Draft PWS - Radiological Sample Analysis Services.docx

PERFORMANCE WORK STATEMENT (PWS)

Radiological Sample Analysis Services Part 1 General Information

1. General: This is a non-personal service(s) contract under which the personnel rendering the service(s) are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

1.1 Description of Services/Introduction: This is a non-personal service(s) contract to provide Radiological Sample Analysis in support of the Military operating environments and military bases to ensure the safety and security of all who work there.

1.2 Background: The Lab Sciences (LS) Directorate currently analyzes environmental and biosurveillance samples for various radiological contaminates in support of the Defense Centers for Public Health – Aberdeen (DCPH-A) mission. However, the LS does not currently have the analytical capability and/or capacity to perform all radiological analyses required including analyses from various worldwide locations and from natural or man-made disaster locations.

1.3 Scope: The Contractor shall provide non-personal services(s). The Contractor shall provide radiological analyses on environmental and biosurveillance samples and provide the results of various compounds in each sample. The data obtained under this contract shall be used to comply with Federal and State requirements. The Contractor shall perform the analyses to the standards and acceptable quality level identified in this PWS and associated contract documents.

1.4 Objectives: The objective of this contract is to:

· Provide quality sample analysis on environmental and biosurveillance samples for various radiological contaminates as identified in this PWS in accordance with the documented methodology.

· Use industry standard state-of-the-art instrumentation, technologies, and methodologies to analyze samples for any of the parameters listed in Technical Exhibit B.

· Receipt and storage of samples prior to analysis.

1.5 General Information:

1.5.1 Quality Control Plan (QCP): RESERVED

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

1.5.3 Recognized Holidays: The following provides information on recognized holidays for the purpose of the PWS. If submittal of any documentation (e.g. deliverables, submittals, etc.) deadlines fall on a holiday, the closest workday prior to the holiday will apply as the deadline for submittal.

1.5.3.1 U.S. Holidays: Work requested in this PWS is defined in Calendar Days. It is the Contractor’s decision on which days their staff will be working at their laboratory. Calendar days include U.S. federally recognized holidays. When a U.S. holiday occurs on a Saturday or a Sunday, the holiday is observed on the preceding Friday or following Monday, respectively. Those Holidays are as follows:

Juneteenth June 19th Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veteran’s Day November 11th Thanksgiving Day 4th Thursday in November Christmas Day December 25th

1.5.3.2 Host Nation Holidays: RESERVED

1.5.4 Operating Hours: The Government facility office hours, facility operating hours, and the Contractor support hour requirements often coincide, however, they may differ. Please refer to the following.

1.5.4.1 Government Facility Office Hours: The Government facility office hours are 0800 to 1600 Monday through Friday except U.S. Holidays identified in paragraph 1.5.3.1 above or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.

1.5.4.2 Government Facility Operating Hours: The Government facility operating hours are 0800 to 1600 Monday through Friday except U.S. Holidays identified in paragraph 1.5.3.1 above. The Government facility is closed during local or national emergencies, administrative closings, or similar Government directed facility closings.

1.5.4.3 Contractor Support Hours: RESERVED

1.5.4.3.1 Contractor Work Plan: RESERVED

1.5.5 Training Holidays: RESERVED

1.5.6 Place of Performance: The work to be performed under this contract will be performed at the Contractor’s or subcontractor’s Laboratory.

1.6 Security Requirements: The following information is provided on security related matters.

1.6.1 Security Program: RESERVED

1.6.2 Personnel Security Clearance Requirements: RESERVED

1.6.3 Installation Access: Access to U.S. installations, buildings and controlled areas is limited to personnel who meet security criteria and are authorized. Failure to submit required information/data and obtain required documentation or clearances will be grounds for denying access to U.S. installations, buildings and controlled areas. The Contractor shall ensure that any subcontractors used in performance of this contract complies with these requirements and that all employees, of both the Contractor and any subcontractor utilized by the Contractor, are made aware of and comply with these requirements.

1.6.3.1 Installation Pass Log: RESERVED

1.6.3.2 Individual Termination or Expiration of Employment: RESERVED

1.6.3.3 Contract Termination or Cancellation: RESERVED

1.6.3.4 Common Access Cards (CAC) and CAC Log RESERVED

1.6.4 Background Checks: RESERVED

1.6.4.1 U.S. Citizen: RESERVED

1.6.4.2 Local Nationals and Third Country Nationals RESERVED

1.6.5 Physical Security: RESERVED

1.6.6 Operations Security (OPSEC) Requirements: Contractor personnel shall adhere to facility security policies and restrictions. The Contractor shall immediately report suspicious activities to security personnel.

1.7 Key Control: RESERVED

1.8 Post Award Conference/Periodic Progress Meetings: The Contractor shall attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation (FAR) Subpart 42.5. This post award conference should occur within seven (7) calendar days of contract award. The Contracting Officer (CO), Contracting Officer’s Representative (COR), and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings the CO will apprise the Contractor of how the Government views the Contractor's performance and the Contractor shall apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the Government.

1.8.1 The Contractor shall attend, participate in, and furnish input to scheduled and unscheduled meetings, conferences, and briefings that relate to the functions and services herein as required by the Government to provide effective communication and impart necessary information. The Contract Manager or designated representative shall attend meetings as requested by the Government. Meeting attendees shall at times include Contractor managerial, supervisory, and other personnel knowledgeable of the subject matter. Meetings may start or end outside of regular duty hours.

1.9 Contracting Officer’s Representative (COR): Refer to Part 2 of this PWS for the definition of a COR. As determined by the CO, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the Contractor by the CO. The designation letter states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates, or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is not authorized to obligate the Government. If the work is not written in the contract, the COR is not authorized to request new work. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract, perform inspections necessary in connection with contract performance, maintain written and oral communications with the Contractor concerning technical aspects of the contract, issue written interpretations of technical requirements, including Government drawings, designs, specifications, monitor Contractor's performance and notifies both the CO and Contractor of any deficiencies, coordinate availability of Government property, and coordinate site entry of Contractor personnel.

1.10 Key Personnel: The following personnel are considered key personnel by the Government: Project Manager (PM), Alternate Project Manager, and Quality Control Manager. The Contractor shall provide a PM who shall be responsible for the performance of the work. The name of this person and an Alternate PM, who shall act for the Contractor when the PM is absent, along with a Curriculum Vitae (CV) for each of these individuals, shall be provided in writing to the CO during the post-award meeting (Deliverable 1). Acceptance of the CV by the CO is required before these individuals are permitted to perform any task on this contract. The PM and Alternate PM shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract. Qualifications for all key personnel are listed below:

a. Project Manager and Alternate Project Manager: The CV provided by the PM and Alternate PM must demonstrate a minimum of 5 years’ experience within the past 10, working as a PM on projects at least $500K or greater.

b. Quality Control Manager: The Quality Manager shall meet the following standards as identified in the TNI standard

· serve as the focal point for Quality Assurance/Quality Control (QA/QC) and be responsible for the oversight and/or review of QC data.

· have functions independent from laboratory operations for which they have QA oversight.

· be able to evaluate data objectively and perform assessments without outside (e.g., managerial) influence.

· arrange for or conduct internal audits as per Section 4.14 annually.

· notify laboratory management of deficiencies in the quality system; and

· monitor corrective actions.

1.11 Identification of Contractor Employees: RESERVED

1.12 RESERVED

1.13 Contractor Travel: RESERVED

1.14 Other Direct Costs (ODCs): RESERVED

1.15 Data Rights: RESERVED

1.16 Non-Disclosure Requirements: Performance under this contract may require the Contractor to access data and information proprietary to a Government agency, another Government Contractor, or of such nature that its dissemination or use other than as specified in this work statement would be adverse to the interests of the Government or others. The Contractor and Contractor personnel, shall not divulge or release data or information developed, or obtained under performance of this PWS, except to authorized Government personnel or upon written approval of the CO. The Contractor shall not use, disclose, or reproduce proprietary data, which bears a restrictive legend, other than as specified in this PWS. All documentation showing individual names or other personal information shall be controlled and protected under the provisions of the Privacy Act of 1974, Public Law 93-579, 5 United States Code (U.S.C.) Section 552a.

1.17 Protection of Government and Contract Information: Per Public Use Notice of Limitations stated by Defense imagery Management operations Center and contained at www.dimoc.mil/resources/limitations, the Contractor shall not cite any information (e.g., contract information, pictures, locations, etc.) obtained through this contract on any hard copy or digital marketing tools to include its company website.

1.18 Non-Disclosure Statements: The Contractor shall provide signed Non-Disclosure agreements to the Government no later than the kickoff meeting (Deliverable 2) prior to commencement of work under the contract. Disclosure of information by Contractor personnel may result in removal of Contractor personnel from performance under this contract.

1.19 Organizational Conflict of Interest (OCI): RESERVED

1.20 Phase In /Phase Out Period: RESERVED

1.21 Safety: RESERVED

1.21.1 Safety Laws and Regulations: RESERVED

1.22 Environmental Compliance: RESERVED

1.22.1 Environmental Compliance Plan and Program: RESERVED

1.23 Required Training: The following provides information on training requirements.

1.23.1 Anti-Terrorism (AT) Level I Training: All contractor employees, to include subcontractor employees, requiring access Army installations, facilities and controlled access areas shall complete AT Level I Awareness training within 15 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable. The Contractor shall submit certificates of completion for each affected Contractor employee and subcontractor employee, to the COR or to the CO, if a COR is not assigned, within 15 calendar days after completion of training by all employees and subcontractor personnel. AT level I Awareness training is available at the following website: http://jko.jten.mil.

The Contractor shall submit certificates of completion (Deliverable 3) for each affected Contractor employee and subcontractor employee to the COR within five (5) calendar days after completion of this training by all employees and subcontractor personnel. Contractor personnel shall complete refresher training (Deliverable 4) every twelve (12) months.

1.23.2 OPSEC Training: RESERVED

1.23.3 iWATCH Training: The contractor and all associated sub‐contractors shall brief all employees on the local iWATCH Army program (training standards provided by the requiring activity ATO). This local developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 15 calendar days of contract award and within 15 calendar days of new employees commencing performance with the results reported to the COR no later than 15 calendar days after contract award. Verification of the training shall be provided to the COR within five (5) calendar days after completion of the training (Deliverable 5). Training slides will be provided by the COR upon award. If the COR is not able to provide the slides, they can be found on the Army OneSource website: http://www.myarmyonesource.com/familyprogramsandservices/iwatchprogram/default.aspx.

1.23.4 Information Assurance (IA) Training: RESERVED

1.23.5 Personally Identifiable Information (PII): RESERVED

1.24. Invoicing: The Contractor shall submit invoices to Wide Area Workflow (WAWF) with sufficient documentation for the WAWF acceptor to review and approve the work performed.

PART 2

DEFINITIONS & ACRONYMS

2. Definitions and Acronyms

2.1 Definitions: Although not inclusive of every term used within this PWS, the following provides a list of definitions used throughout this PWS and commonly used in the acquisition field.

Contracting Officer (CO) – Means a person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

Contracting Officer's Representative (COR) – As defined in Defense Federal Acquisition Regulation Supplement (DFARS) 202.101, means an individual designated and authorized in writing by the CO to perform specific technical or administrative functions. DoD Instruction (DoDI) 5000.72, Part II Definitions states the following when defining a COR: “Defined in subpart 202.101 of Reference (f). Any individual delegated responsibilities pursuant to subpart 1.602-2 of Reference (e), regardless of local terminology, must be certified in accordance with this instruction. For example, local terminology can be COR, Contracting Officer’s technical representative, technical point of contact, technical representative, alternate COR, administrative COR, assistant COR, line item manager, task order manager, quality assurance personnel, quality assurance evaluator, or COR management.” In addition, Army Regulation 70-13, Chapter 2, paragraph 2-2g, states, in part, the following when providing other surveillance support personnel to assist the COR when needed, “…These other surveillance support personnel may serve as on-site representatives of the COR in performance of actual contract surveillance if they meet all COR requirements and have been appointed by the CO as alternate CORs.”

Contractor – Means a supplier or vendor awarded a contract to provide specific supplies or service to the Government. The term used in this contract refers to the prime.

Day – Means, unless otherwise specified, a calendar day.

Defective Service – Means a service output that does not meet the standard of performance associated with the PWS.

Deliverable – Means anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

Physical Security – Means that part of security concerned with physical measures designed to safeguard personnel; to prevent unauthorized access to equipment, installations, material, and documents; and to safeguard against espionage, sabotage, damage, and theft.

Quality Assurance (or Government contract quality assurance) - Means the various functions, including, inspection, performed by the Government to determine whether a Contractor has fulfilled the contract obligations pertaining to quality and quantity.

Quality Assurance Surveillance Plan (QASP) – Means the key Government-developed surveillance process document and is applied to Performance-Based Service Contracting (PBSC). The QASP is used for managing Contractor performance assessment by ensuring that systematic quality assurance methods validate that Contractor quality control efforts are timely, effective, and are delivering the results specified in the contract or task order. The QASP directly corresponds to the performance objectives and standards (i.e., quality, quantity, timeliness) specified in the PWS. It provides specific details on how the Government will survey, observe, test, sample, evaluate, and document Contractor performance results to determine if the Contractor has met the required standards for each objective in the PWS. The QASP, with very few if any exceptions, is an internal to Government document.

Quality Control – Means all necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

Subcontractor – Means one that enters into a contract with a prime Contractor. The Government does not have privity of contract with the subcontractor.

Work Week - Monday through Friday, unless otherwise specified.

2.2 Acronyms: Although not inclusive of every term used within this PWS, or that may be included in an acquisition, the following provides a list of acronyms commonly used in the acquisition field.

PART 3

GOVERNMENT PROPERTY (GP) AND SERVICES

3. Government Property and Services

3.1 Services: The Government will provide environmental and biosurveillance samples to the Contractor for sample analysis for radiological contamination identification purposes. The Government will also provide Outsource Documentation (also called pick-up order document) that will accompany each set of samples to identify the project name, requested turnaround time, requested priority, methods to be reported and sample identification information.

3.2 Facilities: RESERVED

3.3 Utilities: RESERVED

3.4 Equipment: RESERVED

3.5 Special Tooling and Test Equipment: RESERVED

3.6 Materials: RESERVED

3.7 Training: RESERVED

3.8 Common Access Cards (CAC): RESERVED

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. Contractor Furnished Property and Services

4.1 General: RESERVED

4.2 Secret Facility Clearance: RESERVED

4.3 Materials: RESERVED

4.4 Vehicles and Equipment: RESERVED

4.5 Background Checks): RESERVED

PART 5

SPECIFIC TASKS

5.1 Basic Services: The Contractor shall provide services for the analysis of environmental and biosurveillance samples for radiological contamination as identified in the PWS. The Contractor shall follow Chain-Of-Custody (COC) procedures as defined in the Contractor’s COC Standard Operating Procedure (SOP).

5.2 Tasks: Tasks consist of the following:

5.2.1 Receipt and Storage of Samples Prior to Analysis. The Government will provide samples for analysis to the Contractor facility. Each container contains specific parameters for which the sample must be analyzed. The Contractor is responsible for storing and handling the samples in accordance with any applicable analytical method specifications.

Samples will be provided to the Contractor either through a Contractor-provided courier, shipment from DCPH-A, or shipment directly from the field. All shipping costs are paid by the Government outside of this contract award.

5.2.1.1 Sample Pickup Protocol from the DCPH-A lab. If applicable, the Contractor’s courier shall be responsible for pickup (from DCPH-A), packaging and delivery of samples. Samples shall be picked up by the Contractor’s courier within 24 hours of notification by the DCPH-A COR or a designated representative. The courier is responsible for packaging and transporting the samples under conditions dictated in the applicable methodology. At the time of sample pickup by the Contractor, the samples and required tests will be identified by the DCPH-A COR on an Government provided Outsource Document. This document shall be signed and dated by the DCPH-A COR or designee to document the date and time of sample transfer to the contract lab. The Contractor courier shall date and sign the Outsource Document to conclude the transfer of possession of the sample(s). A Contractor representative/Project Manager shall document the transfer of possession from the courier to the contract lab facility including sample receipt temperature. The Contractor shall immediately report in writing to the COR all samples lost or broken in transit.

5.2.1.2 Sample Shipment Protocol from the DCPH-A lab. DCPH-A shall pay the shipping costs, outside of this contract, for transportation of the samples to the Contractor’s facility. The Contractor and DCPH-A shall store and/or ship samples in accordance with the preservation guidelines as noted in the applicable analytical method until samples are analyzed, and thereafter until results are approved by the COR. The Contractor shall immediately report all samples lost or broken in shipment, with as much detail as possible (to include but not limited to photographs, etcetera), to the COR within 4 hours of identification of the breakage. In addition, the sample receipt temperature must be reported to the COR, as applicable, within 24 hours of sample receipt. (DELIVERABLE 6)

5.2.1.3 Direct shipment of samples from the field to the Contractor. If holding times are of concern, there may be a necessity to ship the samples to the contract lab directly from the field following collection. The DCPH-A sample submitter will ship the samples and a corresponding field COC document to the contract lab.

When the contract lab receives the samples and corresponding field COC forms, the Contractor’s PM shall sign the COC forms documenting receipt of samples and immediately (within the same business day of receipt) forward the field COC to the COR for review, accountability and Laboratory Information Management System (LIMS) login at DCPH-A Lab. The Contractor’s PM shall also report to the COR the condition of the samples upon receipt (to include receipt temperature) in the Contractor lab. The DCPH-A COR shall use project planning information and the information on the COC form to generate an Outsource Sample Shipment Document containing all applicable information (i.e., DCPH-A lab ID, DCPH-A field ID, analyses requested, matrix, points-of-contact, etc.). The generated Outsource Document will be forwarded electronically to the contract laboratory. The Contractor shall then begin sample analysis. The contract laboratory PM shall assure that the contract laboratory analyzes the sample within holding times specified in applicable methodology. If paperwork from the COR is pending, the contract lab should obtain guidance from the COR to proceed with analysis to meet holding times.

5.2.2 Perform Sample Analysis within the stated Turnaround Time (TAT). The Government will designate samples as either “STANDARD”, “HIGH PRIORITY”, or “TOP PRIORITY”. TATs are calculated from the date of Contractor receipt of samples to the date of receipt of technically acceptable analysis results acceptance by the Government.

For each sample designation, the Contractor shall complete the sample analysis, final reporting and Electronic Data Deliverable (EDD) transmission within the following TAT timeframes:

STANDARD: 21 days from date of sample receipt.

HIGH PRIORITY: 12 days from the date of sample receipt.

TOP PRIORITY: 8 days from the date of sample receipt.

TAT is defined as the intervening time between the date of sample receipt in the Contractor’s laboratory (or Outsource Document for Direct Shipped Samples) to the date of receipt of a complete and technically acceptable data package (Final PDF copy (Deliverable 7) + EDD (Deliverable 8)) by the DCPH-A laboratory. Technical acceptability will be determined by a thorough review by qualified DCPH-A technical Subject Matter Experts and communicated to the COR for any required actions with the Contractor. Holidays and weekends are considered ‘calendar’ days.

Approximately 5% of the total samples forwarded to the Contractor per year shall be designated high priority and 5% of the total samples sent to the Contractor shall be designated top priority.

5.2.3 Provide analytical results (the complete data package) to the COR.

5.2.3.1 The Contractor shall submit the results of all analyses within the TAT timelines as defined on the Outsource Sample Shipment Document for each set of samples. The results shall be submitted electronically to the COR and include the information requested in the format outlined in the Final Reporting Requirements (Technical Exhibit C & Technical Exhibit D). The Contractor shall at least report at or below the limits identified in Technical Exhibit B.

Extensions for matrix issues and sample analysis anomalies may be negotiated with the COR on a case-by-case basis. However, these issues must be communicated to the COR when they occur, prior to the due date and when the lab believes a delay is possible, not after the data package is overdue.

5.2.3.2 Use industry standard state-of-the-art instrumentation, technologies, and methodologies to analyze samples for any of the parameters listed in Technical Exhibit B. Any special analyses or additional testing requirements will be stated on the sample. It is anticipated that the Contractor will perform between 2,000 and 10,000 analyses per year. Natural disasters or military mobilization may alter these estimates.

When the contract laboratory is performing sample analyses using the methodologies specified in Technical Exhibit B, the contract laboratory shall follow quality control guidelines specified in that method.

5.2.3.3 Quality Control Data: Quality control data shall be analyzed and, where they are found to be outside pre-defined criteria, planned actions shall be taken to correct the problem and to prevent incorrect results from being reported. If additional quality assurance/quality control protocol is designated in the methodologies, these guidelines shall also be strictly followed.

5.2.3.4 Holding times: Analyze samples within the maximum holding times specified in the method, even if these times are less than the 21 day for Standard, 12 day for High Priority or eight (8) day Top Priority report delivery TATs required in this contract.

If a sample is not processed within the specified holding time per method, the sample will be considered “lost”, unable to analyze and require recollection by the DCPH-A client/Project Officer. When this occurs, the Contractor shall not bill the Government for tests performed on samples beyond their holding times and be assessed liquidated damages (for example late penalties) in accordance with the “Liquidated Damages” clause incorporated into this contract. The Contractor shall not be liable if time remaining on the holding times, upon receipt of samples at Contractor, is less than 48 hours. Extenuating circumstances can be negotiated on a case-by-case basis with the DCPH-A COR. (Examples may include – Weekends/Holidays, late arrivals, unannounced arrivals.)

5.2.4 Disposal of unused sample volumes and return of Government shipping containers.

5.2.4.1 Disposal. Unless otherwise instructed by the COR, the Contractor shall be required to dispose of unused sample volumes and used Radiological sampling media (excluding carbon disulfide which shall be disposed immediately) no earlier than 60 days following submission of analytical data to DCPH-A COR. Sample disposal and disposal of unused sample bottles/containers is the responsibility of the Contractor and should be done in accordance with all applicable laws and regulations governing disposal of such materials.

5.2.4.2 Shipping Containers. The Contractor shall return all Government shipping containers, unless otherwise specified, to the COR within three (3) business days of receipt at the cost of the Government who will provide applicable shipping labels for each container.

5.2.5 Surge Capacity. The contractor shall perform analyses on supplied matrices and provide the results showing any radiological compounds in each sample, IAW with the PWS. Potential exists to have other projects unexpectedly come up that will require additional sample analyses. A CLIN will be present in the event there is a surge in needed services to execute those requirements. If the Government elects to exercise a surge CLIN, the Government may elect to incrementally fund or fully fund the CLIN based on the Government’s needs and/or the availability of funding

5.2.6 Liquidated Damages

5.2.6.1. The Contractor shall submit Final and Preliminary reports in an electronic format. If the Contractor does not submit data packages on time and/or submits incomplete/technically deficient/unacceptable data packages, the Contractor may be required to pay liquidated damages (late penalties) to the Government as follows: - 5% per day late to a maximum of 100% of the total invoice price.

5.2.6.2. Extensions for matrix issues and sample analysis anomalies may be negotiated with the COR on a case-by-case basis. However, these issues must be made known to the COR when they occur and when the lab believes a delay is possible, not after the data package is overdue.

5.2.7 Contractor Project Management. Contractor shall manage all assigned projects from initial receipt until project completion. The Contractor shall ensure all projects are completed in accordance with the terms and conditions of the PWS.

5.2.8 Facilities Engineering Services. RESERVED

5.3 Service Contract Reporting. RESERVED

5.4 Laboratory Qualifications and Capabilities

5.4.1.1.1 Gas Chromatographs (GC) with various detectors as required for each method

5.4.1.1.2 High Pressure Liquid Chromatographs (HPLC)

5.4.1.1.3 Ion Chromatographs (IC)

5.4.1.1.4 Inductively Coupled Plasma (ICP)

5.4.1.1.5 Atomic Emission Spectrometers (AES)

5.4.1.1.6 Mass Spectrometers (MS)

5.4.1.1.7 Transmission Electron Microscope (TEM)

5.4.1.1.8 Microscopes

5.4.1.1.9 X-Ray Fluorescence (XRF)

5.4.1.2 Laboratory Facilities (minimum requirements):

5.4.1.2.1 5000 sq. ft. of laboratory space

5.4.1.2.2 Adequate electrical service

5.4.1.2.3 Reagent water to meet ASTM Type II classification

5.4.1.2.4 Class A volumetric glassware for all analyses

5.4.1.2.5 Adequate fume hood system to provide safe storage of hazardous materials

5.4.3 Laboratory Certifications and Qualifications for Radiological Sample Analyses

5.4.3.1 The laboratory where the work is performed shall be ISO 17025 accredited and in compliance with The NELAC Volume 1 Management and Technical Requirements for Laboratories Performing Environmental Analysis: 2016.

5.4.3.2 The Contractor is required to notify the COR, in writing, within 48 hours of changes that result in the loss of any of the required laboratory certifications (to include loss of accreditation in individual methods or analytes). The Contractor shall cease performance of any sample analysis impacted by the loss of laboratory accreditation, until accreditation is restored and evidence of such is provided to the COR. If accreditation is not restored within 30 calendar days from notification, the contract may be terminated for default. The Contractor shall provide the COR with the most current accreditation certificates that relate to this contract within five (5) business days of receipt of the update accreditation certificates.

5.4.4 Quality Documentation: At a minimum, the contract laboratory shall have, in writing, documented procedures (e.g., SOPs) for the following at time of award:

5.4.4.1 Sample receipt, handling, storage and control.

5.4.4.2 Security, chain of custody and document control.

5.4.4.3 Hazardous waste/sample disposal.

5.4.4.4 Sample analysis (to include types of analyses required, sample preparation, modifications to established methods, peculiarities of instrumentation, etc.)

5.4.4.5 Calibration of standards, traceability (show traceability of standards to National Measurement Systems (e.g., National Institute of Standards and Technology))

5.4.4.6 Ongoing or routine laboratory operations (including maintenance of instrumentation, procurement of supplies, scheduling of calibration for balances, thermometers, etc.)

5.4.4.7 Laboratory Safety and Chemical Hygiene (should address wearing of coats, gloves, goggles, handling of hazardous materials, eye lavaging, storage of hazardous materials, safety showers, fire safety, etc.).

5.4.4.8 Lab QA/QC (to include procedures for conducting in house audits; procedures for allowing technicians and chemists to have an independent means of checking the quality of their results; procedures for the development and implementation of contingency plans; and procedures for the initiation of corrective action.

5.4.4.9 Data production, reduction, transcription, verification, review, distribution and in house storage

5.4.4.10 Determination of Reporting Limits. (Contractor must document the criteria under which the reporting limits are established/re-established for each analytical process. Must also include acceptance criteria for such reporting limit evaluation)

5.4.5 Analytical Training Records - All Contractor personnel performing sample handling/processing/analysis in support of this Government contract shall have records demonstrating proficiency in performing the methodologies detailed in Technical Exhibit B.

5.4.6 On-site Inspections - The Government reserves the right to conduct on-site inspections of the Contractor’s and subcontractor’s laboratories to ensure that appropriate processes and quality assurance procedures are being followed in order to ensure that samples are being analyzed in accordance with the standards listed in this PWS, the requirements found in the published method identified by the Contractor, as well as the requirements in the applicable NELAC Volume 1 Management and Technical Requirements for Laboratories Performing Environmental Analysis: 2016 Modules and corresponding checklist(s).

5.4.7 Subcontracting – The following section discusses any Sample analysis performed at a separate location other than the prime contractor’s laboratory location.

5.4.7.1 The Contractor shall be responsible for any subcontract management necessary to integrate work performed on this contract and shall be responsible and accountable for subcontractor performance. The prime Contractor will manage work distribution to ensure there are no Organizational Conflicts of Interest (OCI) considerations. A notification must be sent to the CO and COR within 30 days of the agreement between the prime and the subcontractor.

5.4.7.2 Due to the need to maintain the integrity of the sampling and the laboratory certifications, the Contractor may subcontract with no more than three (3) other laboratories. The subcontractor laboratories and personnel shall hold the same qualifications and certifications as required by the prime. The prime Contractor shall not subcontract more than half of the methods listed in Technical Exhibit B.

5.4.7.3 The Government reserves the right to conduct on-site inspections of the Contractor’s and subcontractor’s laboratories to ensure that appropriate processes and quality assurance procedures are being followed in order to ensure that samples are being analyzed in accordance with the standards listed in this PWS, the requirements found in the published method, as well as the requirements in the applicable accreditation and corresponding checklist(s). The lab(s) use for subcontracting must first be audited to the same standards as the prime and approved by DCPH-A prior to submitting samples. No exceptions to this requirement will be accepted.

5.4.7.4 Sending samples to any location for analysis other than the physical location that is placing the bid is considered subcontracting even if it is within the same corporation.

5.4.7.5 Subcontractor(s) shall adhere to the same quality requirements as the oversight Contractor, to include all applicable sections of this PWS. It should be noted that every time the term “Contractor” is used throughout this PWS, the term “subcontractor” is also applicable.

5.5 Management Reports and Plans

5.5.1 Monthly Financial Tracking Report (Deliverable 9). The Contractor shall provide a spreadsheet with detail of real time expenditure levels of every contract line-item number (CLIN). The initial report is due 30 days after contract award and by the first of each month thereafter.

5.5.2 Results Status Report (Deliverable 10). The Contractor shall provide a weekly summary of all DCPH-A analysis currently being analyzed by the Contractor (to include analysis sent to the subcontractor). The summary shall be provided to the DCPH-A COR on the first business day each week and contain the following information at a minimum. If there are no samples in-house, there is no summary status report is required.

PART 6

APPLICABLE PUBLICATIONS

6. Applicable Publications (Current Editions): The following publications, manuals, regulations, are listed below.

Department of Defense and Department of Energy Quality Systems Manual for Environmental Laboratories (most current version)

U.S. Environmental Protection Agency (EPA) Methods

PART 7

ATTACHMENT AND TECHNICAL EXHIBIT LISTING

7. Attachment and Technical Exhibit List

7.1 Technical Exhibit A – Deliverables Schedule

7.2 Technical Exhibit B – Chemical parameters, Matrix and Detection Limits

7.3 Technical Exhibit C – Final Report and Electronic Data Deliverable (EDD) Requirements

7.4 Technical Exhibit D - Electronic Data Deliverable (EDD) Specifications

TECHNICAL EXHIBIT A

DELIVERABLES SCHEDULE

A.001 Curriculum Vitea’s for Key Personnel (paragraph 1.10)

Once at the post award meeting and no later than 30 days after departure of a key personnel

To the CO and COR

A.002 Non-Disclosure Statements (paragraph 1.18)

To the COR

A.003 Anti-Terrorism (AT) Level 1 INITIAL Training Certificates (paragraph 1.23.1)

To the COR

A.004 Anti-Terrorism (AT) Level 1 REFRESHER Training Certificates (paragraph 1.23.1)

To the COR

A.005 iWatch Training Certificates (paragraph 1.23.3)

To the COR

A.006 Sample Receipt Notifications (paragraph 5.2.1.2)

To the COR

A.007 Final PDF Analytical Report (paragraph 5.2.2)

A.008 Final Electronic Data Deliverable (EDD) (paragraph 5.2.2)

A.009 Monthly Financial Tracking Report (paragraph 5.5.1)

To the COR

A.010 Results Status Report (paragraph 5.5.2)

To the COR

TECHNICAL EXHIBIT B

Chemical Parameters, Matrix and Detection Limits

Technology

TECHNICAL EXHIBIT C

Final Report and Electronic Data Deliverable (EDD) Requirements

Contractor data packages shall include the following documentation:

A. Complete Data Package (Submitted via PDF) – Data package shall comprise the following items:

a. Invoice for Services Rendered – Contractor shall submit a PDF of the invoice for each pick-up order/report submitted.

b. Case Narrative – A summary description of the analytical operations that occurred during sample receipt and analyses. Case narrative should include quality control activities and actions taken by lab personnel to eliminate problem areas identified during sample analyses.

c. Analysis report forms – These forms contain the results from measurement of those chemical parameters that are requested and specified in the Pickup Order/Delivery Order. Data are to be identified by the DCPH-A Lab ID number and the corresponding field number.

d. Sample Receipt Documentation – sample receipt logs, temperature logs, pickup order forms, COC forms.

e. Quality Control Data Summary – This section shall include data from spikes, duplicates, blinds, reagent blanks, system calibrations, etc.

f. Raw data for analytical measurements to include the following:

i. Chemical parameter analyzed; NIOSH, OSHA, or other method description; date of analysis of samples.

ii. Calibration and stock standards (including method of preparation and standardization) with accompanying readings.

iii. Summary sheet to include designation of samples by DCPH-A number

iv. Summary sheets for quality control samples

v. Any instrument adjustments to include periodic base line adjustments or adjustments in attenuation/sensitivity.

vi. Copies of instrument print outs as applicable

vii. Calculation sheet clearly describing how positive results were calculated.

viii. Tabulation of instrument detection/Limit of Quantitation (LOQ) which have been determined by the contract laboratory and reported on Data Report Form. (Raw data must show that at least one standard was analyzed at or below detection limit for data to be valid).

B. PDF Instructions for the Complete “FINAL” Data Package – This PDF document will include the entire data package as described above, minus the invoice. Please provide the invoice via PDF as a separate file from Final report. Final package PDF and invoice PDF are emailed to the following addresses: DHA APG Pub Health - A Mailbox LAB COR at dha.apg.Pub-Health-A.mbx.lab-cor@health.mil and DHA APG Pub Health - A Mailbox DLS-Contract-Hardcopies at dha.apg.Pub-Health-A.mbx.dls-contract-hardcopies@health.mil

C. These will be due no later than 2:00 PM Eastern Standard Time on the due date specified on the Pick-up Order. Naming convention of hard copy file and invoice should at least include the lab queue (acronym) and the DCPH-A Pick up Order number, both of which will be provided on the documentation.

D. Preliminary Sample Analysis Results (pdf file) – Due one day before Complete Hard Copy Data Package pdf, for High and Top Priority Turn Around Time requests (see C.2.2 General Requirements). These preliminary pdfs will contain final, numerical results in appropriate units, for the requested chemical parameters. Sample data shall be identified by DCPH-A lab number and field ID number.

E. Electronic Data Deliverable (EDD) - The electronic data deliverable (EDD) and Final PDF report are REQUIRED to be derived from the same source. Information (sample numbers, field numbers, etc.) and data (analytical results, units) must match. The process that generates the final report and EDD is REQUIRED to be validated to demonstrate that the process provides identical information and data.

a. Note: for instances where site specific matrix spike (MS) / matrix spike duplicates (MSD) are requested, LIMS limitations may not permit EDD reporting of the MS/MSD. Specific directions will be supplied on a case-by-case basis by the COR.

TECHNICAL EXHIBIT D

Electronic Data Deliverable (EDD) Specifications

Tab Delimited Text File Format

Electronic Data Deliverable (EDD)

The electronic copy of the Data Package is commonly referred to as the contract Electronic Data Deliverable or EDD.

The electronic data deliverable (EDD) and hardcopy reports are required to use and have the same information (sample numbers, field numbers, etc.) and data (analytical results, units). The process that generates the hard copy and EDD is required to be validated to demonstrate that the process provides identical information and data.

The EDD will contain quantitated results in appropriate units, or reporting limits, for the requested chemical parameters. Sample data shall be identified by Defense Centers for Public Health – Aberdeen (DCPH-A) lab numbers. Please note that the contractor shall transfer the data electronically from their lab to the DCPH-A lab using the file format described below:

EDD Naming Convention

The database containing the EDD should be named using the following format:

Pickup Order #.txt or Shipment #.txt

Example 1. The EDD for Pickup Order 112 would be as follows:

P112.t…