

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TERMS AND CONDITIONSDue to the high costs of media used for air sampling, the following terms and conditions are summarized below foryour information and our laboratory’s use.1. Media shall be returned in the same condition as received, if not, full replacement costs will be invoked to

client.2. Media will be returned to the laboratory within ten days of receipt.3. Media not returned to the laboratory for any reason will be charged a rental fee as described below.

Summa Canisters not returned after ten days $ 50.00 rental fee per week per canister

Summa Canisters not returned $900.00 per canister – plus rental fee

Passive Flow Controller $600.00 per controller

Stainless steel tubing attachment not returned $ 15.00 per canister

In line Air Sampling Filter not returned $100.00 per filter4. Cleaning fee for media returned unused $ 50.00 per canister

CHAIN OF CUSTODY RECORD INSTRUCTIONSGENERAL1. All applicable information must be completed.2. Forms must be completed legibly and in indelible ink.3. Any errors must be corrected by a single line strikethrough along with the date and initials of the individual

making the correction.FORM COMPLETION4. Page Numbering Enter the total number of pages and the page number of each individual page.5. Special Handling – Check whether standard or rush turn around time is needed. For rush TAT indicate date.6. Report To Enter the company name, address, phone and fax numbers.7. Project Mgr. Enter the Project Manager’s name.8. Invoice To Enter the company name, address, phone and fax numbers.9. P.O. No. Enter P.O. number to appear on invoice.10. RQN List quotation number if applicable.11. Project Number/Site Name/Location/State Enter project number (if applicable). The project name and

location/state must be completed.12. Sampler(s) Print name(s) of sampler(s) and the organization by which they are employed.13. SAMPLE INFORMATION

a. Sample ID Enter the field sample ID number(s) of each unique sample (s).b. Sample Date(s) Enter the date(s) sampled.c. Time Start Enter the start time of sample collection. Military time preferred.d. Time Stop Enter the stop time of sample collection. Leave blank for grab sample.e. Canister Pressure Start Enter pressure at time of start of sample.f. Canister Pressure Stop Enter pressure at time of end of sample.g. Interior Temp. Start Enter temperature at time of start of sample.h. Interior Temp. Stop Enter temperature at time of end of sample.i. Analyses Specify the test(s) to be requested by method number(s).j. Matrix Enter a matrix type.k. Check box if canister is returned unused Check if no analysis required for canister.

14. QA/QC Reporting Level – Check appropriate reporting level15. Temperature/Pressure Complete as necessary16. Special Instructions/QC Requirements Pertinent remarks about the sample or sample condition may be

noted as well. List any applicable limits to be met.17. SIGNATURES FOR CUSTODY PURPOSES Use as many lines as necessary to show transfer and receipt of

samples.a. Relinquished by Signature of person who relinquishes samples.b. Received by Signature of person who accepts samples.c. Date/Time List date and time of sample transfer.

18. REPORT DELIVERY Indicate whether results are to be emailed and list email address. Also indicate EDDformat if one is needed in addition to PDF of laboratory report.

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Sample Acceptance PolicyEurofins Spectrum Analytical is committed to maintaining the integrity of all samples submitted for laboratory analyses. All samples

submitted must have durable (waterproof) labels attached to each container identifying the sample ID, site location, and/or project

number and the collection date written in indelible ink and also must be accompanied by a Chain of Custody (COC) document. The COC

must include proper, full, and complete documentation, which shall include sample identification, the location, date and time of

collection, collector's name, preservation type, sample type and any special remarks concerning the sample.Samples may be rejected for any of the following reasons pending client notification:

Outside surfaces of sample containers have not been properly decontaminated after sample collection.There is incomplete or missing documentation.The identification of a sample container is questionable or unidentifiable.The sample is received outside the holding time for the analysis requested.Inadequate sample volume/amount to perform all analyses requested.The sample is preserved improperly or in an inappropriate container.There are discrepancies between the COC and sample labels.VOA vials contain air bubbles of sizes greater than 1% of the vial volume.Samples have high levels of polychlorinated dibenzo p dioxins/dibenzofurans (PSDD/PCDFs) or high levels of radiation.

CHAIN OF CUSTODY RECORD INSTRUCTIONSGENERAL1. All applicable information must be completed.2. Shaded fields are for laboratory use only.3. Forms must be completed legibly and in indelible ink.4. Any errors must be corrected by a single line strikethrough along with the date and initials of the individual making the correction.FORM COMPLETION4. Page Numbering Enter the total number of pages and the page number of each individual page.5. Special Handling – Turn Around Time (TAT) Indicate date needed.6. Report To Enter the company name, address and phone number.7. Project Mgr. Enter the Project Manager’s name.8. Invoice To Enter the company name, address and phone number.9. P.O. No. Enter P.O. number or additional information to appear on invoice.10. Quote # List quotation number if applicable.11. Project Number/Site Name/Location/State Enter project number (if applicable). The project name and location/state must be

completed.12. Sampler(s) Print name(s) of sampler(s) and the organization by which they are employed.13. SAMPLE INFORMATION It is the intent of this form that each unique sample taken from the same location at the same time be listed

per line.a. Lab Id For laboratory use only.b. Sample Id Enter the field sample identification of each unique sample(s).c. Date and Time Enter the date and time sampled. Military time preferred.d. Type Enter whether a grab (“G”) or composite (“C”) sample.e. Matrix Enter a matrix code (see codes listed on COC).f. Containers Enter number of containers provided under the appropriate container type(s).g. Analyses Specify the test(s) to be requested including any required method number(s) and analyte list.h. Preservatives Enter a preservative code in the cell above the test requested (see codes listed on COC). Indicate any containers which

were field filtered with an "F".i. Check if Chlorinated Check box if sample is collected from a chlorinated source. Note that chlorine may interfer with some test

methods and dechlorination must be performed at time of sample collection prior to the addition of any necessary preservative. Notify the

laboratory when ordering sample containers if collecting from a chlorinated source.j. QA/QC Reporting Notes – Check appropriate reporting level and indicate any applicable limits to be met as well as any additional State

certifications required (i.e. samples for disposal out of State from where they were collected). Pertinent remarks about the sample or sample

condition may be noted.14. REPORT DELIVERY Indicate EDD format if one is needed in addition to PDF of laboratory report and list email address(es) of recipients.15. Condition Upon Receipt For laboratory use only.16. SIGNATURES FOR CUSTODY PURPOSES Use as many lines as necessary to show transfer and receipt of samples.a. Relinquished by Signature of person who relinquishes samples.b. Received by Signature of person who accepts samples.c. Date/Time List date and time of sample transfer.d. Temp Sample temperature will be recorded by laboratory personnel upon laboratory receipt of samples.

Rev. Jan 2014

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Document Title: Comprehensive Quality Assurance Manual

Eurofins Document Reference: Not Applicable

Revision: May, 2017 Effective Date: 5/01/17

COMPANY CONFIDENTIAL

Comprehensive Quality Assurance Manual

APPENDIX E

Section 6 Attachments

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C

Eurofins Spectrum Analytical Comprehensive Quality Assurance Manual

Appendix E Rev 3/27/17

Table 6.1A BFB Key Ions and Abundance Criteria

524, 624, 8260 and Direct Injection

Mass Ion Abundance Criteria

50 15.0 - 40.0% of the base peak

75 30.0 - 60.0% of the base peak

95 base peak, 100% relative abundance

96 5.0 - 8.0% of the base peak

173 less than 2.0% of mass 174

174 Greater than 50.0% of the base peak

175 5.0 - 8.0% of mass 174

176 > 95.0%, but < 101.0% of mass 174

177 5.0 - 8.0% of mass 176

Uncon

trolle

d % of masof ma

r than 50.0%than 50.0%

0 - 8.0% of m8.0% of

> 95.0%, b> 95.0%,

5.0 - 5.0 -

Copypeak k

tive abundance tive abundanc

ase peak se peak

174

Eurofins Spectrum Analytical Comprehensive Quality Assurance Manual

Appendix E Rev 3/27/17

Table 6.1B DFTPP Key Ions and Ion Abundance Criteria

GCMS SVOC’s 525.2, 625, SW846 8270

Mass Ion Abundance Criteria

51 30.0 – 60.0% of mass 198

68 less than 2.0% of mass 69

70 less than 2.0 % of mass 69

127 40.0 - 60.0 % of mass 198

197 less than 1.0 % of mass 198

198 base peak, 100% relative abundance

199 5.0 - 8.0 % of mass 198

275 10.0 - 30.0 % of mass 198

365 greater than 1.00 % of mass 198

441 Present, but less than mass 443

442 greater than 40.0 % of mass 198

443 17.0 – 23.0 % of mass 442

Notes:All ion abundances must be normalized to m/z 95, the nominal base peak, even though the ion abundance of m/z 174 may be up to 120% that of m/z 95.

f mf m

.0 % of mas% of ma

peak, 100% reak, 100%

.0 - 8.0 % of- 8.0 % o

10.0 - 3010.0 -

greagre

44242

44344U

Copy

9

mass 69 ass 6

s 198 s 198

Eur

ofin

s S

pect

rum

Ana

lyti

cal

Com

preh

ensi

ve Q

uali

ty A

ssur

ance

Man

ual

App

endi

x E

R

ev 3

/27/

17

Tab

le 6

.2

Cal

ibra

tion

Pro

ced

ure

s fo

r A

nal

ytic

al E

qu

ipm

ent

GC

Lab

orat

ory

Met

hod

Min

imum

#

of

Sta

ndar

dsfo

r In

itia

l C

alib

rati

on

Cal

ibra

tion

Fre

quen

cy

and

Con

cent

rati

onR

ange

Acc

epta

nce

Cri

teri

aC

CC

Fre

quen

cy

and

Con

cent

rati

onR

ange

Acc

epta

nce

Cri

teri

aC

orre

ctiv

eA

ctio

n

VP

H5

whe

n C

CC

fa

ils;

CR

= 1

-200

ppb

25%

RS

D o

r “r

” 0

.99

for

all t

arge

ts a

nd c

hain

s.

ICV

+20

% f

or a

ll a

naly

tes;

re

cali

brat

e if

IC

V f

ails

.

Ope

ning

and

cl

osin

g w

ith

ever

y ba

tch

of 2

0 sa

mpl

es, C

R =

50

ppb

% D

2

5% f

or a

ll ta

rget

s an

d ra

nges

wit

h th

e ex

cept

ion

of n

-non

ane

%D

30%

.

Rea

naly

ze C

CC

; if

unac

cept

able

, rep

eat

init

ial c

alib

rati

on

GR

O5

whe

n C

CC

fa

ils;

CR

= 5

0-20

00pp

b

20%

RS

D o

r “r

” 0

.99

ICV

+20

% f

or a

ll a

naly

tes;

re

cali

brat

e if

IC

V f

ails

.

Ope

ning

and

cl

osin

g w

ith

ever

y ba

tch

of 2

0 sa

mpl

es, C

R =

50

0ppb

% D

2

0%R

eana

lyze

CC

C; i

f un

acce

ptab

le, r

epea

t in

itia

l cal

ibra

tion

DR

O

5 W

hen

need

ed

CR

= 0

.2-

20m

g/kg

“r”

> 0

.99

Ope

ning

and

cl

osin

g w

ith

ever

y ba

tch

of 2

0 sa

mpl

es, C

R =

10

mg/

kg

Rec

over

y w

ithi

n 40

140%

.R

eana

lyze

CC

C, i

f un

acce

ptab

le r

epea

t in

itia

l cal

ibra

tion

Uncon

trolle

d

Acc

eA

c

SD

or

“r”

SD

or

“r”

0s

and

chai

nss

and

chai

all a

naly

tes;

l a

naly

tes

fail

s.

ls.

50p

50

coco

Ope

ning

Ope

clos

ing

wcl

osin

g w

very

ba

very

b Cop

y

ch o

fch

of

es, C

R =

, C

R =

pb

g an

d d hf

20

f20

Rec

140%

14

Eur

ofin

s S

pect

rum

Ana

lyti

cal

Com

preh

ensi

ve Q

uali

ty A

ssur

ance

Man

ual

App

endi

x E

R

ev 3

/27/

17

Tab

le 6

.2

Cal

ibra

tion

Pro

ced

ure

s fo

r A

nal

ytic

al E

qu

ipm

ent

GC

Lab

orat

ory

Met

hod

Min

imum

#

of

Sta

ndar

dsfo

r In

itia

l C

alib

rati

on

Cal

ibra

tion

Fre

quen

cy

and

Con

cent

rati

onR

ange

Acc

epta

nce

Cri

teri

aC

CC

Fre

quen

cy

and

Con

cent

rati

onR

ange

Acc

epta

nce

Cri

teri

aC

orre

ctiv

eA

ctio

n

NJ

EP

H/

MA

EP

H

5w

hen

CC

C

fail

s;

CR

= 5

-200

ppb

25%

RS

D f

or C

arbo

n C

hain

s an

d 15

% f

or a

ll

targ

ets;

or

“r”

0.9

9 fo

r al

l ta

rget

s an

d ch

ains

.

ICV

+20

% f

or a

ll a

naly

tes;

re

cali

brat

e if

IC

V h

as

>10

% o

f al

l ana

lyte

s fa

il.

Ope

ning

and

cl

osin

g w

ith

ever

y ba

tch

of 2

0 sa

mpl

es, C

R =

10

0ppb

% D

< 2

0% f

or a

ll ta

rget

s an

d <

25%

for

car

bon

chai

ns.

Rea

naly

ze C

CC

; if

unac

cept

able

, rep

eat

init

ial c

alib

rati

on

608

3w

hen

CC

C

fail

s;

CR

= 0

.02-

5ppb

Lin

eari

ty s

tand

ards

mus

t be

10%

RS

D; D

BC

dri

ft

mus

t be

2%

, DD

T a

nd

endr

in d

egra

dati

on

20%

co

mbi

ned;

% R

T d

rift

2%

for

a p

acke

d co

lum

n or

1.

5% f

or a

cap

illa

ry

colu

mn.

10%

RS

D f

or P

CB

and

P

esti

cide

s; o

r “r

” 0.

995

for

PC

B a

nd P

esti

cide

s.

ICV

+20

% f

or P

CB

and

P

esti

cide

s; r

ecal

ibra

te if

IC

V f

ails

.

10%

per

sam

ple

batc

h of

20

or 1

2 ho

ur s

hift

, w

hich

ever

is

mor

e fr

eque

nt;

CR

= 0

.5pp

b

RS

D15

%; D

BC

dri

ft

mus

t be

2%

; D e

ndri

n de

grad

atio

n 2

0% o

f %

R

T d

rift

2

% f

or a

pa

cked

col

umn

or

.5%

fo

r a

capi

llar

y co

lum

n.

CC

C %

D <

15%

for

all

co

mpo

unds

.

Sep

tum

cha

nge

and

colu

mn

mai

nten

ance

; re

anal

yze

CC

C; i

f un

acce

ptab

le, r

epea

t in

itia

l cal

ibra

tion

.

Uncon

trolle

d

Acc

eA

c

D f

or C

arbo

D f

or C

ar15

% f

or a

ll15

% f

or

0.9

9 fo

r al

l 0

.99

for

lyte

s;

lyte

s;

100

10

coco

% p

e%

pCop

y

sam

plsa

mpl

of 2

0 or

12

f20

or

1sh

ift, ft, er is

en

t;

RT

pack

epa

cfo

r a

cafo

r a

c

CC

CC

C

Eur

ofin

s S

pect

rum

Ana

lyti

cal

Com

preh

ensi

ve Q

uali

ty A

ssur

ance

Man

ual

App

endi

x E

R

ev 3

/27/

17

Tab

le 6

.2

Cal

ibra

tion

Pro

ced

ure

s fo

r A

nal

ytic

al E

qu

ipm

ent

GC

Lab

orat

ory

Met

hod

Min

imum

#

of

Sta

ndar

dsfo

r In

itia

l C

alib

rati

on

Cal

ibra

tion

Fre

quen

cy

and

Con

cent

rati

onR

ange

Acc

epta

nce

Cri

teri

aC

CC

Fre

quen

cy

and

Con

cent

rati

onR

ange

Acc

epta

nce

Cri

teri

aC

orre

ctiv

eA

ctio

n

8081

/808

25

whe

n C

CC

fa

ils;

8081

CR

=5-

500p

pb

8082

CR

0.0

2-5p

pb

Lin

erit

y st

anda

rds

mus

t be

10%

RS

D; D

BC

dri

ft

mus

t be

2%; D

DT

and

E

ndri

n de

grad

atio

n 30

%co

mbi

ned;

% R

T d

rift

2%

for

a pa

cked

col

umn

or

1.5%

for

a c

apil

lary

co

lum

n.

20%

RS

D f

or P

CB

and

P

esti

cide

s; o

r “r

” 0.

995

for

PC

B a

nd

0.99

for

P

esti

cide

s.

ICV

+20

% f

or P

CB

and

P

esti

cide

s; r

ecal

ibra

te if

IC

V f

ails

.

5% p

er s

ampl

e ba

tch

of 2

0 or

12

hour

shi

ft,

whi

chev

er is

m

ore

freq

uent

; C

R =

0.5

ppb

DB

C d

rift

mus

t be

2%;

DD

T a

nd e

ndri

n de

grad

atio

n20

%co

mbi

ned;

% R

T d

rift

2%

for

a p

acke

d co

lum

n or

1.5%

for

cap

illa

ry

colu

mn.

CC

C %

D <

15%

for

all

co

mpo

unds

.

Rea

naly

ze s

tand

ard;

if

unac

cept

able

, rep

eat

init

ial c

alib

rati

on.

Unco

Acc

eA

c cococont

rolle

d

tand

ards

mu

tand

ards

D

BC

dri

ft

DB

C d

rif

DD

T a

nd

DD

T a

nd

nn30

%30

%ftt

2%2%ww m

orm C

R =

0C

R

co

Copy

Eur

ofin

s S

pect

rum

Ana

lyti

cal

Com

preh

ensi

ve Q

uali

ty A

ssur

ance

Man

ual

App

endi

x E

R

ev 3

/27/

17

Tab

le 6

.2

Cal

ibra

tion

Pro

ced

ure

s fo

r A

nal

ytic

al E

qu

ipm

ent

GC

Lab

orat

ory

Met

hod

Min

imum

#

of

Sta

ndar

dsfo

r In

itia

l C

alib

rati

on

Cal

ibra

tion

Fre

quen

cy

and

Con

cent

rati

onR

ange

Acc

epta

nce

Cri

teri

aC

CC

Fre

quen

cy

and

Con

cent

rati

onR

ange

Acc

epta

nce

Cri

teri

aC

orre

ctiv

eA

ctio

n

8151

5w

hen

CC

C

fail

s;

CR

= .0

1-5p

pb

20%

RS

D f

or a

ll a

naly

tes

or “

r”

0.99

;1.

5% R

T

drif

t fro

m in

itia

l sta

ndar

d.

ICV

+20

% f

or a

ll a

naly

tes;

re

cali

brat

e if

IC

V f

ails

.

10%

per

sam

ple

batc

h of

20

or 1

2 ho

ur s

hift

, w

hich

ever

is

mor

e fr

eque

nt;

CR

= 0

.1pp

b; 1

5 pp

b fo

r M

AD

EP

M

CP

CA

M

CC

C %

D <

15%

for

all

co

mpo

unds

. DB

C d

rift

m

ust b

e 2%

; DD

T a

nd

endr

in d

egra

dati

on

20%

com

bine

d; %

RT

dri

ft

2% f

or a

pac

ked

colu

mn

or1.

5% f

or c

apil

lary

co

lum

n

Sep

tum

cha

nge

and

colu

mn

mai

nten

ance

; re

run

init

ial c

alib

rati

on

if r

eana

lysi

s fa

ils

Uncon

trolle

d

Acc

eA

c

D f

or a

ll a

naD

for

all

1.

5% R

T

1.5%

Ral

sta

ndar

d.

l sta

ndar

anal

ytes

; al

ytes

ss

ww mor

m CR

= 0

CR

pp

b fo

r M

ppb

for

MM

CP

CA

MC

P C

A

coco

d ddCop

yCCC

Eur

ofin

s S

pect

rum

Ana

lyti

cal

Com

preh

ensi

ve Q

uali

ty A

ssur

ance

Man

ual

App

endi

x E

R

ev 3

/27/

17

Tab

le 6

.3

Cal

ibra

tion

Pro

ced

ure

s fo

r A

nal

ytic

al E

qu

ipm

ent

Inor

gan

ic L

abor

ator

y

Met

hod

Min

imum

# o

f S

tand

ards

for

In

itia

lC

alib

rati

on

Cal

ibra

tion

Fre

quen

cy a

nd

Con

cent

rati

onR

ange

Met

hod

of

Cur

ve G

ener

atio

n A

ccep

tanc

eC

rite

ria

CC

CF

requ

ency

and

C

once

ntra

tion

Ran

ge

Acc

epta

nce

Cri

teri

aC

orre

ctiv

eA

ctio

n

ICP

Met

als

5D

aily

/ w

ith

each

us

e; 0

- 5

ppm

or

0-50

0 de

pend

ing

on th

e an

alyt

e

Fiv

e po

int c

urve

w

ith

auto

mat

ic

inst

rum

ent s

oftw

are

calc

ulat

ion

Cor

rela

tion

Coe

ffic

ient

>0.

998

ICV

+/-

5%

of

true

val

ue b

y E

PA

200

.7**

. IC

V +

/- 1

0% o

f tr

ue v

alue

by

EP

A 6

010

Eve

ry 1

0 sa

mpl

es o

r le

ss

+/-

10%

R

eana

lyze

d C

CV

; if

una

ccep

tabl

e,

repe

at in

itia

l ca

libr

atio

n

ICP

-MS

Met

als

6D

aily

/ w

ith

each

us

e; 0

- 1

00 p

pbL

inea

r re

gres

sion

; au

tom

atic

in

stru

men

t sof

twar

e ca

lcul

atio

n

Cor

rela

tion

Coe

ffic

ient

>0.

998

ICV

+/-

10%

of

true

val

ue

Eve

ry 1

0 sa

mpl

es o

r le

ss

+/-

10%

R

eana

lyze

d C

CV

; if

una

ccep

tabl

e,

repe

at in

itia

l ca

libr

atio

n

Mer

cury

6D

aily

/ w

ith

each

us

e; 0

- 1

0 pp

b L

inea

r re

gres

sion

; au

tom

atic

in

stru

men

t sof

twar

e ca

lcul

atio

n

Cor

rela

tion

Coe

ffic

ient

>0.

995

ICV

+/-

5%

of

true

val

ue*

Eve

ry 1

0 sa

mpl

es o

r le

ss

+/-

10%

* R

eana

lyze

d C

CV

; if

una

ccep

tabl

e,

repe

at in

itia

l ca

libr

atio

n

Uncon

trolle

d

onon and

and

Cur

veC

ur e po

int c

urve

e po

int c

uut

omat

ic

utom

atic

nt

sof

twar

e nt

sof

twar

II true

tr

uE

PA

2E

PA

ICV

+/-

1IC

V +

/tr

ue v

alue

bru

e va

lue

A 6

0A

60

coco

Copy

atio

nonie

nttsa

mp E

Eur

ofin

s S

pect

rum

Ana

lyti

cal

Com

preh

ensi

ve Q

uali

ty A

ssur

ance

Man

ual

App

endi

x E

R

ev 3

/27/

17

Tab

le 6

.3

Cal

ibra

tion

Pro

ced

ure

s fo

r A

nal

ytic

al E

qu

ipm

ent

Inor

gan

ic L

abor

ator

y

Met

hod

Min

imum

# o

f S

tand

ards

for

In

itia

lC

alib

rati

on

Cal

ibra

tion

Fre

quen

cy a

nd

Con

cent

rati

onR

ange

Met

hod

of

Cur

ve G

ener

atio

n A

ccep

tanc

eC

rite

ria

CC

CF

requ

ency

and

C

once

ntra

tion

Ran

ge

Acc

epta

nce

Cri

teri

aC

orre

ctiv

eA

ctio

n

Cya

nide

6D

aily

/ w

ith

each

us

e; 0

- 3

00 p

pb

Lin

ear

regr

essi

on

Cor

rela

tion

coef

fici

ent

>0.

997

ICV

+/-

10%

of

true

val

ue

10%

or

ever

y 2

hour

s,

whi

chev

er is

m

ore

freq

uent

, 0.

50 p

pm

+ 1

0%

Tru

e V

alue

R

ecal

ibra

te a

s ne

eded

. R

erun

all

sa

mpl

es n

ot

prec

eded

and

/or

foll

owed

by

acce

ptab

leIC

V/I

CB

,C

CV

/CC

B

Flu

orid

eE

PA

300

.0

4W

ith

each

use

0.

10 -

5.0

ppm

L

inea

r R

egre

ssio

n C

orre

lati

onco

effi

cien

t>

0.99

7

10%

or

ever

y 2

hour

s,

whi

chev

er is

m

ore

freq

uent

, 0.

40 -

2.5

0 pp

m

+ 1

0%

Tru

e V

alue

R

erun

all

sam

ples

no

t pre

cede

d an

d/or

fo

llow

ed b

y ac

cept

able

ICV

/IC

B,

CC

V/C

CB

Sul

fate

sE

PA

300

.0

6W

ith

each

use

1.

0 -

50 p

pm

Lin

ear

regr

essi

on;

each

cho

rd is

ca

lcul

ated

&

repo

rted

sep

arat

ely

Cor

rela

tion

coef

fici

ent

>0.

997

10%

or

ever

y 2

hour

s,

whi

chev

er is

m

ore

freq

uent

, 4.

0 -

25 p

pm

+ 1

0%

Tru

e V

alue

R

erun

all

sam

ples

no

t pre

cede

d an

d/or

fo

llow

ed b

y ac

cept

able

ICV

/IC

B,

CC

V/C

CB

.

Uncon

trolle

d

and

an ononC

uC

Lin

ear

regr

esL

inea

r re

g

oo

nnnncnc

dorre

lati

rrel

atfi

Copy

ntnt7

w mor

em 0.

40 -

20.

40pp

m

ppm

10%

o10

%

Eur

ofin

s S

pect

rum

Ana

lyti

cal

Com

preh

ensi

ve Q

uali

ty A

ssur

ance

Man

ual

App

endi

x E

R

ev 3

/27/

17

Tab

le 6

.3

Cal

ibra

tion

Pro

ced

ure

s fo

r A

nal

ytic

al E

qu

ipm

ent

Inor

gan

ic L

abor

ator

y

Met

hod

Min

imum

# o

f S

tand

ards

for

In

itia

lC

alib

rati

on

Cal

ibra

tion

Fre

quen

cy a

nd

Con

cent

rati

onR

ange

Met

hod

of

Cur

ve G

ener

atio

n A

ccep

tanc

eC

rite

ria

CC

CF

requ

ency

and

C

once

ntra

tion

Ran

ge

Acc

epta

nce

Cri

teri

aC

orre

ctiv

eA

ctio

n

Chl

orid

esE

PA

300

.0

6W

hen

need

ed

0.10

- 5

.0 p

pm

Lin

ear

regr

essi

on;

each

cho

rd is

ca

lcul

ated

&

repo

rted

sep

arat

ely

Tot

al c

urve

co

rrel

atio

nco

effi

cien

t>

0.99

5

10%

or

ever

y 2

hour

s,

whi

chev

er is

m

ore

freq

uent

, 10

ppm

+ 1

0% T

rue

Val

ueR

erun

all

sam

ples

no

t pre

cede

d an

d/or

fo

llow

ed b

y ac

cept

able

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/IC

B, C

CV

, C

CB

Not

es:

CB

= C

onti

nuin

g C

alib

rati

on B

lank

C

CV

= C

onti

nuin

g C

alib

rati

on V

erif

icat

ion

ICV

= I

niti

al C

alib

rati

on V

erif

icat

ion

ICB

= I

niti

al C

alib

rati

on B

lank

pp

m =

Par

ts P

er M

illi

on

ppb

= P

arts

Per

Bil

lion

*Mer

cury

IC

V/C

CV

: At l

east

one

of

thes

e sa

mpl

es, p

refe

rabl

y th

e IC

V, m

ust f

all w

ithi

n 5%

of

its

true

val

ue, w

hile

the

othe

r on

e m

ay b

e w

ithi

n 10

% o

f tr

ue v

alue

. **

Aqu

eous

200

.7 I

CV

mus

t be

+/-

5%

of

true

val

ue f

or in

itia

l QC

cri

teri

a; s

ubse

quen

t IC

V m

ust b

e +

/- 1

0% o

f tr

ue v

alue

.

Uncon

trolle

and

an ononC

uC

Lin

ear

regr

esL

inea

r re

gh

chor

d is

h

chor

d is

ated

&

ted

&

sepa

rate

ly

sepa

rate

ly

nnnncnc

olled

olle

Copy

whi

le th

e ot

her

e th

e ot

heue

val

ueue

va

Eur

ofin

s S

pect

rum

Ana

lyti

cal

Com

preh

ensi

ve Q

uali

ty A

ssur

ance

Man

ual

App

endi

x E

R

ev 3

/27/

17

Tab

le 6

.4

Cal

ibra

tion

Pro

ced

ure

s fo

r A

nal

ytic

al E

qu

ipm

ent

Org

anic

Ch

arac

teri

zati

on L

abor

ator

y

Met

hod

Min

imum

#

of

Sta

ndar

dsfo

r In

itia

l C

alib

rati

on

Cal

ibra

tion

Fre

quen

cy a

nd

Con

cent

rati

onR

ange

Acc

epta

nce

Cri

teri

a

CC

CF

requ

ency

and

Con

cent

rati

on

Acc

epta

nce

Cri

teri

aC

orre

ctiv

eA

ctio

n

Oil

&

Gre

ase/

TP

H

1664

6W

hen

need

ed,

scal

es a

re

chec

ked

dail

y w

ith

2mg

to

1000

mg

Cla

ss

“S”

wei

ghts

.

±10%

at 2

mg

and

±0.5

% a

t 10

00m

g

Che

ckba

lanc

eca

libr

atio

npr

ior

to a

nd

afte

rw

eigh

ing

sam

ple

batc

h.

±10%

at 2

mg

and

±0.5

% a

t 100

0mg

Re-

cali

brat

e sc

ale;

rew

eigh

sam

ple

batc

h.

TP

H 8

100M

/8

015D

5W

hen

need

ed

+ 2

% d

iffe

renc

e fo

r 2

inje

ctio

ns;

corr

elat

ion

coef

fici

ent

0.99

5

one

ever

y 20

an

alys

esC

R =

10p

pm

QC

rec

over

y 40

-14

0%R

erun

cal

ibra

tion

. I

f co

ntin

uing

ca

libr

atio

n fa

ils,

rea

naly

ze s

ampl

es

run

befo

re c

onti

nuin

g ca

libr

atio

n fa

iled

Tot

alO

rgan

icC

arbo

n

2D

aily

/wit

h ea

ch

use

0 -

100

ppm

Cor

rela

tion

coef

fici

ent m

ust

be >

0.0

997

one

ever

y 10

an

alys

es C

R =

5

ppm

+ 1

5%

Rer

un C

alib

rati

on. I

f co

ntin

uing

ca

libr

atio

n fa

ils,

rea

naly

ze s

ampl

es

run

befo

re c

onti

nuin

g ca

libr

atio

n fa

iled

.

Uncon

trolle

d

ndd

Acc

epA

c Cri

teri

Cri

t

2mg

2mg t

Ch

C bala

ncba ca

libr

atio

cali

brat

iopr

ior

to a

nd

prio

r to

an

ererhi

ngng batc

h.

tch.

onon

Copy

QC

rec

ovQ

C r

ec14

0%14

0%

Document Title: Comprehensive Quality Assurance Manual

Eurofins Document Reference: Not Applicable

Revision: May, 2017 Effective Date: 5/01/17

COMPANY CONFIDENTIAL

Comprehensive Quality Assurance Manual

APPENDIX F

Section 7 Attachments

Uncon

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Eurofins Spectrum Analytical, Comprehensive Quality Assurance Manual

Appendix F Revised 9/29/15

SOP REQUEST FOR CREATION OR MODIFICATION

Date:

SOP:

Requested by:

APPROVED or DENIED

New revision number:

Expected Date of Completion:

Please provide a brief description for why SOP needs to be created or modified:

Laboratory Director Date

QA Manager Date

Uncncon

trolle

d dleolltrontr

onconc

Copyed or modior moypyopCoC

Document Title: Comprehensive Quality Assurance Manual

Eurofins Document Reference: Not Applicable

Revision: May, 2017 Effective Date: 5/01/17

COMPANY CONFIDENTIAL

Comprehensive Quality Assurance Manual

APPENDIX G

Section 11 Attachments

Uncon

trolle

d Cop

ynts s

Eurofins Spectrum Analytical, Comprehensive Quality Assurance Manual

Appendix G

Table 11.1 Reagent Storage

Reagent Container Storage Area

Hexane Stored in 4-liter amber glass bottles Vented, flammable storage cabinets 1,3

Methylene Chloride Stored in 4-liter amber glass bottles Vented, flammable storage cabinets 1,3

Pentane Stored in 4-liter amber glass bottles Vented, flammable storage cabinets 1

Ethyl Acetate Stored in 4-liter amber glass bottles Vented, flammable storage cabinets 1

Acetonitrile Stored in 1-liter amber glass bottles Vented, flammable storage cabinets 1

1 Sooctone Stored in 4-liter amber glass bottles Vented, flammable storage cabinets 1

Ethyl Ether Stored in 4-liter TinVented, flammable storage cabinets 1

Nitric Acid Stored in 2.5 Liter glass bottles Vented, cabinets designed for acid storage 1

Hydrochloric Acid Stored in 2.5 Liter glass bottles Vented cabinet designed for acid storage 1

Sulfuric Acid Stored in 2.5 Liter glass bottles Vented cabinet designed for acid storage 1,3

Acetone Stored in 4 Liter Plastic bottles Vented cabinet designed for volatile storage 1

Acetone Stored in 4 Liter Amber bottles Vented, flammable storage cabinets 1

Potassium Permanganate Stored in a 500 gm amber glass bottle Cabinet 1 *

Hydrogen Peroxide Stored in a 500 ml plastic bottle Cabinet 1 *

Stannous Chloride Stored in a 500 gm plastic bottle Cabinet 1 *

Potassium Persulfate Stored in a 500 gm Plastic bottle Cabinet 1 *

Magnesium Perchlorate Stored in a 500 gm amber glass bottle and a 2.5 Kg Plastic bottle

Cabinet 1 *

Sodium Bisulfate Stored in a 500 gm Plastic bottle Cabinet 1 *

glass boss b

TinTind

.5 Liter glassLiter glasolle

red in 2.5 Litin 2.5 Litr

UnnStored inStored inonUnUnSSUnnUU

CopyVeVstorastopyttles ttlesVpypy

les l Co

Eurofins Spectrum Analytical, Comprehensive Quality Assurance Manual

Appendix G

Table 11.1 Reagent Storage

Reagent Container Storage Area Sodium Chloride Stored in a 5 gm Plastic bottle Cabinet 1 *

Hydroxylamine Sulfate Stored in a 500 gm Plastic bottle Cabinet 1 *

Methanol Stored in a 500 ml amber glass bottle Vented, flammable storage cabinets 2

Notes: 1 Located at 11 Almgren Dr Lab 2 Located at 830 Silver St Lab

3 Bulk storage is in a designated area in original shipping containers and packaging. * Reactive and oxidizing reagents are stored separately from corrosive reagents

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116

Hea

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116

Hea

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413-

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116

Hea

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116

Hea

lth &

co

uC

OU

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116

Hea

lth &

co

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Hea

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ork

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116

Hea

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lmgr

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AG

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Tom

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116

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AG

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116

Hea

lth &

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OU

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RA

lmgr

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am,M

AH

and

cart

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ustr

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2413

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116

Hea

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co

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lmgr

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and

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116

Hea

lth &

co

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OU

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RA

lmgr

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and

cart

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2413

01N

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yes

116

Hea

lth &

co

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OU

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RA

lmgr

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am,M

AH

and

cart

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2413

01N

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116

Hea

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co

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OU

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RA

lmgr

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and

cart

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2413

01N

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116

Hea

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co

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RA

lmgr

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and

cart

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2413

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116

Hea

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RA

lmgr

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and

cart

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2413

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116

Hea

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lmgr

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and

cart

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2413

01N

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116

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lmgr

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am,M

AIc

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achi

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Alm

gren

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Ice

Mac

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Sto

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Bin

Man

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2053

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yes

116

Hea

lth &

co

uC

OU

RIE

RA

lmgr

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gaw

am,M

AP

acka

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cale

Cou

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Pel

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IER

Alm

gren

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yes

125

Gar

age

GA

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GE

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Hyd

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rep

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Leem

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lmgr

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Pro

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315-

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AG

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AS

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Sto

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ifier

450

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Gar

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GA

RA

GE

Alm

gren

Aga

wam

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Vac

uum

Pum

pS

tora

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feiff

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2333

880

no50

1M

OE

Offi

ceG

AR

AG

EA

lmgr

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gaw

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AA

utod

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tor

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oblo

ck 2

Env

ironm

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l Exp

ress

SC

862

0605

DU

R08

41

yes

120

Met

als

Pre

p IN

OR

GA

lmgr

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gaw

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AA

utos

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AS

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1620

A56

01

yes

121

Met

als

Inst

ruIN

OR

GA

lmgr

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gaw

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AA

utos

ampl

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AP

CE

TA

CA

SX

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0312

148A

520

1ye

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1M

etal

s In

stru

INO

RG

Alm

gren

Aga

wam

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Aut

osam

pler

(Spa

re)

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TA

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ecno

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1ye

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etal

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gren

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pler

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0213

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1ye

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etal

s In

stru

INO

RG

Alm

gren

Aga

wam

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Aut

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pler

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RC

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Y4

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4035

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etal

s In

stru

INO

RG

Alm

gren

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Aut

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pler

ICP

MS

2P

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lmer

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702

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etal

s In

stru

INO

RG

Alm

gren

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Bal

ance

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le #

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3492

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120

Met

als

Pre

p IN

OR

GA

lmgr

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AB

alan

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1ye

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etal

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M Io

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2490

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s P

rep

INO

RG

Alm

gren

Aga

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Chi

ller

ICP

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2P

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ence

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2224

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1111

254

1ye

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etal

s In

stru

INO

RG

Alm

gren

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wam

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Chi

ller

ICA

P1

The

rmo

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rmoF

lex9

0012

7134

0114

0523

1ye

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1M

etal

s In

stru

INO

RG

Alm

gren

Aga

wam

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chill

erIC

AP

2T

herm

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herm

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1271

3570

1140

528

1ye

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1M

etal

s In

str u

INO

RG

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gren

Aga

wam

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chill

erIC

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4T

herm

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herm

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R08

2540

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yes

121

Met

als

Inst

ruIN

OR

GA

lmgr

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gaw

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AF

ume

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Ham

ilton

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yes

124

Met

als

Pre

p IN

OR

GA

lmgr

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gaw

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ume

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No

mar

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yes

120

Met

als

Pre

p IN

OR

GA

lmgr

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AH

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late

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4713

510

7303

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891

yes

124

Met

als

Pre

p IN

OR

GA

lmgr

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gaw

am,M

AH

ot P

late

Hot

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teT

herm

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P47

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1030

3028

4577

1ye

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etal

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rep

INO

RG

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gren

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Hot

bloc

kH

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Env

ironm

enta

l Exp

ress

SC

154

3826

CE

C18

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yes

124

Met

als

Pre

p IN

OR

GA

lmgr

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gaw

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AH

otbl

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1685

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etal

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rep

INO

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gren

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wam

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Hot

bloc

kH

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Env

ironm

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l Exp

ress

SC

154

3826

CE

C18

221

yes

120

Met

als

Pre

p IN

OR

GA

lmgr

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gaw

am,M

AIC

AP

ICA

PT

herm

o S

cien

tific

6500

2007

2108

1ye

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etal

s In

stru

INO

RG

Alm

gren

Aga

wam

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Icap

ICA

P2

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rmo

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entif

ic65

0020

1127

051

yes

121

Met

als

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ruIN

OR

GA

lmgr

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gaw

am,M

AIc

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AP

4T

herm

o S

cien

tific

6500

IC5D

2011

4909

1ye

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etal

s In

stru

INO

RG

Alm

gren

Aga

wam

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ICP

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ICP

MS

2P

erki

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lmer

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yes

121

Met

als

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ruIN

OR

GA

lmgr

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AM

ars

Xpr

ess

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row

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Mar

s M

icro

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101

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120

Met

als

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p IN

OR

GA

lmgr

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AM

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omat

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ME

RC

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gren

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utom

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sH

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121

Met

als

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ruIN

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GA

lmgr

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AO

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Var

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e T

rans

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Pow

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yes

124

Met

als

Pre

p IN

OR

GA

lmgr

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gaw

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AR

efrig

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DM

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6571

51

yes

130

Hal

lway

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gren

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TC

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GA

lmgr

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Rot

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ator

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Env

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5511

1256

61

yes

124

Met

als

room

INO

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gren

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Hot

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Env

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l Exp

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151

6791

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124

Met

als

Pre

p IN

OR

GA

lmgr

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71

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Met

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ilton

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124

Met

als

Pre

p IN

OR

GA

lmgr

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AA

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lave

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8000

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MIC

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Alm

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2-01

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120

Met

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Met

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S

C15

167

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EC

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481

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124

Met

als

MIC

RO

BIO

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gren

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gren

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MIC

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Alm

gren

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Hot

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4091

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yes

124

Met

als

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BIO

Alm

gren

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wam

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Hot

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te/S

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NA

NA

1ye

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MIC

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gren

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Labs

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1030

3028

4577

1030

3028

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1819

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181

3CE

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1685

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182282

Copye1

yes

1ye

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yes

1ye

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yes

1ye

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01

yes

1ye

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11

yes

11

yes

124

es1

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yes

130

0no

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Met

als

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124

M12

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s P

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als

120

Met

als

Met

al12

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116

1693

701

yes

117

Mic

robi

olog

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cuba

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yes

117

Mic

robi

olog

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lmgr

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am,M

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cuba

tor

Mic

Sun

beam

1693

701

yes

117

Mic

robi

olog

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lmgr

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cuba

tor

Incu

bato

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1ye

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biol

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MIC

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BIO

Alm

gren

Aga

wam

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Incu

bato

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ater

bat

h#2

Pre

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on60

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biol

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MIC

RO

BIO

Alm

gren

Aga

wam

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Mic

rosc

ope

Mic

Oly

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MIC

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BIO

Alm

gren

Aga

wam

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Mic

rosc

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w/c

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2N

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yes

117

Mic

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MIC

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Alm

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Ref

riger

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agic

Che

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02M

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MIC

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BIO

Alm

gren

Aga

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Ultr

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let L

amp

Mic

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PU

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yes

117

Mic

robi

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Filt

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120

Met

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MIC

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BIO

Alm

gren

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p (2

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117

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117

Mic

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side

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ver

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124

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ffice

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124

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71

yes

123

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yes

123

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ffice

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DA

lmgr

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le D

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3391

191

yes

124

Hal

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DA

lmgr

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AO

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tform

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kers

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axq

2000

1410

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2350

61

yes

124

R &

D O

ffice

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DA

lmgr

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kers

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axq

2000

1410

0610

0817

01

yes

124

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D O

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kers

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2000

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3253

41

yes

124

R &

D O

ffice

R&

DA

lmgr

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am,M

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zone

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erat

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4471

51

yes

124

R &

D O

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R&

DA

lmgr

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ceR

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gren

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pH /

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7319

61

yes

123

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lmgr

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AS

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yes

123

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D O

ffice

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DA

lmgr

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am,M

AS

tir p

late

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7143

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51

yes

124

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DA

lmgr

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yes

123

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ffice

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lmgr

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AS

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late

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yes

126

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DA

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171

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126

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LOG

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gren

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1152

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yes

115

LOG

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gren

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LOG

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PLE

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gren

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EM

P G

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617

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103

LOG

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PLE

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gren

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IR T

herm

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115

LOG

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yes

103

LOG

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gren

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roco

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ther

mom

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yes

103

LOG

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2000

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2000

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122

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122

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122

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122

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130

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142 N

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51

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51

yes

11

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103

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115

LOG

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olog

ies

GC

PA

L16

0947

1ye

s13

0S

VO

C G

C R

SV

OC

Alm

gren

Aga

wam

,MA

Aut

osam

pler

HP

S-1

4ALE

AP

Tec

hnol

ogie

sG

C P

AL

1609

301

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AA

utos

ampl

erH

PS

-17

Leap

Tec

hnol

ogie

sG

C P

AL

1613

991

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AA

utos

ampl

erH

PS

-18

Leap

Tec

hnol

ogie

sG

CP

AL

1603

691

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AA

utos

ampl

erH

PS

-19

Leap

Tec

hnol

ogie

sG

CP

AL

1603

121

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AA

utos

ampl

erH

PS

-2LE

AP

Tec

hnol

ogie

sG

C P

AL

1609

561

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AA

utos

ampl

erH

PS

-3LE

AP

Tec

hnol

ogie

sG

C P

AL

1604

281

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AA

utos

ampl

erH

PS

-7LE

AP

Tec

hnol

ogie

sG

C P

AL

1608

051

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AA

utos

ampl

er T

ray

HP

S-1

5A

gile

ntG

2614

AC

N62

9404

961

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AA

utos

ampl

er T

ray

HP

S-1

6A

gile

ntG

2614

AC

N70

2426

011

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AA

utos

ampl

er T

ray

HP

S-4

Agi

lent

G26

14A

CN

7104

3246

1ye

s13

0S

VO

C G

C R

SV

OC

Alm

gren

Aga

wam

,MA

Aut

osam

pler

Tra

yH

PS

-5A

gile

ntG

2614

AC

N71

9439

371

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AA

utos

ampl

er T

ray

HP

S-6

Agi

lent

G26

14A

CN

7204

4008

1ye

s13

0S

VO

C G

C R

SV

OC

Alm

gren

Aga

wam

,MA

Aut

osam

pler

Tra

y 76

93H

PS

8A

gile

ntG

4519

AC

N11

5000

191

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AB

alan

ceS

cale

#11

Den

ver

Inst

rum

ents

DI

2255

0872

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Bal

ance

Sca

le #

3M

ettle

rA

E20

0-S

K65

275

0no

122

Sto

rage

SV

OC

Alm

gren

Aga

wam

,MA

Bal

ance

Sca

le #

1AM

ettle

r T

oled

oX

S10

411

2842

0705

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Bal

ance

Sca

le #

16In

telli

gent

Wei

ghin

g T

ech.

PA

200

0912

0111

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Cen

trifu

geC

entr

ifuge

Fis

her

226

2603

0no

122

Sto

rage

SV

OC

Alm

gren

Aga

wam

,MA

Cen

trifu

geC

entr

ifuge

Fis

her

228

FS

1766

10

no12

2S

VO

C P

rep

SV

OC

Alm

gren

Aga

wam

,MA

Chi

ller

Chi

ller

Pol

y S

cien

ceN

0691

883

G57

680

1ye

s12

2S

VO

C P

rep

SV

OC

Alm

gren

Aga

wam

,MA

Fum

e H

ood

Pre

p 31

fishe

r-H

amilt

onS

afea

ire II

2677

901

yes

122

Pre

p R

oom

SS

VO

CA

lmgr

enA

gaw

am,M

AF

ume

Hoo

dP

rep

10La

bcon

co60

830-

00/D

NA

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Fum

e H

ood

Pre

p 18

Labc

onco

NA

NA

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Fum

e H

ood

Pre

p 19

Labc

onco

6083

0-00

/D26

7789

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Fum

e H

ood

Pre

p 25

Labc

onco

NA

NA

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Fum

e H

ood

Pre

p 27

Labc

onco

No

Vis

ible

Num

bers

N/A

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Fum

e H

ood

Pre

p16

Labc

onco

6083

0-00

/D26

7790

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Fum

e H

ood

Pre

p 20

NA

NA

NA

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Gas

Chr

omat

ogra

phS

tora

geP

erki

n E

lmer

N61

161

0N 4

0902

040

no13

0S

VO

C G

C R

SV

OC

Alm

gren

Aga

wam

,MA

Gas

Chr

omat

ogra

ph (

Dua

l EC

D)

HP

S-1

1A

gile

nt68

90 s

erie

sU

S00

0397

131

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AG

as C

hrom

atog

raph

(D

ual E

CD

)H

PS

-12

Agi

lent

6890

ser

ies

CN

1044

5021

1ye

s13

0S

VO

C G

C R

SV

OC

Alm

gren

Aga

wam

,MA

Gas

Chr

omat

ogra

ph (

Dua

l EC

D)

HP

S-1

4AA

gile

nt68

90N

CN

1060

2096

1ye

s13

0S

VO

C G

C R

SV

OC

Alm

gren

Aga

wam

,MA

Gas

Chr

omat

ogra

ph (

Dua

l EC

D)

HP

S-1

7A

gile

nt68

90N

US

1072

1002

1ye

s13

0S

VO

C G

C R

SV

OC

Alm

gren

Aga

wam

,MA

Gas

Chr

omat

ogra

ph (

Dua

l EC

D)

HP

S-1

9A

gile

nt78

90N

CN

1072

1099

1ye

s13

0S

VO

C G

C R

SV

OC

Alm

gren

Aga

wam

,MA

Gas

Chr

omat

ogra

ph (

Dua

l FID

)H

PS

-18

Agi

lent

6890

NC

N10

6020

351

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AG

as C

hrom

atog

raph

(F

ID)

HP

S-1

5A

gile

nt68

90N

US

1072

1003

1ye

s13

0S

VO

C G

C R

SV

OC

Alm

gren

Aga

wam

,MA

Gas

Chr

omat

ogra

ph (

FID

)H

PS

-16

Agi

lent

6890

NU

S10

7210

071

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AG

as C

hrom

atog

raph

(F

ID/M

S)

HP

S-2

Agi

lent

6890

NC

N10

4190

461

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AG

as C

hrom

atog

raph

(F

ID/M

S)

HP

S-3

Agi

lent

6890

NU

S10

1510

721

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AG

as C

hrom

atog

raph

(F

ID/M

S)

HP

S-5

Agi

lent

6890

NC

N10

6030

831

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AG

as C

hrom

atog

raph

(F

ID/M

S)

HP

S-7

Agi

lent

6890

US

0000

1599

1ye

s13

0S

VO

C G

C R

SV

OC

Alm

gren

Aga

wam

,MA

Gas

Chr

omat

ogra

ph (

MS

)H

PS

-4A

gile

nt68

90 s

erie

sU

S00

0410

571

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AG

as C

hrom

atog

raph

(M

S)

HP

S-6

Agi

lent

7890

NC

N10

7130

191

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AG

as C

hrom

atog

raph

(M

S)

HP

S8

Agi

lent

7890

AC

N12

0511

121

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AH

igh

Thr

ough

put 2

4-S

ampl

e R

otor

Rot

or (

hold

s ve

sses

l)M

ilest

one

Pro

-24

578

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Hig

h T

hrou

ghpu

t 24-

Sam

ple

Rot

orR

otor

(ho

lds

vess

esl)

Mile

ston

eP

ro-2

458

91

yes

122

Pre

p R

oom

SS

VO

CA

lmgr

enA

gaw

am,M

AH

olde

rP

rep

Gla

s-C

ol09

9A V

H 2

0005

3935

371

yes

122

Pre

p R

oom

SS

VO

CA

lmgr

enA

gaw

am,M

AH

olde

rP

rep

Gla

s-C

ol09

9A V

H 2

0005

3915

141

yes

122

Pre

p R

oom

SS

VO

CA

lmgr

enA

gaw

am,M

AH

olde

rP

rep

Gla

s-C

ol09

9A V

H 2

0005

4749

421

yes

122

Pre

p R

oom

SS

VO

CA

lmgr

enA

gaw

am,M

AH

olde

rP

rep

Gla

s-C

ol09

9A V

H 2

0005

4749

431

yes

122

Pre

p R

oom

SS

VO

CA

lmgr

enA

gaw

am,M

AH

olde

rP

rep

Gla

s-C

ol09

9A V

H 2

0005

4749

441

yes

122

Pre

p R

oom

SS

VO

CA

lmgr

enA

gaw

am,M

AH

olde

rP

rep

Gla

s-C

ol09

9A V

H 2

0005

3935

291

yes

122

Pre

p R

oom

SS

VO

CA

lmgr

enA

gaw

am,M

AH

olde

rP

rep

Gla

s-C

ol09

9A V

H 2

0005

4749

461

yes

122

Pre

p R

oom

SS

VO

CA

lmgr

enA

gaw

am,M

AH

olde

rP

rep

Gla

s-C

ol09

9A V

H 2

0005

4749

491

yes

122

Pre

p R

oom

SS

VO

CA

lmgr

enA

gaw

am,M

AH

olde

rP

rep

Gla

s-co

l3-

D40

1647

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Hol

der

Pre

pG

las-

col

3-D

4016

481

yes

122

Pre

p R

oom

SS

VO

CA

lmgr

enA

gaw

am,M

AH

olde

rP

rep

Gla

s-co

l3-

D40

1649

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Hol

der

Pre

pG

las-

col

3-D

4016

501

yes

122

Pre

p R

oom

SS

VO

CA

lmgr

enA

gaw

am,M

AH

ot B

lock

Hot

blo

ck 4

Env

ironm

enta

l Exp

ress

SC

100

145C

EC

0186

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Hot

Pla

teS

oxhl

etC

ole

Par

mer

Vel

a03

401-

4091

7050

2492

081

yes

122

Pre

p R

oom

SS

VO

CA

lmgr

enA

gaw

am,M

AH

ot P

late

Sox

hlet

Col

e P

arm

er V

ela

0340

1-40

9170

5024

803

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Hot

Pla

teS

VO

CC

ole

Par

mer

Vel

a03

401-

4091

7047

6859

1ye

s13

0S

VO

C G

C R

SV

OC

Alm

gren

Aga

wam

,MA

Hot

Pla

teS

VO

CC

ole

Par

mer

Vel

a03

401-

4091

7050

2477

981

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AH

ot P

late

SV

OC

Col

e P

arm

er V

ela

0340

1-40

9170

5024

7802

1ye

s13

0S

VO

C G

C R

SV

OC

Alm

gren

Aga

wam

,MA

Hot

Pla

teS

VO

CC

ole

Par

mer

Vel

a03

401-

4091

7050

2478

031

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AH

ot P

late

SV

OC

Col

e P

arm

er V

ela

0340

1-40

9170

5204

9207

1ye

s13

0S

VO

C G

C R

SV

OC

Alm

gren

Aga

wam

,MA

Hot

Pla

teS

VO

CC

ole

Par

mer

Vel

a03

401-

4091

7050

2492

101

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AH

ot P

late

Sox

hlet

Fis

her

NA

1000

170

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Hot

Pla

teS

oxhl

etF

ishe

r11

-100

-100

SH

1886

0703

0321

11

yes

122

Pre

p R

oom

SS

VO

CA

lmgr

enA

gaw

am,M

AUnc

ontro

lled

nstr

umen

tsst

rum

ents

Aol

edo

oled

oX

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eigh

ing

Tec

h.P

A20

0ei

ghin

g T

ech.

P 226

22 228

228

N06

9188

3N

0691

88S

afea

ire II

Saf

eaire

60

830-

00/D

6083

0-00

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AN

A 830-

00/D

0-0

e N

umbe

rsum

be

U CN

1C

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6010

6U

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7210

US

1072

10C

N10

7210

99C

N10

721

CN

1060

2035

N10

6U

S10

7210

03U

S10

7210

03U

S10

7210

07U

S10

7210

07N

1041

9046

N10

4190

4601

5107

201

5107

203

08383

59999 7

Copye1

yes

1ye

s1

yes

1ye

s1

yes

1ye

s12

1ye

s12

21

yes op

y

1ye

s12

21

yes

11

yes

122

es1

1ye

s12

2P

yes

122

yes

122

Pre

p12

2es

122

Pre

p R

o12

2P

122

Pre

p R

oom

122

P12

2P

rep

Roo

22P

rep

R12

2P

rep

RP

rep y

122

Pre

22 2P

Hot

Pla

teS

VO

CF

ishe

r11

-498

-7S

561-

0097

11

yes

130

SV

OC

GC

RS

VO

CA

lmgr

enA

gaw

am,M

AH

ot P

late

/Stir

rer

Soh

let

Fis

her

11-1

00-1

00S

H18

8607

3032

151

yes

122

Pre

p R

oom

SS

VO

CA

lmgr

enA

gaw

am,M

AH

ot P

late

/Stir

rer

Sox

hlet

Fis

her

11-1

00-1

00S

H18

8607

0303

193

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Hot

Pla

te/S

tirre

rS

oxhl

etF

ishe

r11

-100

-100

SH

1886

0703

0194

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Hot

Pla

te/S

tirre

rS

oxhl

etF

ishe

r11

-100

-100

SH

1886

0703

0320

61

yes

122

Pre

p R

oom

SS

VO

CA

lmgr

enA

gaw

am,M

AH

ot P

late

/Stir

rer

Sox

hlet

Fis

her

11-1

00-1

00S

H18

8607

0303

215

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Hot

Pla

te/S

tirre

rS

oxhl

etF

ishe

r11

-100

0-10

0SH

1886

0703

0319

71

yes

122

Pre

p R

oom

SS

VO

CA

lmgr

enA

gaw

am,M

AH

ot P

late

/Stir

rer

Sox

hlet

Fis

her

11-4

98-7

556

1009

711

yes

122

Pre

p R

oom

SS

VO

CA

lmgr

enA

gaw

am,M

AH

ot P

late

/Stir

rer

Sox

hlet

Fis

her

11-1

00-1

00S

H18

8409

0804

190

1ye

s12

2P

rep

Roo

m S

SV

OC

Alm

gren

Aga

wam

,MA

Hot

Pla

te/S

tirre

rS

oxhl

etF

ishe

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her

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yes

126

Wet

che

m A

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lmgr

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(6 ft

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No

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yes

126

Wet

che

m A

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rer

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51

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7298

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431

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126

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che

m A

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(D

ione

x)IC

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hem

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126

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che

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126

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126

Wet

che

m in

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71

yes

126

Wet

che

m s

oWE

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MA

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126

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061

yes

126

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che

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126

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111

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126

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126

Wet

che

m in

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301

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130

Hal

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130

Hal

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126

Wet

che

m L

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126

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126

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126

Wet

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01

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126

Wet

che

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21

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126

Wet

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m m

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126

Wet

che

m m

WE

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her

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126

Wet

che

m m

WE

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#5F

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126

Wet

che

m m

WE

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#6F

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netic

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ning

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4409

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yes

126

Wet

che

m m

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yes

126

Wet

che

m L

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1333

501

yes

126

Wet

che

m m

WE

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HE

MA

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351

yes

126

Wet

che

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WE

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Boa

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111

yes

126

Wet

che

m in

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126

Wet

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126

Wet

che

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WE

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126

Wet

che

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Aut

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Com

pute

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HP

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7700

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107

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Com

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Offi

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Son

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Offi

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Com

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Com

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Com

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Offi

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Offi

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Offi

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Com

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Offi

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Met

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Met

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gren

Aga

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VA

703b

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6158

01

yes

107

Met

als

Pre

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AC

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met

alsp

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HP

DC

7800

US

DT

MX

L807

05T

91

yes

107

Met

als

Pre

pM

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lmgr

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ALC

Dm

etal

spre

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iew

Son

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Met

als

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gren

Aga

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Com

pute

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ro S

FF

MX

L214

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yes

107

Offi

ceM

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ALC

Dtc

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Fla

tron

W24

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81

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107

Offi

ceM

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AP

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300

JPB

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yes

107

Met

als

Pre

pM

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am,M

AP

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203

5388

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Met

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Alm

gren

Aga

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Prin

ter

HP

Lase

rJet

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NB

CC

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D1

yes

107

Offi

ceM

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lmgr

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am,M

AC

ompu

ter

valg

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HP

DC

5000

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6010

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Mic

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Son

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CN

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8378

781

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107

Mic

roM

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Alm

gren

Aga

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Com

pute

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1H

PD

C50

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1805

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Son

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71

yes

107

NY

Syr

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Hub

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7033

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yes

107

NY

Syr

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use,

NY

LCD

NE

CA

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72V

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515N

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107

NY

Syr

acus

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use,

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Prin

ter

HP

Lase

rJet

410

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SJN

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klap

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P40

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FF

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1KK

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QA

Silv

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Dkl

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on E

2411

209N

DM

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K59

51

yes

107

Offi

ceQ

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,MA

Sca

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DR

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Silv

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HP

4000

Pro

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F2U

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107

Offi

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LCD

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gen

LGF

latr

on W

2442

PA

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105N

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QA

Silv

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CN

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QA

Silv

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AC

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HP

DC

7800

US

DT

MX

L807

05T

M1

yes

107

Offi

ceR

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Alm

gren

Aga

wam

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LCD

mla

mbe

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VA

703b

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91

yes

107

Offi

ceR

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Alm

gren

Aga

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Prin

ter

HP

Lase

rJet

220

0JP

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C79

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HP

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Pro

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Sam

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gren

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LCD

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G07

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Sam

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Aga

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Sca

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Can

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Sam

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Com

pute

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FF

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Sam

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Sam

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Can

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Sam

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Com

pute

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Sam

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gren

Aga

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VA

703b

Q85

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6161

61

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107

Offi

ceS

ampl

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AS

cann

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Can

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0761

71

yes

107

Offi

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am,M

AC

ompu

ter

kwilk

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nH

P40

00 P

ro S

FF

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1280

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71

yes

107

Offi

ceS

ampl

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Dkw

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Sam

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Can

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DE

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KC

1553

31

yes

107

Offi

ceS

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am,M

AC

ompu

ter

sam

ple

HP

DC

7800

US

DT

MX

L807

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107

Offi

ceS

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Son

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Can

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Sam

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Com

pute

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les

HP

DC

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MX

L751

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Sam

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Son

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107

Offi

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Can

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Sam

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Prin

ter

HP

Lase

rJet

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5554

91

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107

Offi

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107

Offi

ceS

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AC

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ter

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HP

4000

Pro

SF

FM

XL2

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yes

107

Offi

ceS

VO

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Dds

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Son

icV

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AG

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51

yes

107

Offi

ceS

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Dds

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Fla

tron

E24

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KD

4V89

31

yes

107

Offi

ceS

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ter

hps1

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2411

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107

SV

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gren

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Com

pute

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HP

4000

Pro

SF

F2U

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21

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107

SV

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Alm

gren

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CN

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107

SV

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Alm

gren

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E24

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yes

107

SV

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OC

Alm

gren

Aga

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Com

pute

rhp

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HP

DC

5700

MX

M74

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R1

yes

107

SV

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Alm

gren

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LCD

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107

SV

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SV

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Alm

gren

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LCD

hps1

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tron

E24

111

yes

107

SV

OC

SV

OC

Alm

gren

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Com

pute

rhp

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HP

4000

Pro

SF

FM

XL2

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Phi

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Lase

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71

yes

11

yes

107

es1

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107

yes

107

Offi

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107

Offi

ce10

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Offi

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Offi

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Offi

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Offi

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Offi

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Com

pute

rhp

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HP

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SF

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107

SV

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Alm

gren

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LCD

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ell

1907

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D-A

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yes

107

SV

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SV

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Alm

gren

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Com

pute

rhp

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Del

lO

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lex

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11

yes

107

SV

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SV

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Alm

gren

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LCD

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iew

Son

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Opt

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Dhp

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VA

1903

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QJ0

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71

yes

107

SV

OC

SV

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Alm

gren

Aga

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Com

pute

rhp

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Del

lO

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FD

11

yes

107

SV

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SV

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Alm

gren

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Son

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VA

703b

Q85

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6186

81

yes

107

SV

OC

SV

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Alm

gren

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Com

pute

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PD

C57

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XM

7440

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Son

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91

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107

SV

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Alm

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Fla

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E24

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107

SV

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Alm

gren

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Prin

ter

hps4

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Lase

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220

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1801

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107

SV

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Alm

gren

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Com

pute

rhp

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107

SV

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Alm

gren

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Del

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11

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107

SV

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Alm

gren

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LCD

hps6

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VA

1903

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0723

5440

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107

SV

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Alm

gren

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Com

pute

rhp

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P40

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FF

MX

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107

SV

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Alm

gren

Aga

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Com

pute

rhp

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P62

00 P

ro S

FF

MX

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11

yes

107

SV

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SV

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Alm

gren

Aga

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LCD

hps8

Vie

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onic

VA

2223

wm

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DS

TC

1206

2058

11

yes

107

SV

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SV

OC

Alm

gren

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Com

pute

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P40

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ro S

FF

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Alm

gren

Aga

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LCD

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LGF

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on W

2442

PA

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110N

DG

LB08

951

yes

107

Offi

ceS

VO

CA

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iew

Son

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1340

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Alm

gren

Aga

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Com

pute

rsv

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HP

DC

5100

MX

L625

0MK

M1

yes

107

Offi

ceS

VO

CA

lmgr

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am,M

ALC

Dsv

oc1

Vie

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onic

VA

2223

wm

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TC

1201

2036

91

yes

107

Offi

ceS

VO

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Dsv

oc1

LGF

latr

on E

2411

202N

DU

N2P

558

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ffice

SV

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Alm

gren

Aga

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Com

pute

rsv

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HP

DC

5700

MX

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Document Title: Comprehensive Quality Assurance Manual

Eurofins Document Reference: Not Applicable

Revision: May, 2017 Effective Date: 5/01/17

COMPANY CONFIDENTIAL

Comprehensive Quality Assurance Manual

APPENDIX H

Section 12 Attachments

Uncon

trolle

d Cop

yments ments

Eurofins Spectrum Analytical Comprehensive Quality Assurance Manual

Appendix H Rev 3/27/17

Table 12.1 Concentration Levels for QC Samples

Sample Type

PurposeConcentration

LevelMethod

Reference

Matrix Spike (MS) Accuracy Mid Level EPA 500 & 600 Series;EPA SW-846 Methods

Matrix Spike Duplicate (MSD) Precision/Accuracy Mid Level

EPA 500 & 600 Series; EPA SW-846 Methods

Blank Spike Accuracy Mid Level EPA 500 & 600 Series; EPA SW-846 Methods

EPA TO Methods

Duplicate Precision Mid Level EPA SW-846 Methods

EPA TO Methods

QC Checks AccuracyLow/Mid/HighLevel

EPA 500 & 600 Series: EPA SW-846 Methods

EPA TO Methods

Notes:Low Level = Concentrations from the minimum detection limit to a level five times the MDL Mid Level = Mean level between the minimum detection level and the upper end of the linear

rangeHigh Level = Concentrations at the upper end of the linear range

Low/Mid/How/Mid/HLevelLevel

ons from the mns from the mvel between thebetween th

ncentrations at ntrations at

lle

onon

CopyEPA 500 500

EPA SW-8PA SW

EPA TO MEPA TO M

vel l EPA EPA

EP

Eurofins Spectrum Analytical Comprehensive Quality Assurance Manual

Appendix H Rev 3/27/17

Table 12.2 QC Frequency Information: Method Blanks

LaboratoryDepartment

Method Frequency

Air APH Minimum 5%

Air TO-15 Minimum 5%

Air TO-18 Minimum 5%

Volatile 524.2/624 Minimum 5%

Volatile 8260 Minimum 5%

Volatile VPH MA DEP Method/GRO

Minimum 5%

Semi-volatile 504.1/625 Minimum 5%

Semi-volatile 608 (PCBs/Pesticides) Minimum 5%

Semi-volatile 8270 Minimum 5%

Semi-volatile NJ EPH/MA DEP EPH/ Method/DRO/8100M/8015D/TPH1664B/TPH 8100 by GC

Minimum 5%

Semi-volatile 8151, 8081, 8082, Herbicides/Pesticides/PCB

Minimum 5%

OrganicCharacterization

Oil & Grease - EPA 1664 Minimum 5%

OrganicCharacterization

SM5310B Total Organic Carbon (TOC) Minimum 10%

Inorganic200.7, 6010 ICP, 200.8, 6020 ICP-MS Metals

Minimum 5%

Inorganic245.1, 7470, 7471 Mercury by CV-AAS (A)

Minimum 5%

Inorganic 300.0 Sulfate Minimum 10%

Inorganic 300.0 Chloride Minimum 10%

Inorganic 300.0 Fluoride Minimum 10%

Inorganic 300.0 Nitrate/Nitrite Minimum 10%

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) MiniMini

A DEP EPH/ EP EPH/ DRO/RO/

M/8015D/TPH015D/TPH64B/TPH 810B/TPH 81

8151, 8081151, 8081HerbicidHerbici

OO

Copym 5% %

mum 5% mum 5%

mum 5%mum

Eurofins Spectrum Analytical Comprehensive Quality Assurance Manual

Appendix H Rev 3/27/17

Table 12.2 QC Frequency Information: Method Blanks

LaboratoryDepartment

Method Frequency

Inorganic 9012B/335.4 Cyanide Minimum 10%

Note that QC frequency may vary depending on matrix and/or specific federal or state agency requirements (as noted in QC box on Chain of Custody).

Uncon

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d Cop

y

Eurofins Spectrum Analytical Comprehensive Quality Assurance Manual

Appendix H Rev 3/27/17

Table 12.3 QC Frequency Information: Fortified Blank Spikes also known as Laboratory

Control Samples (BS/BSD)* and Standard Reference Materials (SRM)**

LaboratoryDepartment

Method Frequency

Air APH Minimum 5% (BS)

Air TO-15 Minimum 5% (BS)

Air TO-18 Minimum 5% (BS)

Volatile GC/MS 524.2Minimum 5% (BS)

Volatile GC/MS 624/8260Minimum 5% (BS/BSD pair)

Volatile GC VPH MA DEP Method/GRO

Minimum 5% (BS/BSD pair)

Semi-volatile GC/MS 625 Minimum 5% (BS)

Semi-volatile GC/MS 504.1 Minimum 10% (BS)

Semi-volatile GC 608 (PCBs, Pesticides)

Minimum 5% (BS/BSD pair)

Semi-volatile GC/MS 8270 Minimum 5% (BS/BSD pair)

Semi-volatile GC NJ EPH/MA DEP EPH Method

Minimum 5% (BS/BSD pair)

Semi-volatile GC DRO/8100M /8015D/ TPH 8100 by GC

Minimum 5% (BS)

Semi-volatile GC 8081/8082(Pesticides/PCBs)

Minimum 5% (BS/BSD pair)

Semi-volatile GC 8151A (Herbicides) Minimum 5% (BS/BSD pair)

OrganicCharacterization

TPH by 1664B, Oil & Grease EPA 1664B

Minimum 5% (BS)

OrganicCharacterization

SM5310B Total Organic Carbon

Minimum 5% (BS)

Uncon

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MiniMin

608 (PCBs, 8 (PCBsPesticidesPesticides

MS 8270S 8270

Copy(BS) S)

m 5% (BS) m 5% (BS)

5% (B

Eurofins Spectrum Analytical Comprehensive Quality Assurance Manual

Appendix H Rev 3/27/17

Table 12.3 QC Frequency Information: Fortified Blank Spikes also known as Laboratory

Control Samples (BS/BSD)* and Standard Reference Materials (SRM)**

LaboratoryDepartment

Method Frequency

Inorganic 200.7 ICP, 200.8 ICP-MS Metals

Minimum 5% (Aqueous BS) (Soil SRM)

Inorganic6010 ICP/6020 ICP-MS Metals

Minimum 5% (Aqueous BS/BSD) (Soil SRM)

Inorganic245.1, 7470, 7471 Mercury by CV-AAS (A)

Minimum 5% (Aqueous BS) (Soil SRM)

Inorganic 300.0 Sulfate Minimum 10% (BS/SRM)

Inorganic 300.0 Chloride Minimum 10% (BS/SRM)

Inorganic 300.0 Fluoride Minimum 10% (BS/SRM)

Inorganic 300.0 Nitrate/Nitrite Minimum 10% (BS/SRM)

Inorganic 9012B/335.4 CyanideMinimum 10% (Aqueous BS) (Soil SRM)

Notes: * BS sample = deionized water fortified with target compounds and surrogate standards. **SRM sample = deionized water fortified with SRM solution. Note that QC frequencies may vary depending on matrix and/or specific federal or state agency requirements (as noted in QC box on Chain of Custody). QCs are the same for both soil and aqueous samples, except where noted.

UnUnUnconwater fortified wr fortified

ater fortified wfortified way vary dependry depen

n QC box on Chn QC box on Che noted. oted.

ontro

lled

inimnim

MinimumMinimum

MinimMini

/Nitrite Mitrite

/335.4 Cyani5.4 Cyan

on

Un

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5% (Aqueous B(Aqueous B

m 10% (Bm 10%

Eurofins Spectrum Analytical Comprehensive Quality Assurance Manual

Appendix H Rev 3/27/17

Table 12.4 QC Frequency Information:

Matrix Spikes (MS), Matrix Spike Duplicates (MSD)* and/or Post Spikes (PS)**

LaboratoryDepartment

Method Frequency

Air APH N/A

Air TO-15 N/A

Air TO-18 N/A

Volatile 524.2/624/8260 Minimum 5% (MS/MSD pair)

Volatile VPH MADEP Method/GRO

Minimum 5% (MS)

Semi-volatile 504.1/625.2/8270Minimum 5% (MS/MSD pair)

Semi-volatile 608 (PCBs, Pesticides) Minimum 10% (MS)***

OrganicCharacterization NJ EPH/MADEP EPH

Minimum 5% (MS)

EPH only if client requested, then (MS/MSD pair)

Semi-volatile 8151A/8081/8082(Herbicides/Pesticides/PCB)

Minimum 5% (MS)***

OrganicCharacterization

Oil & Grease EPA 1664B Minimum 5% (MS/MSD pair)***

OrganicCharacterization

SM5310B Total Organic Carbon (TOC)

Minimum 10%

Inorganic6010 ICP, 6020 ICP-MS Metals

Minimum 5% (MS/MSD/PS)

Inorganic200.7 ICP, 200.8 ICP-MS Metals

Minimum 10% (MS/PS)

Inorganic7470, 7471 Mercuryby CV-AAS (A)

Minimum 5% (MS/MSD/PS)

Inorganic245.1 Mercuryby CV-AAS (A)

Minimum 10% (MS/ PS)

Inorganic 300.0 Sulfate Minimum 10% (MS/MSD)

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esticides) cides)

H/MADEP EMADEP

8151A/808151A/80(Herbici(HerbiPCB)PCB

Copy

imum 5% (MS/Mum 5% (MS/M

Minimum 5%Minimum

mu

Eurofins Spectrum Analytical Comprehensive Quality Assurance Manual

Appendix H Rev 3/27/17

Table 12.4 QC Frequency Information:

Matrix Spikes (MS), Matrix Spike Duplicates (MSD)* and/or Post Spikes (PS)**

LaboratoryDepartment

Method Frequency

Inorganic 300.0 Chloride Minimum 10% (MS/MSD)

Inorganic 300.0 Fluoride Minimum 10% (MS/MSD)

Inorganic 300.0 Nitrate/Nitrite Minimum 10% (MS/MSD)

Inorganic 9012B/335.4 CyanideMinimum 10% (MS/MSD/PS)

Notes:

* MS/MSD sample – sample spiked with target compounds used for Precision/Accuracy and to determine if there is matrix interference.

** PS sample – sample spiked with target compounds after digestion/extraction to determine if there is matrix interference due to the digestion/extraction procedure.

***Submittal of sufficient sample volume/weight is required to run QC sample spikes and duplicates.

Note that QC frequencies may vary depending on matrix and/or specific federal or state agency requirements (as noted in QC box on Chain of Custody).

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.

red to run QC d to run QC

trix and/or specrix and/or sptody).y)

olollCop

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opy

(

10% % SD/PS)/PS)

opy

Eurofins Spectrum Analytical Comprehensive Quality Assurance Manual

Appendix H Rev 3/27/17

Table 12.5 QC Frequency Information: Duplicates*

LaboratoryDepartment

Method Frequency

Air APH Minimum 5%

Air TO-15 Minimum 5%

Air TO-18 Minimum 5%

Semi-volatile 625.2/8270 Minimum 5%

Semi-volatile 608 (PCBs, Pesticides) Minimum 5%

Semi-volatile 8081/8082(Pesticides/PCBs)

Minimum 5%

Semi-volatile 8151A (Herbicides) Minimum 5%

Inorganic200.7, 6010 ICP, 200.8, 6020 ICP-MS Metals

Minimum 5%

Inorganic245.1, 7470, 7471 Mercury by CV-AAS (A)

Minimum 5%

Inorganic 300.0 Chloride Minimum 5%

Inorganic 300.0 Sulfate Minimum 5%

Inorganic 300.0 Nitrate/Nitrite Minimum 5%

Inorganic 300.0 Fluoride Minimum 5%

OrganicCharacterization

NJ EPH/MADEP VPH /GRO/DRO/8100M/8015D/TPH 8100 by GC

Minimum 5%

(Soils: only if sufficient sample is submitted)

Notes:

Note that QC frequency may vary depending on matrix and/or specific federal or state agency requirements (as noted in QC box on Chain of Custody).

*Submittal of sufficient sample volume/weight is required to run duplicates and QC sample spikes.

Uncon

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200.8, 200.8, Metals als

MM

70, 7471 0, 7471 y by CV-AAby CV-A

300.0 Chlori0 Chlor

300.0 Su300.0

300300

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um 5% 5%

nimum 5% imum 5

m

Document Title: Comprehensive Quality Assurance Manual

Eurofins Document Reference: Not Applicable

Revision: May, 2017 Effective Date: 5/01/17

COMPANY CONFIDENTIAL

Comprehensive Quality Assurance Manual

APPENDIX I

Section 13 Attachments

Uncon

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d Cop

ynts s

Eurofins Spectrum Analytical Comprehensive Quality Assurance Manual

Appendix I

Revised 3-27-17

Table 13.1 QC Sample Acceptance Criteria and Corrective Action: Method Blanks

Department Method Acceptance Criteria Corrective Action

Air APH All surrogates within control limits (CL); TCL< Detection Limits (DL)

Reanalyze and/or flag non-conforming data, as appropriate or narrate as appropriate.

Air TO-15 All surrogates within CLs; TCL<DL Reanalyze and/or flag non-conforming data, as appropriate or narrate as appropriate.

Air TO-18 All surrogates within CLs; TCL<DL Reanalyze and/or flag non-conforming data, as appropriate or narrate as appropriate.

Volatile 524.2 All surrogates within CLs; TCL<DL

Decontaminate lines & traps. Flush trap and column. Reanalyze until blank meets criteria or narrate as appropriate.

Volatile 624 All surrogates within CLs; TCL<DL

Decontaminate lines & traps. Flush trap and column. Reanalyze until blank meets criteria or narrate as appropriate.

Volatile 8260

All surrogates within CLs; TCLs < DL except common laboratory contaminants (acetone, methylene chloride, and MEK) which must be <5X the DL.

Decontaminate lines and trap. Flush column. Reanalyze until blank meets all criteria or narrate as appropriate.

Volatile VPH/GRO All surrogates within CLs; TCL<DL

Decontaminate lines and trap. Flush column. Reanalyze until blank meets all criteria or narrate as appropriate.

Semi-volatile 504.1TCL < DL

Halt analysis until the problem is identified and corrected. Re-extract entire batch or narrate as appropriate.

Semi-volatile 608

Surrogates within Cls All TCLs <DL

Halt analysis until the problem is identified and corrected. Re-extract entire batch or narrate as appropriate.

Uncon

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l surrogates wurrogates

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Appendix I

Revised 3-27-17

Table 13.1 QC Sample Acceptance Criteria and Corrective Action: Method Blanks

Department Method Acceptance Criteria Corrective Action

Semi-volatile 625 All surrogates within CLs; TCL<DL

Halt analysis until the problem is identified and corrected. Re-extract entire batch or narrate as appropriate.

Semi-volatile 8270

All surrogates within CLs All TCLs <DL except common laboratory contaminants phthalates) which must be <5X DL.

Halt analysis until the problem is identified and corrected. Re-extract entire batch or narrate as appropriate.

Semi-volatile 8100Surrogates within CLs All TCLs <DL

Halt analysis until the problem is identified and corrected. Re-extract entire batch or narrate as appropriate.

Semi-volatile 8151A,

8081/8082

Surrogates within CLs All TCLs <DL

Halt analysis until the problem is identified and corrected. Re-extract entire batch or narrate as appropriate.

Organic Charact. TPH/EPH/

DROAll surrogates within CLs; TCL<DL

Prepare and reanalyze entire batch or narrate as appropriate.

Organic Charact. NJ EPH All surrogates within CLs; TCL<DL Prepare and reanalyze entire batch or narrate as appropriate.

OrganicCharact.

Oil & Grease < 1.0 ppm Prepare and reanalyze entire batch or narrate as appropriate.

Organic Charact. Total Organic

Carbon(TOC)

< 1.0 ppm < 50 ppm

Prepare and reanalyze samples or narrate as appropriate.

Inorganic

200.7, 6010 ICP Metals;

200.8, 6020 ICP-MSMetals

<CRDL or reporting limit* Prepare and reanalyze entire batch or narrate as appropriate.

Inorganic Mercury <CRDL or reporting limit* Prepare and reanalyze entire batch or narrate as appropriate.

Inorganic Sulfate <reporting limit Prepare and reanalyze entire batch or narrate as appropriate.

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Appendix I

Revised 3-27-17

Table 13.1 QC Sample Acceptance Criteria and Corrective Action: Method Blanks

Department Method Acceptance Criteria Corrective Action

Inorganic Bromide <reporting limit* Prepare and reanalyze entire batch or narrate as appropriate.

Inorganic Chlorides <reporting limit* Prepare and reanalyze entire batch or narrate as appropriate.

Inorganic Fluoride <CRDL or reporting limit Prepare and reanalyze entire batch or narrate as appropriate.

Inorganic Nitrate/Nitrite <reporting limit* Prepare and reanalyze batch or narrate as appropriate.

Inorganic Cyanides <CRDL or reporting limit Prepare and reanalyze entire batch or narrate as appropriate.

Notes: *If sample concentration is 10 times the concentration of the preparation blank, do not prepare samples again.

Target Compound Lists = TCLs

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Appendix I

Revised 3-27-17

Table 13.2 QC Sample Acceptance Criteria and

Corrective Action: Blank Spikes/Laboratory Control Samples (BS/BSD) and Standard Reference Materials (SRM)***

Department Method Acceptance Criteria Corrective Action

Air APH 70-130% RecoveryReanalyze and/or flag non-conforming data, as appropriate.

Air TO-15 50-150% Recovery for analytes*****,70-130% for all other TCLs.

Reanalyze and/or flag non-conforming data, as appropriate.

Air TO-18 70-130% Recovery Reanalyze and/or flag non-conforming data, as appropriate.

Volatile 524.270-130% for analytes****;80-120% for all other TCLs.

Analytes that do fall outside of acceptable limits are qualified. Samples that contain compounds outside of acceptable limits are reanalyzed with acceptable QCs.

Volatile 624

All spike recoveries must be within method set control limits (see lab for specific analyte limits). RPD 30%

Analytes that do fall outside of acceptable limits are qualified. Samples that contain compounds outside of acceptable limits are reanalyzed with acceptable QCs.

Volatile 8260*

No more than 10% target analytes outside of control limits (70-130%; difficult analytes may be 40-160%). RPD 25%

Analytes that do fall outside of acceptable limits are qualified. Samples that contain compounds outside of acceptable limits are reanalyzed with acceptable QCs.

Volatile VPH/GRO 70-130% Recovery; RPD 25%

Reanalyze entire batch.

Semi-volatile 504.1 70-130% Recovery If a second BS fails, locate and correct the source of the problem and re-extract/reanalyze.

Semi-volatile 608

All spike recoveries must be within method set control limits (see lab for specific analyte limits). RPD 20%

Analytes that do fall outside of acceptable limits are qualified. Samples that contain compounds outside of acceptable limits are reanalyzed with acceptable QCs.

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Appendix I

Revised 3-27-17

Table 13.2 QC Sample Acceptance Criteria and

Corrective Action: Blank Spikes/Laboratory Control Samples (BS/BSD) and Standard Reference Materials (SRM)***

Department Method Acceptance Criteria Corrective Action

Semi-volatile 625

All spike recoveries must be within method set control limits (see lab for specific analyte limits).

Flag non-conforming data.

Semi-volatile 8270

All spike recoveries must be within control limits (40-140% for base compounds and 30-130% for acids). RPD 20% for waters; 30% for soils.

Flag non-conforming data.

Semi-volatile 8100M 40-140% Recovery Flag non-conforming data.

Semi-volatile 8151A/8081/

8082

All spike recoveries must be within control limits (not greater than 40-140%).

Halt analysis until the problem is identified and corrected. Re-extract/reanalyze entire batch to verify system control restored.

Organic Charact. TPH/EPH/DRO

40-140% Recovery; RPD not greater than 30%

Prepare and reanalyze entire batch.

Organic Charact. NJ EPH 40-140% Recovery; RPD not greater than 25%

Prepare and reanalyze entire batch.

Organic Charact. Oil & Grease

166483-101%, RPD 11%

Correct problem, re-extract entire analytical batch and repeat the ongoing precision and recovery test.

Organic Charact. Total Organic

Carbon(TOC)

85-115% Recovery for Soils and Waters. Soil SRM within vendor limits.

Prepare and reanalyze calibration.

Inorganic200.7/6010ICP Metals + 15% true Prepare and reanalyze entire batch.

Inorganic200.8/6020

ICP-MSMetals

+ 15% true Prepare and reanalyze entire batch.

Inorganic Mercury + 15% true Prepare and reanalyze entire batch.

Inorganic Sulfate + 10% true Flag non-conforming data.

Inorganic Bromide*** + 10% true Flag non-conforming data.

+ 10% true Flag non-conforming data.

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Appendix I

Revised 3-27-17

Table 13.2 QC Sample Acceptance Criteria and

Corrective Action: Blank Spikes/Laboratory Control Samples (BS/BSD) and Standard Reference Materials (SRM)***

Department Method Acceptance Criteria Corrective Action

Inorganic Chlorides

Inorganic Fluoride + 10% true Flag non-conforming data.

Inorganic Nitrate/Nitrite + 10% true Flag non-conforming data.

Inorganic Cyanides + 10% true Prepare and reanalyze entire batch. Notes: * 8260 difficult analytes are Acetone, Bromomethane, Chloroethane, Dichlorodifluoromethane, Ethyl ether,

Hexachlorobutadiene, MEK, MIBK 1,4-Dioxane, Trichlorofluoromethane.

**The criteria listed is for the CCC, there is no difference from the Laboratory Fortified Blank or Blank Spike (BS) and the CCC as noted in the applicable method.

***QC sample acceptance criteria may vary for Department of Defense work; these limits are available upon request.

****Acetone, Acrylonitrile, MBK, MEK, MIBK, Carbon disulfide, Tetrahydrofuran, Ethyl ether, TAME, ETBE, DIPE, TBA, Ethanol.

*****Acrylonitrile, 1,4-Dioxane, 1,1,1,2-Tetrachloroethane, Isopropylbenzene, Naphthalene, sec-Butylbenzene, 4-Isopropyltoluene, n-Butylbenzene.

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Appendix I

Revised 3-27-17

Table 13.3 QC Sample Acceptance Criteria and

Corrective Action: Matrix Spikes (MS), MS/MSD Pair*

Department Method Acceptance Criteria Corrective Action

Volatile 524.2 80-120% Recovery; RPD 20% Flag non-conforming data.

Volatile 624 Method set recovery; RPD 30% Flag non-conforming data.

Volatile 826070-130% Recovery; 20% RPD Waters; 30% RPD Soils

Flag non-conforming data.

Volatile VPH/GRO 70-130% Recovery; RPD 30% Flag non-conforming data.

Semi-volatile 504.1 65-135% Recovery Flag non-conforming data.

Semi-volatile 608

All spike recoveries must be within method set control limits (see lab for specific analyte limits); RPD 50%

Flag non-conforming data.

Semi-volatile 625 30-140% Recovery Flag non-conforming data.

Semi-volatile 8270

40-140% recovery for base compounds and 30-130% for acids;

20% RPD Waters; 30% RPD Soils

Flag non-conforming data.

Semi-volatile 8151A/8081/

8082Recovery not greater than 30-150%; 30% RPD

Analyze CCC. If CCC is acceptable, report MS/MSD and LCS with data qualifier.

Organic Charact. TPH/EPH/

DRO40-140% recovery; <25% RPD

Analyze LCS or re-prepare and reanalyze MS/MSD

Organic Charact. NJ EPH 40-140% recovery; <50% RPD Analyze LCS or re-prepare and reanalyze MS/MSD

Organic Charact. Oil & Grease

166478-114% recovery; <18% RPD

Analyze LCS or re-prepare and reanalyze MS/MSD

Organic Charact. TOC 70-130% recovery; <30% RPD Analyze LCS or re-prepare and reanalyze MS/MSD.

Inorganic

200.7/200.8ICP/ICP-MS

Metals 70-130% recovery ** Flag non-conforming data.

Inorganic 6010/6020 75-125% recovery** Flag non-conforming data.

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Appendix I

Revised 3-27-17

Table 13.3 QC Sample Acceptance Criteria and

Corrective Action: Matrix Spikes (MS), MS/MSD Pair*

Department Method Acceptance Criteria Corrective Action

ICP/ICP-MSMetals

Inorganic Mercury 80-120% recovery** Flag non-conforming data.

Inorganic Sulfate 90-110% recovery*** Flag non-conforming data.

Inorganic Bromide 90-110% recovery*** Flag non-conforming data.

Inorganic Chlorides 90-110% recovery*** Flag non-conforming data.

Inorganic Fluoride 90-110% recovery** Flag non-conforming data.

Inorganic Nitrate/Nitrite 90-110% recovery*** Flag non-conforming data.

Inorganic Cyanide 90-110% recovery** Flag non-conforming data.

Notes:* Submittal of sufficient sample volume/weight is required to run QC sample spikes and duplicates. QC sample acceptance

criteria may vary for Department of Defense work; these limits are available upon request.

** A majority of percent recoveries (%R) must fall within the acceptance range, or representation of the batch must occur. If recovery is not within acceptance criteria, the batch quality control data is flagged with a qualifier. If the sample concentration exceeds the spike concentration the data is not flagged, even if the spike recovery is outside the acceptance range.

*** Based on a standard aqueous sample matrix or documented methods for solid preparations. Unusual practices may create interference that require different acceptance criteria. The batch quality control data will be flagged with a qualifier.

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Appendix I

Revised 3-27-17

Table 13.4 QC Sample Acceptance Criteria and

Corrective Action: Duplicates*

Department Method Acceptance Criteria** Corrective Action

Air APH 30% RPD Flag non-conforming data.

Air TO-15 30% RPD Flag non-conforming data.

Air TO-18 30% RPD Flag non-conforming data.

Volatile 524.2****30% for analytes***; 20% for all other TCLs

Flag non-conforming data.

Volatile 624**** 30% RPD Flag non-conforming data.

Volatile 8260****20% RPD Waters;

30% RPD Soils Flag non-conforming data.

Volatile VPH/GRO 50% RPD Flag non-conforming data.

Semi-volatile 608 30% RPD Flag non-conforming data.

Semi-volatile 625 30% RPD Flag non-conforming data.

Semi-volatile 827020% RPD Waters;

30% RPD Soils Flag non-conforming data.

Semi-volatile 8100 50% RPD Flag non-conforming data.

Semi-volatile 8151A/8081 30% RPD Flag non-conforming data.

Semi-volatile 8082 40% RPD Flag non-conforming data.

Organic Charact. NJ EPH/MA EPH/

DRO50% RPD Flag non-conforming data.

Organic Charact. TOC 20% RPD Flag non-conforming data.

Inorganic200.7/6010ICP metals

20% RPD Flag non-conforming data.

Inorganic200.8/6020 ICP-

MS Metals 20% RPD Flag non-conforming data.

Inorganic Mercury 20% RPD Flag non-conforming data.

Inorganic. Sulfates 20% RPD Flag non-conforming data.

Inorganic Bromide 20% RPD Flag non-conforming data.

Inorganic Chlorides 20% RPD Flag non-conforming data.

Inorganic Fluoride 20% RPD Flag non-conforming data.

Inorganic Nitrate/Nitrite 20% RPD Flag non-conforming data.

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Appendix I

Revised 3-27-17

Table 13.4 QC Sample Acceptance Criteria and

Corrective Action: Duplicates*

Department Method Acceptance Criteria** Corrective Action

Inorganic Cyanide 20% RPD Flag non-conforming data.

Notes: * Submittal of sufficient sample volume/weight is required to run QC sample spikes and duplicates.

** The majority of RPDs must meet acceptance criteria. Data will be accepted if the RPD of the batch LCS/LCSD and/or MS/MSD is within 20%. All RPD exceedances will be flagged with a qualifier.

***Acetone, Acrylonitrile, MBK, MEK, MIBK, Carbon disulfide, Tetrahydrofuran, TAME, ETBE, DIPE, TBA

****Duplicate performed upon request.

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Revision: May, 2017 Effective Date: 5/01/17

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Comprehensive Quality Assurance Manual

APPENDIX J

List of Acronyms

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Appendix J

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Appendix J Acronyms & Abbreviations

AA Atomic Absorption ACS American Chemical Society APHA American Public Health Association ASTM American Society for Testing and Materials AWWA American Water Works Association BOD Biological Oxygen Demand BRL Below Reporting Limit oC degree(s) Celsius CAR Corrective Action Report CEO Chief Executive Officer COC Chain of Custody COD Chemical Oxygen Demand conc concentration CMR Code of Massachusetts Regulations d day DEP (State of Massachusetts) Department of Environmental Protection DER (State of Florida) Department of Environmental Regulation DI De-ionized DO Dissolved Oxygen DoD Department of Defense DOH (State of New York) Department of Health ECD Electron Capture Detector ELAP Environmental Laboratory Approval Program EMSL (City of Cincinnati) Environmental Monitoring Systems Laboratory EPA Environmental Protection Agency EPH Extractable Petroleum Hydrocarbons FID Flame Ionization Detector FTIR Infrared Spectrophotometer g gram(s) GC Gas Chromatograph GC / MS Gas Chromatograph / Mass Spectrometer h hour HAAs Haloacetic Acids IC Ion Chromatograph ICP Inductively Coupled Plasma ICV Initial Calibration Verification Id Identification IS Internal Standard kg kilogram(s) L liter(s) LIMS Laboratory Information Management System LOD Limit of Detection, also known as MDL LOQ Limit of Quantitation, also known as MRL and PQL m meter(s) MCL Maximum Contaminant Level

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Appendix J

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MDL Minimum Detection Limit, also known as LOD MRL Minimum Reporting Limit, also known as PQL and LOQ mg milligram(s) min minute mL milliliter(s) mm millimeter(s) MS Mass Spectrometer MS Matrix Spike MSD Matrix Spike Duplicate um micrometer(s) NBS National Bureau of Standards NELAC National Environmental Laboratory Accreditation Conference NELAP National Environmental Laboratory Approval Program NTU Nephelometric Turbidity Units OSHA Occupational Safety and Health Administration PAHs Polynuclear Aromatic Hydrocarbons PCBs Polychlorinated Biphenyls ppb parts per billion ppm parts per million PID Photo Ionization Detector PQL Practical Quantitation Limit, also known as LOQ and MRL QA Quality Assurance QA / QC Quality Assurance / Quality Control QAO Quality Assurance Officer QC Quality Control QMP Quality Management Program R Recovery (%R: Percent Recovery) RDL Reportable Detection Limit RSD Relative Standard Deviation SD Standard Deviation SDI Sludge Density Index s second(s) SVI Sludge Volume Index SM Standard Method SOP Standard Operating Procedure SMART Self Monitoring Analytical Report Tracking SRM Standard Reference Material SW Solid Waste TCL Target Compound List THM Trihalomethane(s) TOC Total Organic Carbon TOX Total Organic Halogen TPH Total Petroleum Hydrocarbons TPH-GC Total Petroleum Hydrocarbons by Gas Chromatography TPH-IR Total Petroleum Hydrocarbons by Infrared u units USEPA United States Environmental Protection Agency VOA Volatile Organic Amber

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VOC Volatile Organic Compound VPH Volatile Petroleum Hydrocarbons WS Water Supply WP Water Pollution WPA Water Potability Analysis

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COMPANY CONFIDENTIAL

Comprehensive Quality Assurance Manual

APPENDIX K

Definitions

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Appendix K

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Appendix K Definitions

Accuracy: The closeness of agreement between an observed value and an accepted reference value. When applied to a set of observed values, accuracy will be a combination of a random component and of a common systematic error (or bias) component.

Batch: A group of samples which behave similarly with respect to the sampling or the testing procedures being employed and which are processed as a unit.

Bias: The deviation due to matrix effects of the measured value (Xs - Xu) from a known spike amount. Bias can be assessed by comparing a measured value to an accepted reference value in a sample of known concentration or by determining the recovery of a known amount of a contaminant spiked into a sample (a matrix spike). Thus, the bias (B) due to matrix effects based on a matrix spike is calculated as:

B = (Xs - Xu) - K where:

Xs = measured value for a spike sample,Xu = measured value for unspiked sample, and K = known value of the spike sample.

Using the following equation yields the percent recovery (%R).

%R = 100 (Xs - Xu) / K

Blank: see Equipment Blank, Method Blank, Trip Blank.

Calibration Check: Verification of the ratio of instrument response to analyte amounts

Carry Over: Contamination which is transmitted from one sample to another, typically from improperly or insufficiently cleaned glassware or equipment or highly contaminated samples.

Control Sample: A QC sample introduced into the process to monitor the performance of the system.

Duplicate: see Matrix Duplicate, Field Duplicate, Matrix Spike Duplicate.

Equipment A sample of analyte-free media which has been used to rinse the sampling Blank: equipment. It is collected after completion of decontamination and prior to

sampling. This blank is useful in documenting adequate decontamination of sampling equipment.

Field Duplicate: Independent samples which are collected as close as possible to the same point in space and time. They are two separate samples taken from the same source,

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Appendix K

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stored in separate containers, and analyzed independently. These duplicates are useful in documenting the precision of the sampling process.

ICV Initial calibration verification: A standard obtained or prepared from a source independent of the source of standards for the initial calibration. Its concentration should be at or near the middle of the calibration range. It is done after the initial calibration.

Laboratory Control A known matrix spiked with compound(s) representative of the target Sample (LCS): analytes. This is used to document laboratory performance also known as a

Blank Spike (BS).

Matrix: The component or substrate (e.g., waste water, drinking water) which contains the analyte of interest.

Matrix Duplicate: An intra laboratory split sample which is used to document the precision of a method in a given sample matrix.

Matrix Spike: An aliquot of a sample spiked with a known concentration of target analyte(s).The spiking occurs prior to sample preparation and analysis. A matrix spike is used to document the bias of a method in a given sample matrix.

Matrix Spike Intra laboratory split of samples spiked with identical concentrations of Duplicates: target analyte(s). The spiking occurs prior to sample preparation ana analysis.

They are used to document the precision and bias of a method in a given sample matrix.

Method Blank: An analyte-free matrix to which all reagents are added in the same volumes or proportions as used in sample processing. The method blank should be carried through the complete sample preparation and analytical procedure. The method blank is used to document contamination resulting from the analytical process.

For a method blank to be acceptable for use with the accompanying samples, the concentration in the blank of any analyte of concern should not be higher than the highest of either:

1 - The method detection limit, or

2 - Five percent of the regulatory limit for that analyte, or

3 - Five percent of the measured concentration in the sample.

Method Detection The minimum concentration of a substance that can be measured and Limit (MDL/LOD): reported with 99% confidence that the analyte concentration is greater than zero

and is determined from analysis of a sample in a given matrix type containing the analyte.

Practical Quantitation The lowest concentration that can be reliably achieved within specified

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Limit (PQL/LOQ): limits of precision and accuracy during routine laboratory operating conditions.The PQL is generally 5 to 10 times the MDL. However, it may be nominally chosen within these guidelines to simplify data reporting. For many analytes the PQL analyte concentration is selected as the lowest non-zero standard in the calibration curve. Sample PQLs are highly matrix-dependent. PQL also known as the Minimum Reporting Limit (MRL) or Limit of Quanitation (LOQ).

Precision: The agreement among a set of replicate measurements without assumption of knowledge of the true value. Precision is estimated by means of duplicate/replicate analyses. These samples should contain concentrations of analyte above the MDL, and may involve the use of matrix spikes. The Relative Percent Difference (%RPD) is used to estimate the precision between two samples. The formula for determining %RPD is:

%RPD = (value 1 - value 2) -------------------- * 100% average value

Reagent Blank: see Method Blank.

Reagent Grade: Analytical reagent (AR) grade, ACS reagent grade, and reagent grade are synonymous terms for reagents which conform to the current specifications of the Committee on Analytical Reagents of the American Chemical Society.

Reagent Water: Water that has been generated by any method which would achieve the performance specifications for ASTM Type II water.

Split Samples: Aliquot of samples taken from the same container and analyzed independently.In cases where aliquot of samples is impossible to obtain, field duplicate samples should be taken for the matrix duplicate analysis.

Standard Addition: The practice of adding a known amount of an analyte to a sample immediately prior to analysis. It is typically used to evaluate interferences.

Standard Curve: A plot of concentrations of known analyte standards versus the instrument response to the analyte. Calibration standards are prepared by successively diluting a standard solution to produce working standards which cover the range of the instrument.

Surrogate: An organic compound which is similar to the target analyte(s) in chemical composition and behavior in the analytical process, but which is not normally found in environmental samples. These compounds are spiked into all blanks, standards, and samples prior to analysis. Percent recoveries are calculated for each surrogate.

Trip Blank: A sample of analyte-free media taken from the laboratory to the sampling site and returned to the laboratory unopened. A trip blank is used to document

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Appendix K

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contamination attributable to shipping and field handling procedures. This type of blank is useful in documenting contamination of volatile organic samples.

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Comprehensive Quality Assurance Manual

APPENDIX L

Analytical Method References

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Appendix L

Analytical Method References

SW 846 Test Methods for Evaluating Solid Waste. Third edition, 1998

40 CFR 136

Guidelines Establishing Test Procedures for the Analysis of Pollutants Under the Clean Water Act

40 CFR 141 National Primary Drinking Water Regulations

40 CFR 143 National Secondary Drinking Water Regulations

40 CFR 160

Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), Good Laboratory Practice Standards

310 CMR 42.00

Massachusetts. Department of Environmental Protection. 310 CMR 42.00: Certification and Operation of Environmental Analysis Laboratories, 10/05/2007.

APHA-AWWA-WPCF

Standard Methods for the Examination of Water and Wastes

ASTM D 3328 Standard Methods for the Comparison of Waterborn Petroleum Oils by Gas Chromatography

EPA 540/G-87/003 Data Quality Objectives for Remediation Response Activities, Development Process

EPA 600/4-79-012 Quality Assurance Handbook for Analytical Quality Control in Water and Wastewater Laboratories

EPA 600/4-79-019 Handbook for Analytical Quality Control in Water and Wastewater Laboratories

EPA 600/4-79-020 Method for the Chemical Analysis of Water and Wastes

EPA 600/4-82-057 Methods for Organic Chemical Analysis of Municipal and Industrial Wastewater

EPA 600/4-85/056 Choosing Cost-Effective QA/QC (Quality Assurance/Quality Control) Programs for Chemical Analysis

EPA 600/4-88/039 Method for the Determination of Organic Compounds in Drinking Water

MADEP EPH Method for the Determination of Extractable Petroleum Hydrocarbons (EPH)

MADEP VPH Method for the Determination of Volatile Petroleum Hydrocarbons (VPH)

NELAC National Environmental Laboratory Accreditation Conference. NELAC Standard., Quality Systems, 06/05/2003 and 09/08/2009.

NJ EPH Method for the Determination of Extractable Petroleum Hydrocarbons (EPH)

DOD Department of Defense Quality Systems Manual for Environmental Laboratories, most current revision

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Eurofins Spectrum Analytical Comprehensive Quality Assurance Manual

Appendix L

Analytical Method References

QAMS 004/80 Guidelines and Specifications for Preparing Quality Assurance Program Plans, USEPA Office of Monitoring System and Quality Assurance

USACE RIM US Army Corp of Engineers, Regional Implementation Manual

US Coast Guard GC-D-52-77

Oil Spill Identification System

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