B01. Combined Synopsis_Solicitation HT942524Q0030.pdf

HT942524Q0030

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, in conjunction with the policies and procedures for solicitation, evaluation and award prescribed in FAR Part 13-Simplified Acquisition Procedures, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and no other solicitation will be issued.

The NAICS code is 541380, Testing Laboratories, with a size standard of $19M. This is a requirement issued under full and open competition. All capable vendors are encouraged to submit a quote.

The US Army Medical Research Acquisition Activity (USAMRAA) requests responses from qualified sources capable of industrial hygiene sample analysis in accordance with the Performance Work Statement (PWS).

PWS

PERFORMANCE WORK

STATEMENT (PWS)

Title: Lab Industrial Hygiene (IH) Sample Analysis Contract

Requiring Activity Name: Defense Centers for Public Health – Aberdeen (DCPH-A) (Formerly known as the US Army Public Health Center – APHC)

1. INTRODUCTION

The Defense Centers for Public Health – Aberdeen (DCPH-A) is part of the Defense Health Agency (DHA) and focuses on epidemiology, laboratory sciences, occupational health sciences, public health information and toxicology to enhance military readiness and assure the quality and effectiveness of the Public Health Enterprise. Ensuring high-quality services is an imperative of the DCPH-A as it strives to become a high-reliability organization (HRO).

2. PURPOSE AND BACKGROUND

The mission of the DCPH-A is to “Enhance Military readiness by identifying and assessing current and emerging health threats; developing and communicating public health solutions; and assuring the quality and effectiveness of the Public Health Enterprise.” As part of the DCPH-A mission, the Lab Sciences Directorate performs Industrial Hygiene Sample Analysis in support of the Military operating environments and military bases to ensure the safety and security of all who work there.

The Lab Sciences (LS) Directorate currently analyzes industrial hygiene and occupational samples for various parameters in support of the DCPH-A mission. However, the LS does not currently have the analytical capability and/or capacity to perform all industrial hygiene analyses required including analyses from various worldwide locations and from natural or man-made disaster locations.

3. SCOPE

The DCPH-A requires analyses on Industrial Hygiene and Occupational Health samples and results of various compounds in each sample.

The data obtained under this contract shall be used by the DHA to comply with Federal and State requirements of the Occupational Safety and Health Administration (OSHA).

Procedures specified in Attachment 3 - Limits of Quantitation and Attachment 4 - Final Reporting Requirements, shall be used in the analyses on Industrial Hygiene and Occupational Health samples.

If the referenced standard procedures have been modified in any way (sample preparation, analysis, types and number of Quality Control (QC) samples employed, QC acceptance criteria, etc.), these modifications must be clearly explained in the laboratory Standard Operating Procedures (SOPs) and provided to DCPH-A prior to contract award for approval. Contractor shall employ safe handling techniques and quality assurance/quality control protocol. In addition, strict adherence to chain-of-custody and quality control procedures is required at all times.

Procedures specified in Attachment 3 - Limits of Quantitation and Attachment 4 - Final Reporting Requirements, shall be used in the analyses on Industrial Hygiene and Occupational Health samples.

If the referenced standard procedures have been modified in any way (sample preparation, analysis, types and number of Quality Control (QC) samples employed, QC acceptance criteria, etc.), these modifications must be clearly explained in the laboratory Standard Operating Procedures (SOPs) and provided to DCPH-A prior to contract award for approval. Contractor shall employ safe handling techniques and quality assurance/quality control protocol. In addition, strict adherence to chain-of-custody and quality control procedures is required at all times.

4. PERIOD OF PERFORMANCE

This contract is for one (1) twelve (12) month Base Period and four (4) twelve (12) month option periods.

Base Year 1 April 2024 – 31 March 2025 Option Year 1 1 April 2025 – 31 March 2026 Option Year 2 1 April 2026 – 31 March 2027 Option Year 3 1 April 2027 – 31 March 2028 Option Year 4 1 April 2028 – 31 March 2029

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

The work location is at the Contractor’s or Sub-Contractor’s laboratory facility.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

To provide Industrial Hygiene sample analysis in accordance with the parameters identified with various types of samples.

6.2. Specific Tasks / Requirements

6.2.1. Objective 1 – The Contractor shall perform analysis on Industrial Hygiene samples provided by the Government. The Contractor shall follow Chain-Of-Custody (COC) procedures as defined in the contractor’s COC Standard Operating Procedure (SOP).

6.2.1.1. Key Task 1 – Receipt and Storage of Samples prior to analysis. The Government will send 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 the analytical method specifications.

Samples will be provided to the Contractor either through from DCPH-A or shipment directly from the field.

6.2.1.1.1 Sample Shipment Protocol from the DCPH-A lab. If applicable, DCPH-A shall pay the shipping costs for transportation of the samples. The Contractor shall store samples in accordance with the preservation guidelines as noted in the analytical method until samples are analyzed, and thereafter until results are approved by the COR.

6.2.1.1.2 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 Chain-of- Custody (COC) document to the contract lab.

6.2.1.1.3 When the contract lab receives the samples and corresponding field COC forms, the Contractor 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 LIMS login at the DCPH-A (Deliverable 1). The contractor’s project manager will 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 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 Contractor 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. The contractor shall immediately report all samples lost or broken in shipment, with as much detail as possible, to the COR. In addition, the sample receipt temperature must be reported to the COR if applicable within 24 hours of sample receipt (Deliverable 2).

6.2.1.2 Key Task 2 – Perform Sample Analysis within the stated Turnaround Time

(TAT). The Government will designate samples as either “STANDARD”, “HIGH PRIORITY”, “TOP PRIORITY”, or “URGENT”. Turnaround times 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 transmission within the following TAT timeframes:

STANDARD: Maximum 8 calendar days from date of sample receipt.

HIGH PRIORITY: Maximum 5 calendar days from the date of sample receipt.

TOP PRIORITY: Maximum 3 calendar days from the date of sample receipt.

URGENT: Maximum 1 calendar day from date of sample receipt.

Turnaround time is defined as the intervening time period 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 + Electronic Data Deliverable (EDD)), (Attachment 4), 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.

If a report is identified as not technically acceptable, the COR will notify the Contractor to obtain a revision or clarity. In cases where the revision is due to a problem caused by the Contractor, the TAT will continue from the date the Contractor is notified of the revision request. If the revision is due to a government change (such as a change in the sample ID requiring a revised report), the Contractor TAT clock will not continue.

Approximately 15% 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. Urgent shall be defined as samples involved in a catastrophic national emergency situation; less than 0.5% of samples, if any, could be classified as urgent.

Provide final analytical results to the COR. The contractor shall submit the results of all analyses within the TAT timelines as defined on the Outsource Document for each set of samples (Deliverable 3). The results shall be submitted electronically to the COR and include the information requested in the format outlined in the Final Reporting Requirements (Attachment 4).

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.

6.2.1.3 Key Task 3 – Provide Quality sample Analysis on Industrial Hygiene Samples for various parameters as identified in this PWS in accordance with the documented methodology.

6.2.1.3.1 Use industry standard state-of-the-art instrumentation, technologies and methodologies to analyze samples for any of the parameters listed in Attachment 3 – Limits of Quantitation. Any special analyses or additional testing requirements will be stated on the sample. It is anticipated that the contractor will perform between 500 and 2,500 analyses per year. Natural disasters or military mobilization may alter these estimates to an increased amount at or above 5,000 analyses per year.

When the contract laboratory is performing sample analyses using the methodologies specified in Attachment 3 – Limits of Quantitation, the contract laboratory shall follow quality control guidelines specified in that particular method and American Industrial Hygiene Association (AIHA) accreditation requirements.

6.2.1.3.2 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.

6.2.1.3.3 Analyze samples within the maximum holding times specified in the method, even if these times are less than the 8 calendar day, 5 calendar day or 3 calendar day completion times allowed 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 project officer. When this occurs, the contractor shall not bill the government for tests performed on samples beyond their holding times Extenuating circumstances can be negotiated on a case by case basis with the COR. (Examples – Weekends/Holidays, late arrivals, unannounced arrivals.)

The Contractor shall at least report at or below the limits identified in Attachment 3 - Limits of Quantitation.

6.2.1.4 Key Task 4—Disposal of unused sample volumes and return of

Government shipping containers.

Unless otherwise instructed by the COR, the Contractor shall be required to dispose of unused sample volume and used industrial hygiene sampling media (excluding carbon disulfide which shall be disposed immediately) no earlier than 60 days following submission of analytical data. 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.

All Government shipping containers, unless otherwise specified, shall be returned to the COR within three business days of receipt. The Government will provide return shipping labels to the Contractor for the shipping containers to be returned back to the Government.

6.2.1.5 Key Task 5 – Sampling Media Request for Support

The DCPH-A COR may request the Contractor to supply media only (no subsequent analysis will be ordered). The Contractor shall invoice the Government for the price of the media, and the DCPH-A will provide the shipping account to ship the media if requested.

For Sample analysis being requested by DCPH-A and performed at the Contractor, the Contractor price of the test should include the media required for analysis listed in Attachment 3 – Limits of Quantitation. The Government will request this media on an as needed basis (not for every set of samples).

6.2.1.6 Key Task 6 – Liquidated Damages assessment for late or deficient reporting.

The Contractor shall submit Final and Preliminary reports as well as electronic.

If the contractor does not submit data packages on time and/or submits incomplete/technically deficient data packages, the contractor may be required to pay liquidated damages to the Government as follows:

- 5% per day late to a maximum of 100%

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.

6.3 Laboratory Qualifications and Capabilities

Laboratory Instrumentation/Technology Requirements. The contractor must have the following instrumentation/technologies to ensure the contractor’s ability to process sample analyses within a timely manner based on the anticipated volume:

6.3.1 Instrumentation/Technology (minimum requirements to perform the required testing methods)

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

b) High Pressure Liquid Chromatographs (HPLC)

c) Ion Chromatographs (IC)

d) Inductively Coupled Plasma (ICP)

e) Atomic Emission Spectrometers (AES)

f) Mass Spectrometers (MS)

g) Transmission Electron Microscope (TEM)

h) Microscopes

i) X-Ray Fluorescence (XRF)

6.3.2 Laboratory Facilities (minimum requirements):

a) Adequate electrical service.

b) Reagent water to meet American Society for Testing and Materials (ASTM) Type II classification.

c) Class A volumetric glassware for all analyses.

d) Adequate fume hood system to provide safe storage of hazardous materials.

6.3.3 Laboratory Certifications and Qualifications for Industrial Hygiene Sample Analyses

The contract laboratory shall be accredited by the American Industrial Hygiene Association Laboratory Accreditation Program (AIHA LAP) for analyzing industrial hygiene samples for all analysis required in this contract Schedule of Services. Also, the contract laboratory shall have and provide demonstrated proficiency in the appropriate fields of testing for two consecutive Proficiency Testing (PT) rounds from an AIHA- LAP approved PT Program in accordance with AIHA LAP requirements defined in the AIHA LAP, LLC Policy Module 6 The accreditation certifications and qualification of the contract laboratory will be reviewed to determine acceptance prior to contract award. If accreditation certification and/or qualification are changed due after an offer is placed and prior to contract award, the Contracting Officer (KO) must be notified within 48 hours. Loss and/or changes in the laboratory’s accreditation(s) may result in a technically unacceptable evaluation of a potential contract laboratory.

6.3.4 The contractor is required to notify the COR, in writing, within 48 hours of changes that a 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 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 updates accreditation certificates.

6.3.5 Quality Documentation: At a minimum, the contract laboratory shall have, in writing, documented procedures (e.g. Standing Operating Procedures) for the following:

6.3.5.1 Sample receipt, handling, storage and control.

6.3.5.2 Security, chain of custody and document control.

6.3.5.3 Hazardous waste/sample disposal.

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

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

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

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

6.3.5.8 Lab Quality Assurance (QA)/Quality Control (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.

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

6.3.5.10 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)

6.3.6 Analytical Training Records

All Contractor personnel performing sample handling/processing/analysis in support of this Government contract shall have records demonstrating proficiency in performing methodologies detailed in Attachment 3 – Limits of Quantitation.

6.4 On-Site Laboratory 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 appropriate standards, the requirements found in the published method, as well as the requirements in the applicable The NELAC Institute (TNI) Modules and corresponding checklist(s).

6.5 Subcontracting.

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 Conflict of Interest (OCI) considerations. A notification must be sent to the KO and COR within 30 days of the agreement between the prime and the subcontractor.

Due to the need to maintain the integrity of the sampling and the laboratory certifications, the contractor may subcontract with no more than three 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 Attachment 3 – Limits of Quantitation.

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 appropriate standards, the requirements found in the published method, as well as the requirements in the AIHA Accreditation and corresponding checklist(s). The lab(s) used 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.

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

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

6.6 Management Reports and Plans

6.7.1 Monthly Financial Tracking Report (Deliverable 5). The contractor shall provide a spreadsheet with 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.

6.7.2 Results Status Report (Deliverable 6). The contractor shall provide a weekly summary of all DCPH-A analysis currently being analyzed by the Contractor. A weekly summary is still to be provided to the Government if analyses are not being completed due to samples not arriving in that given week.

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:

6.7.2.1 Outsource Report Number

6.7.2.2 Pick Up Order Number

6.7.2.3 DCPH-A assigned Due date

6.7.2.4 Status of the Report – i.e. on-time, delayed, etc.

6.7.2.5 If the report will be provided after the DCPH-A assigned due date, a projected completion date must be provided.

7. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below.

Unless specified in the PWS within the description of the deliverable, all deliverables shall be made to the COR electronically.

DELIVERABLES TABLE

PWS Ref. Number Title/Description Due

6.2.1.1.3 Deliverable 1 When the contract lab receives the samples and corresponding field COC forms, the Contractor 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 LIMS login at the

DCPH-A

Upon receipt of samples

6.2.1.1.3 Deliverable 2 The contractor shall immediately report all samples lost or broken in shipment, with as much detail as possible, to the COR. In addition, the sample receipt temperature must be reported to the COR if applicable within 24 hours of sample receipt

Within 24 hours

6.2.1.2. Deliverable 3 Results of Analyses With each set of samples submitted for analysis

Attachment 4 Deliverable 4 Electronic Data Deliverable With each set of samples submitted for analysis

6.7.1 Deliverable 5 Monthly Financial Tracking Report. The

Contractor shall complete and deliver a monthly Financial Tracking Report.

Monthly (by the first day of each month)

6.7.3 Deliverable 6 Results Status Report First working day of each week

7.1. Reports and Documents

Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared ensuring electronically produced documents reflect logical flow of material, for example the tables of contents, indexes, and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

7.2. Inspection and Acceptance

The COR delegated oversight of specific technical, functional and oversight responsibilities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the PWS and all terms and conditions of this contract, including all modifications.

7.3. COR Information

TBD upon contract award

8. GOVERNMENT FURNISHED PROPERTY

Not Applicable

9. Contract Management

9.1. Government Management

The COR for this contract will be appointed by the KO. The COR will serve as the primary Government point of contact (POC) for all activities and issues that occur under this contract. Only the KO has the authority to enact changes to this award.

9.2. Contractor Management

The contractor shall designate a single authorized POC with the COR. The POC will be responsible for coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract.

9.3. Contractor Organization

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

9.4. Subcontract management

9.4.1. The contractor is responsible for any subcontract management necessary to integrate services performed on this contract.

9.4.2. The contractor is responsible and accountable for subcontractor performance on this contract.

9.4.3. The contractor is responsible to manage task distribution to ensure there are no OCI considerations.

9.4.4. Contractor may add subcontractors to their team after notification and written approval from the KO.

9.4.5. Privy of contract is with the contractor and the subcontractor.

10. COMPLIANCE DOCUMENTS

10.1. General Compliance

10.1.1. Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), and Medical Command (MEDCOM) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

Federal regulations governing regulations for human subject’s protection are found in 45 CFR 46.

The International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials.

10.1.2. DoD Compliance Documents

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at https://www.esd.whs.mil/dd/

a) Title 21, CFR Part 11 Electronic Records: Electronic Signature.

11. OTHER TERMS, CONDITIONS, AND PROVISIONS

11.1. Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the KO immediately.

11.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

11.3. Inherently Governmental Functions

This requirement has been reviewed and contains no services that are inherently governmental functions.

11.4. Invoices

The contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. Equipment purchases are not authorized under this contract.

11.5. Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any Sub Contractors who have a need to know, of information developed under this order or contained in the reports to be furnished pursuant to this order without prior written approval of the COR or the Contracting Officer.

11.6. Contractor Identification

The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts. Contractors may not use or allude to former or current military rank during the performance of this work.

11.7. Attendance at Meetings

Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract or assistance agreement representatives to meet the requirements of this order.

Contractor personnel shall make their contractor status known during introductions.

11.8. Data Rights

All data received, processed, evaluated, loaded, and created as a result of this contract shall remain the sole property of the Government and shall be returned to the Government at the conclusion of the contract, unless the KO grants a specific exception.

11.9. Compliance with Relevant DoD, Service, and Institutional Policy Regulations.

The Contractor shall comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and all relevant DoD/USG regulations for collection, storage, and transfer of sensitive data and PHI. In addition, the Contractor will comply with all requirements for communication of findings and publication in the scientific peer reviewed literature (e.g.

Public Affairs clearance and Operational Security clearance for dissemination).

11.10. Personally Identifiable Information (PII) and Protected Health Information (PHI)

The contractor shall comply with the DHA Procedures, and Information (PGI) 224 – Protection of Privacy and Freedom of Information, revised 17 May 2015. The contractor may access PII in the course of task response to the requirements of this contract, as such the contractor shall comply with the document entitled “Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Requirements”.

The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data. The Contractor shall also ensure the confidentiality, integrity, and availability of Government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with DFARS Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoDI 5400.11, “DoD Privacy and Civil Liberties Programs,”, and DoD 5400.11- R, “DoD Privacy Program.” The contractor shall also comply with federal laws relating to freedom of information and records management. The Contractor shall comply with all requirements of HIPAA (Pub. L. 104-191), as implemented by the HIPAA Privacy and Security Rules codified at 45 CFR Parts 160 and 164, and as further implemented within the Military Health System (MHS) by DoD 6025.18-R, "DoD Health Information Privacy Regulation," and DoD 8580.02-R, “DoD Health Information Security Regulation.

Information Technology (IT) services that collect, maintain, use, or disseminate personally identifiable information must be managed in a manner that protects privacy, in accordance with section 552a of Title 5, U.S.C. (Reference (aa)), DoD 5400.11 (Reference (ab)) and DoD 5400.11-R (Reference (ac)). DoDI 5400.16 (Reference (ad)) established the guidance for development, review, and approval of Privacy Impact Assessments, in accordance with chapter 36 of Title 44, U.S.C. (Reference (ae)).

12. ATTACHMENTS

ATTACHMENT 1 – ACRONYMS LIST

Acronym Definition

AKO Army Knowledge Online

APHC Army Public Health Center

AT OPSEC Antiterrorism and Operational Security

CAC Common Access Card

CFR Code of Federal Regulations

CONUS Continental United States

COR Contracting Officer Representative

DCPH-A Defense Centers for Public Health - Aberdeen

DFARS Defense Federal Acquisition Regulation Supplement

DoD Department of Defense

FAR Federal Acquisition Regulation

FPCON Force Protection Condition

GFE Government Furnished Equipment

GFI Government Furnished Information

OCI Organizational Conflict of Interest

OCONUS Outside Continental United States

OPSEC Operational Security PWS Performance Work Statement

QASP Quality Assurance and Surveillance Plan

SHARP Sexual Assault Prevention and Response Program

SOP

TNI

Standing Operating Procedure The NELAC Institute

UIC Unit Identification Code

US United States

WAWF Wide Area Work Flow

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Job Industrial Hygiene Sample Analysis

FFP

Sample analysis services FOB: Destination

PSC CD: Q301

NET AMT

0002 1 Job Custom EDD Prep Services

FFP

Custom Electronic Data Deliverable (EDD) Prep Services

0003 1 Job Industrial Health Media

FFP

Industrial Health Media priced per media type requested (price ceiling)

0004 1 Job OPTION Surge Industrial Hygiene Sample Analysis

FFP

Surge Sample analysis services

0005 1 Job OPTION Surge Custom EDD Prep Services

FFP

Surge Custom Electronic Data Deliverable (EDD) Prep Services

0006 1 Job OPTION Surge Industrial Health Media

FFP

Surge Industrial Health Media priced per media type requested (price ceiling)

1001 1 Job OPTION OY1 Industrial Hygiene Sample Analysis

FFP

Option Year 1 Sample analysis services

1002 1 Job OPTION OY1 Custom EDD Prep Services

FFP

Option Year 1 Custom Electronic Data Deliverable (EDD) Prep Services

1003 1 Job OPTION OY1 Industrial Health Media

FFP

Option Year 1 Industrial Health Media priced per media type requested (price ceiling)

1004 1 Job OPTION OY1 Surge IH Sample Analysis

FFP

Option Year 1 Surge Sample analysis services

1005 1 Job OPTION OY1 Surge Custom EDD Prep Services

FFP

Option Year 1 Surge Custom Electronice Data Deliverable (EDD) Prep Services

1006 1 Job OPTION OY1 Surge Industrial Health Media

FFP

Option Year 1 Surge Industrial Health Media priced per media type requested (price ceiling)

2001 1 Job OPTION OY2 Industrial Hygiene Sample Analysis

FFP

Option Year 2 Sample analysis services

2002 1 Job OPTION OY2 Custom EDD Prep Services

FFP

Option Year 2 Custom Electronic Data Deliverable (EDD) Prep Services

2003 1 Job OPTION OY2 Industrial Health Media

FFP

Option Year 2 Industrial Health Media priced per media type requested (price ceiling)

2004 1 Job OPTION OY2 Surge IH Sample Analysis

FFP

Option Year 2 Surge Sample analysis services

2005 1 Job OPTION OY2 Surge Custom EDD Prep Services

FFP

Option Year 2 Surge Custom Electronic Data Deliverable (EDD) Prep Services

2006 1 Job OPTION OY2 Surge Industrial Health Media

FFP

Option Year 2 Surge Industrial Health Media priced per media type requested (price ceiling)

3001 1 Job OPTION OY3 Industrial Hygiene Sample Analysis

FFP

Option Year 3 Sample analysis services

3002 1 Job OPTION OY3 Custom EDD Prep Services

FFP

Option Year 3 Custom Electronic Data Deliverable (EDD) Prep Services

3003 1 Job OPTION OY3 Industrial Health Media

FFP

Option Year 3 Industrial Health Media priced per media type requested (price ceiling)

3004 1 Job OPTION OY3 Surge IH Sample Analysis

FFP

Option Year 3 Surge Sample analysis services

3005 1 Job OPTION OY3 Surge Custom EDD Prep Services

FFP

Option Year 3 Surge Custom Electronic Data Deliverable (EDD) Prep Services

3006 1 Job OPTION OY3 Surge Industrial Health Media

FFP

Option Year 3 Surge Industrial Health Media priced per media type requested (price ceiling)

4001 1 Job OPTION OY4 Industrial Hygiene Sample Analysis

FFP

Option Year 4 Sample analysis services

4002 1 Job OPTION OY4 Custom EDD Prep Services

FFP

Option Year 4 Custom Electronic Data Deliverable (EDD) Prep Services

4003 1 Job OPTION OY4 Industrial Health Media

FFP

Option Year 4 Industrial Health Media priced per media type requested (price ceiling)

4004 1 Job OPTION OY4 Surge IH Sample Analysis

FFP

Option Year 4 Surge Sample analysis services

4005 1 Job OPTION OY4 Surge Custom EDD Prep Services

FFP

Option Year 4 Surge Custom Electronic Data Deliverable (EDD) Prep Services

4006 1 Job OPTION OY4 Surge Industrial Health Media

FFP

Option Year 4 Surge Industrial Health Media priced per media type requested (price ceiling)

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 0002 Destination Government Destination Government 0003 Destination Government Destination Government 0004 Destination Government Destination Government

0005 Destination Government Destination Government 0006 Destination Government Destination Government 1001 Destination Government Destination Government 1002 Destination Government Destination Government 1003 Destination Government Destination Government 1004 Destination Government Destination Government 1005 Destination Government Destination Government 1006 Destination Government Destination Government 2001 Destination Government Destination Government 2002 Destination Government Destination Government 2003 Destination Government Destination Government 2004 Destination Government Destination Government 2005 Destination Government Destination Government 2006 Destination Government Destination Government 3001 Destination Government Destination Government 3002 Destination Government Destination Government 3003 Destination Government Destination Government 3004 Destination Government Destination Government 3005 Destination Government Destination Government 3006 Destination Government Destination Government 4001 Destination Government Destination Government 4002 Destination Government Destination Government 4003 Destination Government Destination Government 4004 Destination Government Destination Government 4005 Destination Government Destination Government 4006 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 01-APR-2024 TO

31-MAR-2025

N/A US ARMY PUBLIC HEALTH CENTER - MM

US ARMY PUBLIC HEALTH CENTER - MM

5158 BLACKHAWK ROAD

BLD E5165

ABERDEEN PROVING GROU MD 21010-

HT1240

0002 POP 01-APR-2024 TO

31-MAR-2025

N/A (SAME AS PREVIOUS LOCATION)

0003 POP 01-APR-2024 TO

N/A (SAME AS PREVIOUS LOCATION)

0004 POP 01-SEP-2024 TO

N/A (SAME AS PREVIOUS LOCATION)

0005 POP 01-SEP-2024 TO

N/A (SAME AS PREVIOUS LOCATION)

0006 POP 01-SEP-2024 TO

N/A (SAME AS PREVIOUS LOCATION)

1001 POP 01-APR-2025 TO

31-MAR-2026

N/A (SAME AS PREVIOUS LOCATION)

1002 POP 01-APR-2025 TO

N/A (SAME AS PREVIOUS LOCATION)

1003 POP 01-APR-2025 TO

N/A (SAME AS PREVIOUS LOCATION)

1004 POP 01-APR-2025 TO

N/A (SAME AS PREVIOUS LOCATION)

1005 POP 01-APR-2025 TO

N/A (SAME AS PREVIOUS LOCATION)

1006 POP 01-APR-2025 TO

N/A (SAME AS PREVIOUS LOCATION)

2001 POP 01-APR-2026 TO

31-MAR-2027

N/A (SAME AS PREVIOUS LOCATION)

2002 POP 01-APR-2026 TO

N/A (SAME AS PREVIOUS LOCATION)

2003 POP 01-APR-2026 TO

N/A (SAME AS PREVIOUS LOCATION)

2004 POP 01-APR-2026 TO

N/A (SAME AS PREVIOUS LOCATION)

2005 POP 01-APR-2026 TO

N/A (SAME AS PREVIOUS LOCATION)

2006 POP 01-APR-2026 TO

N/A (SAME AS PREVIOUS LOCATION)

3001 POP 01-APR-2027 TO

31-MAR-2028

N/A (SAME AS PREVIOUS LOCATION)

3002 POP 01-APR-2027 TO

N/A (SAME AS PREVIOUS LOCATION)

3003 POP 01-APR-2027 TO

N/A (SAME AS PREVIOUS LOCATION)

3004 POP 01-APR-2027 TO

N/A (SAME AS PREVIOUS LOCATION)

3005 POP 01-APR-2027 TO

N/A (SAME AS PREVIOUS LOCATION)

3006 POP 01-APR-2027 TO

N/A (SAME AS PREVIOUS LOCATION)

4001 POP 01-APR-2028 TO

31-MAR-2029

N/A (SAME AS PREVIOUS LOCATION)

4002 POP 01-APR-2028 TO

N/A (SAME AS PREVIOUS LOCATION)

4003 POP 01-APR-2028 TO

N/A (SAME AS PREVIOUS LOCATION)

4004 POP 01-APR-2028 TO

N/A (SAME AS PREVIOUS LOCATION)

4005 POP 01-APR-2028 TO

N/A (SAME AS PREVIOUS LOCATION)

4006 POP 01-APR-2028 TO

N/A (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.203-3 Gratuities APR 1984 52.203-12 Limitation On Payments To Influence Certain Federal

Transactions

JUN 2020

52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper

MAY 2011

52.204-7 System for Award Management OCT 2018 52.204-13 System for Award Management Maintenance OCT 2018 52.204-16 Commercial and Government Entity Code Reporting AUG 2020 52.204-18 Commercial and Government Entity Code Maintenance AUG 2020 52.204-21 Basic Safeguarding of Covered Contractor Information

Systems

NOV 2021

52.212-4 Contract Terms and Conditions--Commercial Products and Commercial Services

NOV 2023

52.217-5 Evaluation Of Options JUL 1990 52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 252.201-7000 Contracting Officer's Representative DEC 1991 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights DEC 2022 252.203-7005 Representation Relating to Compensation of Former DoD

Officials

SEP 2022

252.204-7000 Disclosure Of Information OCT 2016 252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7008 Compliance With Safeguarding Covered Defense Information

Controls

OCT 2016

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting

JAN 2023

252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support

JAN 2023

252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services

JAN 2023

252.204-7019 Notice of NIST SP 800-171 DoD Assessment Requirements NOV 2023 252.204-7020 NIST SP 800-171 DoD Assessment Requirements NOV 2023 252.204-7024 Notice on the Use of the Supplier Performance Risk System MAR 2023 252.205-7000 Provision Of Information To Cooperative Agreement Holders JUN 2023 252.209-7004 Subcontracting With Firms That Are Owned or Controlled By

The Government of a Country that is a State Sponsor of Terrorism

MAY 2019

252.215-7007 Notice of Intent to Resolicit JUN 2012 252.215-7008 Only One Offer DEC 2022 252.215-7013 Supplies and Services Provided by Nontraditional Defense

Contractors

JAN 2023

252.219-7003 Small Business Subcontracting Plan (DOD Contracts) DEC 2019 252.223-7008 Prohibition of Hexavalent Chromium JAN 2023 252.225-7012 Preference For Certain Domestic Commodities APR 2022 252.225-7055 Representation Regarding Business Operations with the

Maduro Regime

MAY 2022

252.225-7056 Prohibition Regarding Business Operations with the Maduro Regime

JAN 2023

252.225-7059 Prohibition on Certain Procurements from the Xinjiang Uyghur Autonomous Region - Representation

JUN 2023

252.225-7060 Prohibition on Certain Procurements from the Xinjiang Uyghur Autonomous Region

JUN 2023

252.225-7972 (Dev) Prohibition on the Procurement of Foreign-Made Unmanned Aircraft Systems (DEVIATION 2020-O0015)

MAY 2020

252.225-7973 (Dev) Prohibition on the Procurement of Foreign-Made Unmanned Aircraft Systems - Representation (DEVIATION 2020- O0015)

MAY 2020

252.226-7001 Utilization of Indian Organizations, Indian-Owned Economic Enterprises, and Native Hawaiian Small Business Concerns

JAN 2023

252.227-7015 Technical Data--Commercial Products and Commercial Services

MAR 2023

252.227-7037 Validation of Restrictive Markings on Technical Data JAN 2023 252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

DEC 2018

252.232-7010 Levies on Contract Payments DEC 2006 252.237-7010 Prohibition on Interrogation of Detainees by Contractor

Personnel

JAN 2023

252.243-7001 Pricing Of Contract Modifications DEC 1991 252.243-7002 Requests for Equitable Adjustment DEC 2022 252.244-7000 Subcontracts for Commercial Products or Commercial

Services

NOV 2023

252.247-7023 Transportation of Supplies by Sea JAN 2023

CLAUSES INCORPORATED BY FULL TEXT

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services-- Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications- Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services."

(d) Representations. The Offeror represents that--

(1) It [ ___ ] will, [ ___ ] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that--

It [ ___ ] does, [ ___ ] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision.