Draft PWS.docx

Defense Health Agency Performance Work Statement (PWS)

Pacific Region Force Health Protection Vector-borne Disease Agent Surveillance Research & Development (R&D) in External Proficiency Testing

Theater Preventive Medicine Flight

18th Medical Group, Kadena Air Force Base

Solicitation Number: Version:

Date: 14 April 2026

DHA PWS Template V13 November 16, 2021

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide Pacific Region Force Health Protection Vector-borne Disease Agent Surveillance R&D in External Proficiency Testing.

1.2 Description of services/introduction: The contractor shall develop safe and validated external proficiency testing procedures for the detection of pathogens in arthropods (mosquitoes). This effort supports reliable diagnostic capabilities through performance-based external quality assurance using non-infectious agents to minimize risk.

1.3 Background: Vector-borne diseases transmitted by arthropods, such as dengue and malaria, continue to pose significant threats to U.S. military forces, particularly in deployed and austere environments. The Theater Preventive Medicine Flight conducts surveillance of arthropods to detect human pathogens and supports quality assurance programs that ensure the accuracy and reliability of diagnostic testing.

Given the complexity of insect vectors and the pathogens they carry, a rigorous quality assurance program is essential for producing reliable results that inform public health decision-making. External Quality Assurance (EQA) programs—also known as proficiency testing—involve laboratories periodically testing unknown samples provided by a third party. This process independently verifies diagnostic capabilities and identifies areas for improvement.

There is a need to develop external quality tests that utilize non-infectious agents. This approach minimizes risk while enabling broader implementation as part of a multi-layered framework of good laboratory practices, standardized protocols, and external validation.

1.4 Objectives:

(1) Develop a Written Manual/Protocol for Safe External Proficiency Testing

(2) Validate the Proficiency Testing Protocol

(3) Demonstrate Proficiency Test Performance Characteristics

(4) Provide Analysis of Field-Expedient Capability

1.5 Scope: The scope of work is limited to the research, development, validation, and documentation of safe external proficiency testing procedures as described in the high-level objectives above. Work shall be performed exclusively at the contractor’s laboratory facilities. The Government will provide limited virus-free mosquito samples for use in confirmation testing; the contractor is not required to collect samples or perform testing of operational/field-collected arthropod pools.

1.6 Period of Performance (PoP): SEE SCHEDULE

1.7 Administrative specifications

1.7.1 Place of performance: All services shall be performed at contractor’s facility.

1.7.2 Recognized Federal holidays: The contractor is or is not required to perform services on holidays.

1.7.3 Hours of operation: The contractor is responsible for conducting business Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.7.4 Emergency Services: RESERVED

1.8 Contractor travel: RESERVED

1.9 Other Direct Costs (ODC): RESERVED

1.10 Quality

1.10.1 Quality Control Plan (QCP): The contractor shall develop and maintain an effective QCP to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor’s QCP is the means by which the work complies with stated requirements. (Deliverable 1)

1.10.2 Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.11 Contractor personnel: RESERVED

1.12 Key personnel (Contractor): RESERVED

1.13 Data rights: All data, reports, manuals, procedures, validation documentation, test results, and other materials first produced or delivered under this contract shall be subject to the Rights in Data clause incorporated into the contract (FAR 52.227-14 or applicable DFARS clause). The Government intends to obtain unlimited rights in all deliverables and data developed under this effort to support force health protection programs, quality assurance implementation, and potential transition to other contractors or DoW activities. The contractor shall not assert restricted or limited rights in any deliverable unless pre-approved in writing by the Contracting Officer and properly marked in accordance with the clause. All deliverables shall be delivered free of proprietary restrictions that would prevent full Government use, reproduction, or disclosure as needed for public health, policy development, or follow-on efforts.

1.14 Reporting RESERVED

1.15 Contractor Identification RESERVED

1.16 Contractor Access to Health Affairs (HA)/DHA Network(s) RESERVED

1.17 Personnel Security RESERVED

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE PUBLICATIONS/INSTRUCTIONS

2.1 Definitions.

2.1.1 Category D: Information Technology (IT) and Telecommunications Services (called D-Services)

2.1.2 Category R: Support (Professional/Administrative/Management) Services (called R-Services)

2.1.3 Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.1.4 Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated and authorized in writing by the CO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.5 Nonpersonal services contract: a contract under which the personnel rendering the services 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.

2.1.6 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.

2.2 Acronyms:

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Requiring Activity Authority has assessed the need for Government Furnished Property, Equipment, and Services and determined:

3.1 Services: The Government:

☒Will NOT provide Government Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐WILL provide Government Furnished Services required in support of this contract/task orders. These Services are described below:

3.2 Facilities: The Government:

☒Will NOT provide Facilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐WILL provide Facilities in support of this contract/task orders. The Government provided Facilities are described below

3.3 Utilities: The Government:

☒Will NOT provide Utilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐WILL provide Utilities in support of this contract/task orders. The Government provided Utilities are described below:

3.4 Equipment: The Government:

☒Will NOT provide Equipment in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐WILL provide Equipment in support of this contract/task orders. The Government provided Equipment is described below:

3.4.1 Procurement Integrated Enterprise (PIEE), GFP Module Application The contractor shall be responsible for obtaining and maintaining access, training and successful operation of the PIEE/GFP Module application for the entirety of the contract/task order PoP. The PIEE GFP Module application is located at the following website: https://wawf.eb.mil/piee-landing/. Access to PIEE/GFP Module application training materials and in-depth information applicable to the contractor’s responsibilities regarding GFP can be found at the following website: https://dodprocurementtoolbox.com/.

Contracting Office Responsibilities:

The Contracting Office shall ensure close coordination and validation of the GFP items with the COR and DHA Accountable Property Officer prior to uploading the GFP Attachment into the PIEE/GFP Module. At the time GFP is anticipated and identified, the Government will upload the GFP Attachment into the PIEE/GFP Module. It is the Contracting Office’s responsibility to prepare, upload and maintain the GFP Attachment in the PIEE/GFP Module in accordance with the GFP Attachment instructions provided at the DoD Procurement Toolbox. The CO and COR shall manage and keep an inventory of any GFP associated with contract/task orders awarded through DHA, in accordance with applicable FAR Part 45, DoD FAR Supplement (DFARS) 245 with respective clauses, DHA AI 095 and PD 45-01 following the change in disposition of items listed on that PIEE/GFP Module Attachment.

The contracting office will also review, acknowledge, reject and/or approve shipment orders provided by the contractor as appropriate. Functional roles can be determined within the Contracting Office, and requested within the PIEE/GFP Module system.

Contractor Responsibilities:

A key contractor responsibility is to work with the CO and COR to ensure the PIEE/GFP Module data, to include the PIEE/GFP Attachment, provides a timely, complete and accurate accounting of the GFP applicable to the contract/task order. Contractors are required to report the receipt of any GFP shipped to them, regardless of whether it is listed on the GFP Attachment for their contract. Similarly, contractors are required to utilize the GFP Module application in conjunction with the shipment of GFP to the Government, or in reporting Property Loss of GFP issued (such as destruction or loss). Discrepancies or disputes regarding property shipped to or shipped from the contractor must be reported via the GFP Module application, with the CO having authority over final designation of status.

The contractor shall report semi-annually 100% inventories, reconciliations, and final disposition of GFP provided by the government. Final invoices will not be paid pending GFP reconciliation. Contractors shall be aware of and ensure compliance with applicable FAR Part 45, DFARS 245 and 252.245, Defense Pricing and Contracting Policies, Procurement Integrated Enterprise Environment Standards, DHA Administrative Instruction 094 and DHA Guidance.

3.5 Materials: The Government:

☐Will NOT provide Materials in support of this contract/task order. As a result, this paragraph is Not Applicable.

☒IS providing Materials in support of this contract/task orders. The Government-provided Materials are described below: The Government will provide limited virus-free mosquito samples for use in confirmation testing. The contractor shall coordinate with the Government for receipt of any limited virus-free mosquito samples needed for confirmation testing.

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 Services: The Contractor:

☒Will NOT provide Contractor Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐WILL provide Contractor Furnished Services required in support of this contract/task orders. These Services are described below: provide

4.2 General: RESERVED

4.3 Secret Facility Clearance: RESERVED

4.4 Materials: RESERVED

4.5 Equipment: RESERVED

4.6 Facilities: RESERVED

PART 5

5.0 SPECIFIC TASKS

5.1 Performance Objective 1: Develop a Written Manual/Protocol for Safe External Proficiency Testing. The contractor shall develop a comprehensive, standalone written manual or standard operating procedure (SOP) that describes how to create, prepare, and use safe, transportable external quality assurance/proficiency test materials for the detection of human pathogens in arthropods (mosquitoes), without the use of live or cultured pathogenic organisms.

Sub-objectives:

(1) The manual shall focus on the use of partial nucleic acid constructs or synthetic/non-infectious materials as the proficiency test analyte.

(2) Dengue virus detection via qRT-PCR shall serve as an acceptable model, with the protocol adaptable to other relevant arthropod-borne pathogens.

(3) The manual shall include detailed procedures for: preparation of proficiency test materials, safe handling and transport, integration into a laboratory quality assurance program, and steps to minimize biosafety risks.

(4) The manual shall be submitted in Word or PDF format via email and shall be clear, technically accurate, and suitable for use by DoW preventive medicine laboratories.

5.2 Performance Objective 2: Validate the Proficiency Testing Protocol. The contractor shall rigorously validate the developed protocol using standard laboratory protocol validation processes for molecular diagnostic assays to ensure it is "fit for purpose."

Sub-objectives:

(1) Validation shall establish performance specifications for accuracy, precision, analytical sensitivity, analytical specificity, and any other relevant parameters per accepted guidelines for laboratory-developed molecular assays.

(2) The contractor shall perform internal validation testing using constructed proficiency test materials.

(3) All validation activities shall be documented in a validation report, including methods, raw data, statistical analysis, and conclusions.

5.3 Performance Objective 3: Demonstrate Proficiency Test Performance Characteristics. The contractor shall provide statistically valid proficiency testing results that demonstrate the limit of detection (LOD), sensitivity, and specificity of the developed external proficiency test materials and associated detection methods.

Sub-objectives:

(1) Testing shall include a minimum of 60 samples (as referenced in the requirement) containing the constructed proficiency test analytes, using verified virus-free mosquitoes or arthropod matrices provided in part by the Theater Preventive Medicine Flight.

(2) Results shall include quantitative or qualitative data (as applicable) showing LOD, sensitivity (true positive rate), and specificity (true negative rate), with appropriate statistical measures (e.g., confidence intervals, reproducibility data).

(3) Testing shall confirm the protocol's ability to support reliable detection without infectious materials.

5.4 Performance Objective 4: Provide Analysis of Field-Expedient Capability. The contractor shall conduct and report an initial analysis of the proficiency test analyte's and protocol's capability for use in field-expedient conditions.

Sub-objectives:

(1) The analysis shall evaluate factors such as: stability/transportability of the partial nucleic acid constructs, ease of use with portable or minimal equipment (e.g., field-adaptable qRT-PCR platforms), robustness to environmental variables (temperature, humidity, dust), and overall practicality for DoD preventive medicine teams.

(2) The report shall identify any limitations, recommended mitigations, and potential adaptations for austere use.

5.5 Performance Objective 5: Monthly Progress Reporting. The contractor shall provide regular progress updates to ensure timely delivery of all required deliverables.

Sub-objectives:

(1) Submit monthly progress reports (via email) summarizing accomplishments, issues, risks, and upcoming activities throughout the period of performance.

(2) All reports shall be prepared in Microsoft Word or PDF format.

(3)

PART 6

6.0 INFORMATION TECHNOLOGY & SECURITY

6.1 All work under this contract is unclassified.

6.2 Personally Identifiable Information (PII)/Protected Health Information (PHI), Procurement, and Federal information requirements are not applicable for this requirement.

6.3 Training - RESERVED

6.4 Cybersecurity Requirements for Non-DoD IT or Covered Contractor IS:

6.5 Risk Management Framework (RMF) for DoD IT: RESERVED

6.6 Facility Related Control Systems: RESERVED

6.7 System Communications – RESERVED

6.8 MHS Demilitarized Zone (DMZ) Medical Community of Interest (MedCOI) Business-to-Business (B2B) Gateway - RESERVED

6.9 Contractor Provided IT Infrastructure – RESERVED

6.10 System Authorization Access Request (SAAR), Defense Department (DD) Form 2875 - RESERVED

6.11 MHS Systems Telecommunications – RESERVED

6.12 Establishment of Telecommunications – RESERVED

6.13 Contractors Located On Military Installations – RESERVED

PART 7

7.0 ATTACHMENTS/TECHNICAL EXHIBIT LISTING

7.1 Attachment and Technical Exhibit List:

7.2 Technical Exhibit A – Performance Requirements Summary

7.3 Technical Exhibit B – Deliverables Schedule

PART 7.2, TECHNICAL EXHIBIT A

PERFORMANCE REQUIREMENTS SUMMARY

PART 7.3, TECHNICAL EXHIBIT B

DELIVERABLES SCHEDULE

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