A02 Request for Information PAN5344 for Posting.pdf

Request for Information (RFI)

Requiring Activity Name: United States Army Medical Directorate Armed Forces Research Institute of Medical Sciences (USAMD - AFRIMS) part of Walter Reed Army Institute of Research (WRAIR) located in Bangkok Thailand.

Subject: Clinical Study Support for Biomedical Research and Surveillance in Kamphaeng Phet, Thailand.

This Request for Information (RFI)/Sources Sought (SS) Notice is for market research information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of USAMD-AFRIMS, WRAIR or the US Army Medical Research Acquisition Activity (USAMRAA).

This market research is seeking sources only that have knowledge and capabilities to provide clinical study support for biomedical research and surveillance in Kamphaeng Phet, Thailand.

The NAICS code for this requirement is 541715 “Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)”.

Only capability statements and/or fact sheet will be accepted.

DISCLAIMER: This RFI is NOT a Request for Proposals (RFP) or a Request for Quotations (RFQ); This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Responses to the RFI will not be returned. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. No Contract will be awarded from this announcement. No reimbursement will be made of any costs to provide information in response to this announcement or any follow up information requests. Responders are solely responsible for all expense associated with responding to this RFI. Availability of any formal solicitation will be announced under a separate announcement.

All information received in response to this RFI will be treated as business confidential information. Submitters should properly mark their responses if the information is confidential. All information received in response to this RFI that is marked Proprietary will be handled accordingly.

At this time, questions concerning the composition and requirements for a future solicitation will not be entertained.

RFI Response and due date: 30 August 2024 10am Eastern Standard Time (EST)

Background: The purpose of this requirement is to provide services associated with scientific/technical, regulatory, epidemiological, clinical, laboratory, administrative, database management, quality assurance, and logistical support to the Kamphaeng Phet - AFRIMS Virology Research Unit (KAVRU) for the conduct of epidemiological, clinical, and laboratory activities related to biomedical research and surveillance projects to take place within (or near) Kamphaeng Phet, Thailand.

Instructions to Responders: Responses from Small Businesses capable and qualified sources are encouraged to respond to this request.

Review the attached DRAFT PWS. Respondents should address how they best can fulfil the requirements set forth in Part 5 of the PWS in their capabilities statement.

Capability Statements or any other proprietary information relative to this RFI should adhere to the following formatting and outline instructions:

1. All submissions shall be made electronically and be in one of the following formats:

Microsoft Word or Adobe PDF and shall not exceed 3 pages (Cover page excluded from page count).

2. Cover Page

• Title

• Organization

• Responders technical and administrative points of contact (names, addresses, phone, fax number and email addresses)

• Topic area(s) addressed

• Respondents shall be able to perform under the NAICS code of 541715.

Address whether the respondent is offering similar or like services in the commercial market to the general public.

3. Please note that the response shall provide sufficient technical data to determine how you fully meet the requirements as specified in the DRAFT Performance Work Statement.

Please note that responses are due no later than 30 August 2024 10am EST. The requested information shall be submitted via email. The point of contact for this action is Jaclyn Svincek, Contract Specialist Jaclyn.p.svincek.civ@health.mil. Only electronic responses are requested. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE.

DRAFT PWS

JUN 22

PERFORMANCE WORK STATEMENT (PWS)

Clinical Study Support for Biomedical Research and Surveillance in Kamphaeng Phet, Thailand 5 July 2024

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 services contract to provide clinical study support for biomedical research and surveillance in Kamphaeng Phet, Thailand.

1.2 Background: The mission of the Walter Reed Army Institute of Research (WRAIR) and its subordinate organization the Armed Forces Research Institute of Medical Sciences (AFRIMS) in Bangkok, Thailand is to conduct and support biomedical research that is responsive to Department of Defense and U.S. Army requirements and delivers lifesaving products including knowledge, technology, and medical materiel that sustain the combat effectiveness of the war fighter. This is a requirement for research services in support of the AFRIMS division of WRAIR.

The United States Army Medical Directorate - Armed Forces Research Institute of Medical Sciences (USAMD-AFRIMS) is an overseas laboratory of the WRAIR. AFRIMS has programs in enteric diseases (infectious causes of diarrhea), malaria vaccine and drug research, viral diseases, an entomology department dedicated to the study of disease vectors and a retrovirology department which has been organized to execute vaccine studies for the human immunodeficiency virus (HIV).

The purpose of this requirement is to provide services associated with scientific/technical, regulatory, epidemiological, clinical, laboratory, administrative, database management, quality assurance, and logistical support to the Kamphaeng Phet - AFRIMS Virology Research Unit (KAVRU) for the conduct of epidemiological, clinical, and laboratory activities related to biomedical research and surveillance projects to take place within (or near) Kamphaeng Phet, Thailand.

AFRIMS KAVRU conducts biomedical research and surveillance in support of the WRAIR mission. KAVRU executes research and surveillance projects focusing on emerging infectious diseases of importance to the U.S. Army including but not limited to dengue and influenza. KAVRU is situated on the grounds of Kamphaeng Phet Hospital (KPPH) which is the Thai Ministry of Public Health (MOPH) referral hospital for Kamphaeng Phet province

(KPP).

1.3 Scope/Period of Performance:

1.3.1 Scope: The Contractor shall provide non-personal service(s). This shall include providing all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform services as described in the Performance Work Statement (PWS) and associated contract documents, except for those items specified in Part 3 Government Property and Services. The Contractor shall perform to the standards and acceptable quality levels identified in this PWS and associated contract documents.

1.3.2 Period of Performance:

Base Period 30 September 2024 – 29 September 2025 Option Period 1 30 September 2025 – 29 September 2026 Option Period 2 30 September 2026 – 29 September 2027 Option Period 3 30 September 2027 – 29 September 2028 Option Period 4 30 September 2028 – 29 September 2029

1.4 Objective: The objective of this contract is to provide non-personal services associated with scientific/technical, regulatory, epidemiological, clinical, laboratory, administrative, database management, quality assurance, and logistical support. This shall include (but not limited to) providing epidemiological and clinical research support services, procurement of supplies and laboratory testing, shipment of supplies and biological specimens, coordination with communities/village centers and schools where the studies will take place, procurement of transportation, maintenance and communications services, and quality control for activities related to the preparation and execution of biomedical research and surveillance projects. This requirement is based on WRAIR / USAMD-AFRIMS’ current mission, as the mission changes, the needs may increase or decrease.

1.5 General Information:

1.5.1 Quality Control Plan (QCP)

The Contractor shall develop and maintain a QCP to ensure services are performed in accordance with (IAW) this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor's QCP is the means by which it assures that the work provided complies with the requirements of the contract.

The Contractor’s Proposed QCP shall be submitted to the Contracting Officer (KO) through the Contracting Officer’s Representative (COR) for review within 10 days after date of contract award (A.001).

The Government will review and either notify the Contractor in writing of acceptance of the plan or return their comments to the Contractor within 30 days. If the Government has provided comments, the Contractor shall then have 30 days to submit a final QCP. After receipt of the final QCP, the Contractor may receive the KO’s acceptance in writing. Any proposed changes to the accepted QCP are required to be resubmitted for acceptance by the KO no later than 30 days prior to the anticipated change and before implementation by the Contractor. The timeline noted above will apply for review and acceptance for proposed changes. At a minimum, the QCP must include and answer the following to be acceptable:

(a) A chart showing the organizational structure and lines of authority, the names, qualifications, duties, responsibilities, and classification of each member of the Contractor's quality control team;

(b) How the Contractor will monitor work to ensure performance complies with all deliverables (etc. timelines, deadlines, and goals);

(c) How the Contractor will monitor work to ensure performance complies with all specifications and requirements of the contract, including the contract’s clauses;

(d) How the Contractor will monitor and ensure staff qualifications remain current and valid including Department of Defense (DoD) Contractor Personnel Office (DOCPER) processes/approvals throughout contract performance;

(e) How the Contractor will ensure all keys issued will remain controlled items, if applicable (paragraph 1.7.7 Key Control);

(f) How the Contractor will inventory and track maintenance of all Government provided equipment/materials, if applicable;

(g) How the Contractor will identify, investigate, and correct any non-conforming performance and prevent similar deficiencies in the future; and

(h) How the Contractor will file and save all quality control related documents for the life of the contract plus five years.

1.5.1.1 Analysis of quality control and timeliness of submittals (i.e., deliverables) shall be provided to the COR within 30 days upon completion of each option period or task order (A.002)

1.5.1.2 The Contractor shall inform the COR of issues or potential issues that might affect the performance within 48 hours of identifying those issues. Verbal reports shall be followed up by written reports within two days (A.003).

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 work day prior to the holiday will apply as the deadline for submittal.

1.5.3.1 U.S. Holidays: Reserved.

1.5.3.2 Host Nation Holidays: The contractor may elect to not perform services on days designated as a Thai government holiday. In addition, KAVRU has their own set of approved holidays, and as such, the contractors will follow the holiday schedule listed below in addition to the list of Thai government holidays.

Chakri Day Songkran Festival Coronation Day Wisakha Bucha Day H.M. King Maha Vajiralongkorn’s

Birthday Bodindradebayavarangkun’s

Birthday Makha Bucha Day Royal Ploughing Ceremony Khao Phansa Day

H.M. The Queen’s Birthday Chulalongkorn Day H.M. late King Bhumibol

Adulyadej’s Birthday Constitution Day New Year’s Eve/New Year Labor Day Asahna Bucha Day Mother’s day Passing of late King

Bhumibol

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: Reserved

1.5.4.2 Government Facility Operating Hours: Reserved.

1.5.4.3 Contractor Support Hours: Reserved

1.5.4.3.1 Contractor Work Plan: Reserved.

1.5.5 Training Holidays: Reserved.

1.6 Place of Performance: Work will be performed at KAVRU, the KAVRU Clinical support Area (CSA), Kamphaeng Phet public health facilities, or in the Kamphaeng Phet community in accordance with study sponsor(s) and/or approved protocols as needed to accomplish the objectives of the protocols.

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

1.7.1 Security Program: Reserved.

1.7.2 Personnel Security Clearance Requirements: Reserved.

1.7.3 Installation Access: Reserved.

1.7.3.1 Installation Pass Log: Reserved.

1.7.3.2 Individual Termination or Expiration of Employment: Reserved.

1.7.3.3 Contract Termination or Cancellation: Reserved.

1.7.3.4 Common Access Cards (CAC) and CAC Log: Reserved.

1.7.4 Background Checks: Reserved.

1.7.4.1 U.S. Citizen: Reserved.

1.7.5 Physical Security: The Contractor shall safeguard all Government equipment, information, and property provided for Contractor use.

1.7.6 Operations Security (OPSEC) Requirements: Reserved.

1.7.7 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.

The Contracting Officer, COR, and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings the Contracting Officer 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 management, 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 Contracting Officer, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the Contractor by the Contracting Officer. 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 order. 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 Contracting Officer and Contractor of any deficiencies, coordinate availability of Government property, and coordinate site entry of Contractor personnel.

1.10 Key Personnel: The following positions have been identified to be filled by Key Personnel proposed for this award.

Key Personnel Position Minimum Requirements Program Manager Prior experience as a program manager, preferably with government contracts.

The Contractor shall provide key personnel IAW the minimum requirements listed within the Key Personnel table above.

Substitutions of proposed key personnel shall not be allowed for a period of six months after award, except under extreme circumstances. Any substitution or replacement key personnel shall have the necessary experience and knowledge required to perform the duties defined herein. For temporary and/or permanent replacement of key personnel, the Contractor shall provide a resume for each individual to the COR. Resumes shall be provided at least two weeks (or as mutually agreed upon) prior to making any personnel changes. The Government reserves the right to pre-approve any replacement or substitution of key personnel. Contractor personnel must submit necessary information to be issued a clearance prior to reporting for performance. Substitution or replacement personnel shall be replaced within 30 days (A.004).

Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of an agreement by the key personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

The Contractor shall provide a Program/Contract Manager who shall be responsible for the performance of the work. The name of this person and an Alternate Program/Contract Manager, who shall act for the Contractor when the Program/Contract Manager is absent, along with a Curriculum Vitae (CV) for each of these individuals, shall be provided in writing to the KO no later than five days after contract award. Acceptance of the CV by the KO is required before these individuals are permitted to perform any task on this contract. The

Contract Manager and Alternate Contract Manager shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract (A.004).

1.11 Identification of Contractor Employees: All Contractor personnel attending meetings, answering Government telephones, and working in other situations where their Contractor status is not obvious to third parties must identify themselves, to include proper marking of signature blocks in correspondence, to avoid creating an impression in the minds of members of the public that they are Government officials. The Contractor shall ensure that all documents or reports, produced by Contractors are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

1.11.1 Contractor Workspace: Reserved.

1.11.2 Contractor Identification Badges: Reserved.

1.12 Contractor Travel: All travel, including local travel (3-4 trips from Kamphaeng Phet to Bangkok or a third location within Thailand) or international travel (1-2 trips for international travel possibly in the U.S.), shall be pre-approved by the COR and is on a strictly cost reimbursable basis, and must meet Joint Travel Regulation (JTR) and the limitation of funds specified in this contract. Costs for travel shall be billed in accordance with the regulatory implementation of Public Law 99-234 and FAR 31.205-46 Travel Costs, subject to local policy and procedures. All travel requires government approval and authorization 30 days prior to travel (A.005)

Period From To Round

Trip (Y/N)

# of Trips

# of People

# of Days

Base year and all 4 option years

Kamphaeng Phet

Bangkok Y 2 2 3

Base year and all 4 option years

Kamphaeng Phet

USA Y 1 2 7

1.13 Other Direct Costs (ODCs): Other Direct Costs (ODCs) are anticipated in support of travel, supplies, materials, printing, shipping expenses, training activities, and visits to sites that may be required in support of this requirement. ODCs shall be billed on a cost reimbursable basis. The Contractor shall manage and account for all costs associated with requirements labeled as ODCs, not to exceed the price ceiling listed in this contract. The Contractor shall attach back up information to receiving reports for direct labor and ODCs.

The Contractor shall provide a monthly financial report describing details of real-time expenditure levels of the ODC contract line-item number (CLIN). The report is due monthly to be submitted together with the invoice (A.006)

1.13.1 Invoices: The contractor shall submit invoices monthly to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice (A.007).

The contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The contractor shall attach back up information to receiving reports for ODCs.

Backup information for ODCs shall list all elements of costs. All ODCs exceeding $3,000 requires the contractor to conduct appropriate competition and obtain approval from the COR prior to purchase. Equipment purchases are not authorized under this contract. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

Where applicable, contractor will include additional ODC invoice details as required per protocol for any volunteer payments in support of this PWS.

1.14 Data Rights: The Government has unlimited rights to all documents and materials produced under this contract. All documents and materials, to include the source codes of software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership and copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the Contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.15 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 Contracting Officer. 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.

1.15.1 Non-Disclosure Statements: Reserved.

1.16 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.

1.17 Organizational Conflict of Interest (OCI): Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications, or work statements, etc.) or perform evaluation services which may create a current or subsequent OCI as defined in FAR Subpart 9.5. The http://www.dimoc.mil/resources/limitations/

Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s OCI Mitigation Plan will be determined to be acceptable solely at the discretion of the Contracting Officer. In the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI. (A.008)

1.18 Phase In /Phase Out Period: Reserved.

1.19 Safety: Reserved.

1.19.1 Safety Laws and Regulations: Reserved.

1.20 Environmental Compliance: Reserved.

1.20.1 Environmental Compliance Plan and Program: Reserved.

1.21 Required Training: Reserved.

1.21.1 Anti-Terrorism (AT) Level I Training: Reserved.

1.21.2 OPSEC Training: Reserved.

1.21.3 iWATCH Training: Reserved

1.21.4 Information Assurance (IA) Training. Reserved.

1.21.5 Personally Identifiable Information (PII): Reserved.

1.22 Authorization to Perform Services in Thailand

1.22.1 Contractors performing services in Thailand shall comply with Thai law. The Contractor shall determine whether performance requires registration with the Thai authorities or authorization to do business in Thailand and, if so, shall comply with all requirements.

Whether or not registration or authorization to do business is required, the Contractor shall determine what documents or authorization its employees and any subcontractor employees must possess to work in Thailand. The Contractor shall ensure affirmatively that its employees and subcontractor employees possess such documents or authorizations.

1.22.2 Contractor employees who: (a) are not nationals of Thailand; or (b) are not members of the US military the civilian component or their dependents shall possess work and residence permits.

1.22.3 By acceptance of and performance under this contract, the Contractor affirms that it has complied with the requirements above. Compliance with this requirement and Thai law is a material contract requirement. Noncompliance by the Contractor or subcontractor at any tier shall be grounds for issuing a negative past performance evaluation and terminating this contract for default.

1.23 Notice to Proceed: Reserved.

1.24 Electromagnetic Compatibility Directive: Reserved.

1.25 Government Property and Services: Reserved.

1.26 Conventional Forces Europe (CFE) Treaty Verification Inspection: Reserved.

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 – 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 DFARS 202.101, means an individual designated and authorized in writing by the Contracting Officer 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 Contracting Officer 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.

Contractor-acquired Property - means property acquired, fabricated, or otherwise provided by the Contractor for performing a contract and to which the Government has title.

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 Performance Work Statement.

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

Government-Furnished Property – As reflected in FAR 52.245-1, Government-furnished Property “means property in the possession of, or directly acquired by, the Government and subsequently furnished to the Contractor for performance of a contract. Government-furnished property includes, but is not limited to, spares and property furnished for repair, maintenance, overhaul, or modification. Government-furnished property also includes contractor-acquired property if the contractor-acquired property is a deliverable under a cost contract when accepted by the Government for continued use under the contract

Government Property - means all property owned or leased by the Government. Government property includes both Government-furnished and Contractor-acquired property. Government property includes material, equipment, special tooling, special test equipment, and real property. Government property does not include intellectual property and software.

Property Administrator - means an authorized representative of the Contracting Officer appointed in accordance with agency procedures, responsible for administering the contract requirements and obligations relating to Government property in the possession of a Contractor.

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 Performance Work Statement (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 Day - The number of hours per day the Contractor provides services in accordance with the contract.

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.

ACOR Alternate Contracting Officer's Representative AE Adverse Events AFARS Army Federal Acquisition Regulation Supplement AFRIMS Armed Forces Research Institute of Medical Sciences AR Army Regulation AT Anti-terrorism CAC Common Access Card CFR Code of Federal Regulations CLIN Contract Line-Item Number CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer’s Representative CRO Clinical Research Organization DA Department of the Army DD250 Department of Defense Form 250 (Receiving Report) DD254 Department of Defense Contract Security Requirement List DFARS Defense Federal Acquisition Regulation Supplement DoD Department of Defense EC Ethical Committees FAR Federal Acquisition Regulation FTE Full Time Equivalent FVBI Febrile and Vector-Borne Illness GFP Government Furnished Property GPS Global Positioning System IA Information Awareness ID Identification IRB Institutional Review Boards IT Information Technology JTR Joint Travel Regulation KAVRU Kamphaeng Phet AFRIMS Virology Research Unit KO Contracting Officer KPP Kamphaeng Phet province KPPH Kamphaeng Phet Hospital MOPH Ministry of Public Health OCI Organizational Conflict of Interest OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs OPSEC Operations Security PA Property Administrator PI Principal Investigator PII Personally Identifiable Information PIPO Phase In/Phase Out

POC Point of Contact PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program RA Requiring Activity SAE Serious Adverse Events SAM System for Award Management SCR Service Contract Report SOP Standard Operating Procedures TE Technical Exhibit WRAIR Walter Reed Army Institute of Research

PART 3

GOVERNMENT PROPERTY (GP) AND SERVICES

3. Government Property and Services

3.1 Services: Reserved.

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: The Government will provide the following training: training necessary for ethical and/or regulatory compliance to meet Government human clinical studies requirements.

3.8 Common Access Cards (CAC): Reserved.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. Contractor Furnished Property and Services

4.1 General: The Contractor shall furnish personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform services as described in the PWS and associated contract documents, except for those items specified in Part 3 Government Property and Services. The Contractor shall provide facility space for all studies and related activities as well as storage space for documentation and supplies during the duration of trials. Areas for specimen collection and/or investigational products must conform to safety and storage guidelines appropriate for the area.

4.2 Secret Facility Clearance: Reserved.

4.3 Materials: The Contractor shall purchase, as ODCs, all materials, supplies, reagents, and services needed to execute the tasks in this PWS.

4.4 Vehicles and Equipment: Reserved.

4.5 Background Checks: Reserved.

PART 5

SPECIFIC TASKS

5.1 Basic Services: The contractor shall provide services associated with scientific/technical, regulatory, epidemiological, clinical, laboratory, administrative, database management, quality assurance, and logistical support for biomedical research and surveillance projects.

5.2 Tasks: Tasks consist of the following:

5.2.1 Contract Management: The contractor shall manage the contract properly and in a timely manner. The contractor shall:

5.2.1.1 Ensure that all deliverables are met in a timely manner and coordinate with KAVRU and/or the COR for any issues.

5.2.1.2 Assist on any procurement, reimbursement travel, meeting and logistical arrangement.

5.2.1.3 Provide proper supporting documentation upon invoice submission. (A.007)

5.2.1.4 Provide annual performance reports. (A.009) The contractor shall provide a report describing any problems encountered (regulatory, compliance, financial, logistical, etc.)

during the study period. The report shall include current status and any potential or projected issues that may arise in future option periods.

5.2.2 Ground and Facility Maintenance: The Contractor shall provide administrative, logistical, maintenance and security support to KAVRU grounds, its facility, and its staff. The Contractor shall provide periodical reports (A.006, A.007, A.009) describing activities and expenditures related to:

5.2.2.1 Providing space for all studies and related activities and storage space for document and supplies during the duration of a trial.

5.2.2.2 Providing and maintaining security and safety at KAVRU, including physical security, security guards, and fire prevention.

5.2.2.3 Providing facility and grounds repair, maintenance, upkeep, and other relevant activities at KAVRU, which shall include the KAVRU building, its clinical subject area, electricity and electrical wiring, water pipeline and waste,water maintenance and support, and internet and wireless communication.

5.2.2.4 Maintaining direct LAN lines at KAVRU.

5.2.2.5 Furnishing diesel or gasoline fuel to KAVRU vehicles operating in support of KAVRU projects.

5.2.2.6 Purchasing supplies, reagents, and services needed to execute this task.

5.2.2.7 Attenging the face-to-face meeting with AFRIMS Virology as required.

5.2.2.8 Providing venues adequate for meetings or training events which are attended by AFRIMS personnel, or personnel from clinical site and others. Providing travel related to site visits/meetings, training, conferences, workshop, and presentation in support of this contract.

5.2.2.9 Providing network (e.g., internet, landlines, etc.) connectivity to KAVRU.

5.2.3 Clinical Trial Epidemiological Task Area: The contractor shall support KAVRU in the execution of prospective epidemiology studies. The contractor shall provide services associated with the execution of prospective studies, as outlined in related protocol(s). The contractor shall:

5.2.3.1 Provide the required Principal Investigator (PI) and clinical support staff, including clinical researchers, nurses, and laboratory technicians, at Kamphaeng Phet public health facilities or in the Kamphaeng Phet community and associated clinics and hospitals for the execution of an arboviral epidemiological study that enroll and test up to 500 subjects in the Kamphaeng Phet and adjacent areas.

5.2.3.2 Provide active surveillance of up to 500 study subjects and collect samples and data from all acute and corresponding convalescent samples (calculated at about 10% of all subjects yearly).

5.2.3.3 Purchase supplies, reagents, and services needed to execute this task.

5.2.3.4 Provide support, as required by KAVRU, for subject recruitment, enrollment, active follow-up, interviewing, maintenance of study-related documentation, and periodical clinical examination of subjects.

5.2.3.5 Collect biological specimens including but not limited to blood, respiratory swabs, urine, and others as determined by study. Collect and maintain all data including but not limited to epidemiological, clinical, laboratory, and other data as relevant. (A.010)

5.2.3.6 Process, store, and transfer samples to KAVRU for shipment to AFRIMS in Bangkok. (A.011)

5.2.3.7 Maintain electronic and hardcopy files for work products, including all clinical protocol associated documents, associated reference material, and data for the duration of the contract. Develop, implement, and maintain a database (or catalogue) of files accessible and reportable to the Government and Government designees upon notification from the COR relevant to the projects.

5.2.3.8 Provide visit reimbursement and call reimbursement to subjects as approved by the Institutional Review Boards (IRB).

5.2.3.9 Provide training for necessary personnel in order to implement studies to ensure compliance with required institutional class or on-line training and other trainings required by AFRIMS, the sponsor, or assigned Clinical Research Organization (CRO). (A.012)

5.2.3.10 In coordination with AFRIMS, submit all study-related material to all relevant local Ethical Committees (EC) or Institutional Review Boards (IRB) and respond to their queries and obtain approvals.

5.2.4 Clinical Trial Support Task Area. The contractor shall support KAVRU in the execution of arboviral clinical and investigational trial studies. The Contractor shall provide services associated with the execution of interventional studies, as outlined in related protocol(s). This task area is currently being utilized under contract number W81XWH22C0064 with an expected start date on this contract on or about 14 July 2025.The Contractor shall:

5.2.4.1 Provide the required PI and clinical support staff, including clinical researchers, pharmacists, nurses, and laboratory technicians at Kamphaeng Phet public health facilities or in the Kamphaeng Phet community and associated clinics and hospitals for the execution of arboviral epidemiological studies that enroll and follow up to 2,048 subjects in the Kamphaeng Phet and adjacent areas.

5.2.4.2 Provide active surveillance of the study subjects defined as twice weekly after intervention and collect samples and data from all acute and corresponding convalescent samples calculated at about 10% of all subjects yearly.

5.2.4.3 Purchase supplies, reagents, and services needed to execute this task.

5.2.4.4 Assist with import permits related to investigational product, as needed.

5.2.4.5 Provide support, as required by KAVRU, for subject recruitment, enrollment, active follow-up, interviewing, maintenance of study-related documentation, and periodical clinical examination of subjects.

5.2.4.6 Collect biological specimens including but not limited to blood, respiratory swabs, urine, and others as determined by study. Collect and maintain data including but not limited to epidemiological, clinical, laboratory, and other data as relevant. (A.010)

5.2.4.7 Periodically process, store, and transfer specimens to Kamphaeng Phet public health facilities. (A.011)

5.2.4.8 Maintain electronic and hardcopy files for work products including all clinical protocol associated documents, associated reference material, and data for the duration of the contract. Develop, implement, and maintain a database (or catalogue) of files accessible and reportable to the Government and Government designees upon notification from the COR relevant to the projects.

5.2.4.9 Provide visit reimbursement, as approved by IRB, and call reimbursement to subjects.

5.2.4.10 Provide training for personnel involved in the studies in order to implement studies to ensure compliance with required institutional class or on-line training and other trainings required by AFRIMS, the sponsor or assigned CRO (A.012).

5.2.4.11 Provide study document translations as required (A.013).

5.2.4.12 Provide administrative management, reporting, and clinical care and treatment where appropriate, of all research-related Adverse Events (AE) and Serious Adverse Events (SAE) that occur during the trial in accordance with protocol directives and specific Standard Operating Procedures (SOPs) (A.014).

5.2.4.13 Ensure facilities are maintained in a manner allowing a safe and orderly research environment including patient-waiting areas, private interview areas, specimen collection areas and other required areas as per protocol/SOP. Areas for specimen collection and/or investigational products must conform to safety and storage guidelines appropriate for the area.

5.2.5 Dengue Epidemiological Task Area: The contractor shall support KAVRU in the execution of a longitudinal dengue cohort study. This task area is currently being utilized under contract number W81XWH22C0064 with an expected start date on this contract on or about 14 July 2025.

5.2.5.1 Provide the required clinical support staff including clinical researchers and nurse support at KPPH and associated sub districts, and community health workers for the execution of a dengue epidemiological study that enrolls and follows up to 3,500 subjects in KPP province.

5.2.5.2 Provide support, as required by KAVRU, for subject recruitment, enrollment, active follow-up, interviewing, maintenance of study-related documentation, and periodical clinical examination of subjects.

5.2.5.3 Collect biological specimens (i.e., blood, respiratory swabs, urine, others as relevant) and data (i.e., epidemiological, clinical, laboratory, others as relevant) and periodically process, store, and transfer to KAVRU. (A.010, A.011)

5.2.5.4 Maintain files (electronic and hardcopy) for work products (including all clinical protocol associated documents), associated reference material, and data for the duration of the contract. Develop, implement, and maintain a database (or catalogue) of files accessible and reportable to the Government and Government designees upon notification from the COR relevant to the projects.

5.2.5.5 Provide visit reimbursement, as approved by IRB, and call reimbursement to subjects.

5.2.5.6 File directly with the Thai Ministry of Public Health all study-related documentation, which are required for the initiation and execution of the study.

5.2.5.7 Provide training for personnel involved in the studies in order to implement studies to ensure compliance with requiring institutional class or on-line training and other trainings required by AFRIMS, the sponsor, or assigned CRO. (A.012)

5.2.6 Respiratory, Febrile, and Vector-Borne Illness (FVBI) Study

5.2.6.1 The Contractor shall provide services associated with the execution of surveillance and Public Health Testing Support Requests issued by district and sub district hospitals, and clinics within KPP province. T This task area is currently being utilized under contract number W81XWH22C0064 with an expected start date on this contract on or about 14 July 2025. The Contractor shall:

5.2.6.2 Provide the required clinical support staff, including clinical researchers and nurse support at KPPH to support public health testing requests.

5.2.6.3 Collect the required biological specimens (i.e., blood, respiratory swabs, urine, and others as relevant) for arboviral or respiratory testing and all relevant data (i.e., epidemiological, clinical, laboratory, and other data as relevant) and process, store, and transfer to KAVRU. (A.010, A.011)

5.2.6.4 Provide training for personnel involved in the studies to ensure compliance with institutional, IRB/EC or CRO required on-line training and web-based conferencing, certification, and other trainings. (A.012)

5.2.7 Auxiliary Support and Non-Clinical Study: This task area is currently being utilized under contract number W81XWH22C0064 with an expected start date on or about 14 July 2025.

5.2.7.1 Coordinate with KAVRU staff and generate Global Positioning System (GPS) data and coordinates from subjects addresses (at time of enrollment or at time of infection) that have entered current or past studies in KPP province and subjects that are part of public health testing support requests (A.015).

5.2.7.2 Collect (trap, following generally accepted methods) speciate mosquitoes (adults or larval) in areas identified by KAVRU staff. Deliver to KAVRU both mosquitoes collected (in vials) and speciation data. (A.016)

5.2.7.3 KHIP Study: Provide the required principal investigator (PI), clinical support staff, including clinical researchers, pharmacists, nurses, laboratory technicians and such at Kamphaeng Phet public health facilities or in the Kamphaeng Phet community and associated clinics and hospitals for the execution of clinical trials studies that enroll and follow (up to 15 visits per subject over 5 years) up to 400 subjects in the Kamphaeng Phet and adjacent areas per study.

5.2.7.4 MV181 Study: Provide the required principal investigator (PI), clinical support staff, including clinical researchers, pharmacists, nurses, laboratory technicians and such at Kamphaeng Phet public health facilities or in the Kamphaeng Phet…