A02 Request for Information Biomedical Clinical and Surveillance Studies Bangkok.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: Biomedical, Clinical, and Surveillance Studies for Respiratory Viruses in Bangkok.

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 biomedical, clinical, and surveillance support in Bangkok, Thailand at Phramongkutklao Hospital (PMK) where studies and projects are being implemented.

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 RFP will not be entertained.

RFI Response and due date: 14 June 2024 4pm Eastern Standard Time (EST)

Background: The purpose of this requirement is to provide services associated with scientific/technical, clinical, epidemiological, laboratory, administrative, database management, and logistical support required by biomedical, clinical, and surveillance studies and projects related to respiratory viruses being conducted at Phramongkutklao Hospital (PMK) in Bangkok, 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 section 6 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.

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 14 June 2024 4pm 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

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

Biomedical, Clinical, and Surveillance Studies for Respiratory Viruses in Bangkok for

The United States Army Medical Directorate - Armed Forces Research Institute of Medical Sciences (USAMD-AFRIMS)

4 January 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 service(s) contract to provide biomedical, clinical, and surveillance support in Bangkok, Thailand.

1.2 Background:

The United States Army Medical Directorate - Armed Forces Research Institute of Medical Sciences (USAMD-AFRIMS) is an overseas laboratory of the Walter Reed Army Institute of Research (WRAIR). AFRIMS has received global recognition of being a World Health Organization (WHO) Collaborating Center for diagnostic reference, training, and investigation of emerging infectious diseases and has been involved in the specimen collection as part of the Department of Defense (DoD) Influenza Surveillance Program since 1996.

AFRIMS has participated in the DoD Influenza Surveillance Program in Southeast (SE) Asia since 1996. AFRIMS is located near the grounds of Phramongkutklao Hospital (PMK), which has led to several successful collaborations, including two vaccine trials on dengue and ongoing respiratory surveillance studies. PMK has been approved by Institutional Review Boards (IRBs) to conduct sentinel human influenza surveillance studies and is sufficiently staffed and equipped to provide clinical management and sample collection as described in approved protocols.

The purpose of this requirement is to provide services associated with scientific/technical, clinical, epidemiological, laboratory, administrative, database management, and logistical support required by biomedical, clinical, and surveillance studies and projects related to respiratory viruses being conducted in Bangkok.

1.3 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.

1.3.1 Period of Performance:

Base Year: 24 September 2024 – 23 September 2025 Option Year One: 24 September 2025 – 23 September 2026 Option Year Two: 24 September 2026 – 23 September 2027 Option Year Three: 24 September 2027 – 23 September 2028 Option Year Four: 24 September 2028 – 23 September 2029

1.4 Objective: The objective of this contract is to collect and characterize respiratory viruses circulating within the human population in Thailand. The contractor shall collect samples, perform required laboratory services, and provide clinical/demographic data and laboratory results and specimens to AFRIMS.

1.5 General Information:

1.5.1 Quality Control Plan (QCP):

The Contractor’s existing quality assurance system shall be utilized In Accordance With (IAW) Federal Acquisition Regulation (FAR) 12.208.

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 Host Nation Holidays: The contractor may elect to not perform services on holidays designated by the Thai Government listed below.

- Chakri Day

- Songkran Festival

- Coronation Day

- Wisakha Bucha Day

- H.M. King Maha Vajiralongkorn’s Birthday

- Bodindradebayavarangkun’s Birthday

- H.M. The Queen’s Birthday

- Chulalongkorn Day

- H.M. late King Bhumibol Adulyadej’s Birthday

- Constitution Day

- New Year’s Eve/New Year

- Makha Bucha Day

- Royal Ploughing Ceremony

- Khao Phansa Day

- 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. 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: The Contractor shall provide support between the hours of 0800 and 1700 Monday through Friday. The Contractor shall maintain an adequate workforce, for the uninterrupted performance of all tasks defined within this PWS. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce is essential.

1.5.4.3.1 Contractor Work Plan: Reserved.

1.5.5 Training Holidays: Reserved.

1.5.6 Place of Performance: Work will be performed at Phramongkutklao Hospital (PMK) in Thailand where studies and projects are being implemented, in accordance with a schedule developed by the contractor and/or study sponsor(s) as needed to accomplish the deliverables.

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

1.6.1 Security Program: Reserved.

1.6.2 Personnel Security Clearance Requirements: Reserved.

1.6.3 Installation Access: Reserved.

1.6.3.1 Installation Pass Log: Reserved.

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

1.6.4 Background Checks: Reserved.

1.6.4.1 U.S. Citizen: Reserved.

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

1.6.6 Operations Security (OPSEC) Requirements: Reserved.

1.7 Key Control: Reserved.

1.8 Post Award Conference/Periodic Progress Meetings: The Contractor shall attend any post award conference convened by the contracting activity or contract administration office.

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 position(s) have been identified to be filled by Key Personnel proposed for this award.

Key Personnel Position Minimum Requirements Program/Contract

Manager A physician with Thai medical license, experienced in infectious diseases field

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.001).

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.001).

1.11 Identification of Contractor Employees: Reserved.

1.11.1 Contractor Workspace: Reserved.

1.11.2 Contractor Identification Badges: Reserved.

1.12 Contractor Travel: All travel listed in the table below shall be pre-approved by the COR and is on a strictly cost reimbursable basis. The Contractor may be authorized travel expenses at rates no higher than the substantive provisions of the Joint Travel Regulation (JTR), IAW FAR Part 31.205-46, and the limitation of funds specified in this contract. All travel requires Government approval and authorization 30 days prior to scheduled travel (A.002)

Period From To Round Trip (Y/N)

# of Trips # of People # of Days

Base year and all 4 option years

Thailand USA Y 1 1 7

1.13 Other Direct Costs (ODCs): Cost type CLINs under this contract will be invoiced as ODCs. 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.

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.003).

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 Other Direct Costs (ODCs).

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): Reserved

1.18 Phase In /Phase Out Period: Reserved.

1.19 Safety: Reserved.

1.20 Environmental Compliance: Reserved.

1.21 Required Training: Reserved.

1.22 Authorization to Perform Services 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.

http://www.dimoc.mil/resources/limitations/

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.

AE Army in Europe AFRIMS Armed Forces Research Institute of Medical Sciences AOR Area of Responsibility AR Army Regulation CAC Common Access Card CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer’s Representative COTS Commercial-Off-the-Shelf CLIN Contract Line Item Number CRF Case Report Form CRO Clinical Research Organization DA Department of the Army DFARS Defense Federal Acquisition Regulation Supplement DMDC Defense Manpower Data Center DoD Department of Defense EC Ethical Committees FAR Federal Acquisition Regulation FRG Federal Republic of Germany GFP Government Furnished Property HLO High Level Objective HIPAA Health Insurance Portability and Accountability Act of 1996 IA Information Awareness ICF Informed Consent Form ID Identification IGCE Independent Government Cost Estimate IRB Institutional Review Boards IT Information Technology JTR Joint Travel Regulation KO Contracting Officer OCI Organizational Conflict of Interest OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs OPSEC Operations Security PA Property Administrator PII Personally Identifiable Information PIPO Phase In/Phase Out PMK Phramongkutklao Hospital POC Point of Contact PRS Performance Requirements Summary PBSC Performance Based Service Contracting PWS Performance Work Statement QASP Quality Assurance Surveillance Plan

QC Quality Control QCP Quality Control Program RA Requiring Activity USAG United States Army Garrison USAREUR United States Army Europe USAMD United States Army Medical Directorate USAMRDC United States Army Medical Research & Development Command WHO World Health Organization 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: Reserved.

3.8 Common Access Cards (CAC): Reserved.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. Contractor Furnished Property and Services

4.1 General: Reserved.

4.2 Secret Facility Clearance: Reserved.

4.3 Materials: Reserved.

4.4 Vehicles and Equipment: Reserved.

4.5 Background Checks: Reserved.

PART 5

SPECIFIC TASKS

5.1 Basic Services: The contractor shall perform scientific/technical, regulatory, clinical, laboratory, administrative, and logistical tasks to support surveillance and studies related to respiratory viruses. Up to 1500 subjects may be enrolled per year at Phramongkutklao (PMK) hospital. Projects shall be conducted in accordance with the prescribed protocols, current or amended, as may be available and approved by international and local regulatory authorities.

This shall include collaborating on the execution of the protocol with the USAMRDC, local regulatory authorities, USAMD-AFRIMS, and local collaborators, stakeholders, and communities, to include collaborating in interpretation, complication, analysis, presentation, and publishing of study results. In coordination with AFRIMS, the contractor shall submit study-related material to all relevant Ethical Committees (EC) or Institutional Review Boards (IRBs), respond to their queries, and obtain approvals.

5.2 Tasks:

5.2.1 Clinical and Epidemiological Tasks

5.2.1.1 Collaborate with AFRIMS to execute study protocols and submit study-related material, respond to inquiries, and obtain approvals from relevant ECs and IRBs (A.004).

5.2.1.2 Perform subject recruitment and enrollment as well as study intervention. These tasks shall be performed by qualified medical and epidemiological staff (i.e., physicians, nurses, allied health professionals, and others). If applicable, maintain study-related documentation (i.e. informed consent form (ICF), case report form (CRF), and others) and perform clinical and epidemiological evaluations; specimen collection, processing, storage, and shipping; data documentation; and logistical and administrative support as well as other tasks as needed in support of studies. (A.005) Clinical assessments rendered may include vitals sign measurements, physical examinations, adverse event reports and other clinical evaluations as needed.

5.2.1.2 Follow protocols for community engagement, study advertisement, screening and recruitment, clinical management and radiological support, enrollment, demographic/clinical data and sample collection of enrolled subjects (i.e., obtaining informed consent, medical history, performing physical examination, inclusion/exclusion assessment, immunization, follow-up of subjects and completion of case report form, phlebotomy, ultrasound) and initial laboratory testing.

5.2.1.3 Collect, manage, and provide clinical, demographic, and epidemiological data from study subjects as described in the approved protocols, in a format that is required by study-related forms and protocols.

5.2.1.4 Collect, process, and store biological specimens (i.e., blood, respiratory swabs, urine, and others as relevant) collected from enrolled subjects during the execution of a study protocol. Ship biological specimens to AFRIMS for storage and testing and/or to the U.S. for further testing in accordance with approved protocols or as part of USAMD-AFRIMS public health services. Provide local or international transportation including data/supply/specimen shipment in-out of the country, coordinating with participating hospitals, health centers, or study sites and AFRIMS for the specimen collection and transfer, and providing temperature-controlled storage before and during transportation of samples to AFRIMS. (A.006)

5.2.1.5 Conduct laboratory testing. Qualified laboratory and technical staff (i.e., medical research technologists, technicians, microscopists, and laboratory workers) shall conduct laboratory assessments required to support study activity. Assessments rendered may include complete blood counts, chemistries, urine testing, immunological and diagnostic assays, clinical microscopy, and other lab tests as required. (A.007)

5.2.1.6 Collaborate with AFRIMS in the interpretation, complication, analysis, presentation, and publishing of study results. (A.008)

5.2.2 Supplies, Data, and Financial Management

5.2.2.1 Provide and store supplies and reagents needed to support AFRIMS projects related to studies in this PWS and guarantee their delivery as requested by AFRIMS.

5.2.2.2 Provide transportation and communications. Provide transportation for contractor personnel and non-personnel resources, to include ground/physical transportation between PMK and AFRIMS, by whatever conveyance is required to meet project needs. In addition, provide communications services support, to include phone and email services, to meet project needs.

5.2.2.3 Track administrative, accounting, and financial data for inclusion in a financial report consisting of the number of collected samples and details of expenditures to be reimbursed. (A.009)

5.2.2.4 Maintain files and provide storage space for work products (including all clinical protocol associated documents), associated reference material, and data for the duration of the contract.

5.2.3 Project Management, Quality Assurance, and Reporting

5.2.3.1 Establish internal standard procedures to ensure oversight on the proper conduct of the biomedical surveillance and study projects to continually improve and ensure uninterrupted, timely, and efficient conduct of the study by providing the necessary continuous quality assurance systems.

5.2.3.2 Provide a quarterly report describing the study progress, including number of subjects enrolled/withdrawn; problems encountered (regulatory, compliance, financial, logistical, etc.) and status; issues anticipated in future study periods; and study-related event schedule to include site visitations, audits, IRB reviews, etc. The report shall include a spreadsheet with detail of real-time expenditure levels of every contract line item number

(CLIN). The report is due no later than 30 business days after the end of each quarter after the contract is awarded. (A.010)

5.2.4 Meetings and Training

5.2.4.1 Attend the annual face-to-face meeting with AFRIMS Virology. Provide space adequate for meetings or training events which are attended by AFRIMS personnel, or personnel from clinical sites and others. Provide travel related to site visits/meetings, training, conferences, workshop, and presentation in support of this contract.

5.2.4.2 Complete mandatory initial and annual refresher training for personnel involved in the studies in order to implement studies to ensure compliance with required institutional class or on-line trainings and other trainings required by AFRIMS, the sponsor, or assigned Clinical Research Organization (CRO).

5.3 Service Contract Reporting: Reserved.

PART 6

APPLICABLE PUBLICATIONS

6. Applicable Publications (Current Editions): The following publications, manuals, regulations, etc. are mentioned in this PWS and are listed below.

6.1.1 Department Of Defense Contract Security Classification Specification (DD Form 254)

6.1.2 Department of Defense Security Agreement (DD Form 441)

6.1.3 National Industrial Security Program Operating Manual (DoD 5220.22-M)

6.1.4 Installation Access Control (AE Reg 190-16)

6.1.5 The Army Physical Security Program (AR 190-13)

6.1.6 Contractor Identification (AE Reg 27-715)

6.1.7 U.S. Army Corps of Engineers Safety and Health Requirements Manual (EM 385-1-1)

6.1.8 Information Assurance Workforce Improvement Program (DoD 8570-M)

6.1.9 Information Assurance Training Certification and Workforce Management Directive (DoDD 8570.01)

6.1.10 Information Assurance (AR 25-2)

6.1.11 Electromagnetic Compatibility Directive (2004/108/EC)

6.1.12 Policies and Procedures for Property Accountability (AR 735-5)

PART 7

ATTACHMENT AND TECHNICAL EXHIBIT LISTING

7. Attachment and Technical Exhibit List

7.1 Technical Exhibit A – Performance Requirements Summary

7.2 Technical Exhibit B – Deliverables Schedule

TECHNICAL EXHIBIT A

Performance Requirements Summary (PRS)

PERFORMANCE

OBJECTIVE

STANDARD PERFORMANCE

THRESHOLD

ACCEPTABLE

QUALITY

LEVELS (AQLs)

METHOD OF

SURVEILLANCE

PRS#1 – PWS para (5.2.1)

The Contractor shall exhibit good research practices

Projects shall be conducted in accordance with the prescribed protocols, current or amended as may be available and approved by international and local regulatory authorities.

100% operational accuracy -Any deviations from the protocols will be handled in compliance with international and local regulations.

Direct observation and analysis of Contractor reports.

PRS#2 – PWS para (5.2.2, 5.2.3, 5.2.4)

The contractor shall meet deliverable deadlines

The contractor shall provide on time, accurate deliverables.

99% - Any deviations from the protocols will be handled in compliance with international and local regulations

Direct observation and analysis of Contractor reports.

TECHNICAL EXHIBIT B

DELIVERABLES SCHEDULE

Deliverable Frequency # of Copies Medium/Format Submit To A.001

Key Personnel Resumes and Program/Cont ract Manager and Alternate CVs

(Para 1.10)

CVs for Program/Contract Manager as well as Alternate due with 5 days of award

Key personnel resumes due two weeks (or mutually agreed upon) prior to personnel change

1 Electronic document (MS Word, MS Excel, or PDF)

COR

A.002

Travel Estimate and Trip Reports

(Para 1.12)

Travel Estimates due 30 calendar days prior to scheduled travel

Trip Reports due 10 days after completion of travel

1 Electronic document (MS Word, MS Excel, or PDF)

COR

A.003

Invoices

(Para 1.13.1)

Monthly 1 Electronic document (MS Word, MS Excel, or PDF)

WAWF

A.004

IRB and EC Approvals

(Para 5.2.1.1)

As requested 1 Electronic document (MS Word, Excel, or

PDF)

COR

A.005

Data, Clinical and Demographic

(Para 5.2.1.2, 5.2.1.3, 5.2.1.5)

Monthly N/A In format required by study-related forms and protocols

COR

A.006

Biological Specimens

Ship within 48 hours from collection

N/A Appropriate medium for specimens

Deliverable Frequency # of Copies Medium/Format Submit To (Para 5.2.1.4)

A.007 Laboratory testing

(para 5.2.1.5)

As required by study protocol

1 As requested or appropriate for the presentation or publication of study results

COR

A.008

Study Results

(Para 5.2.1.6)

As requested 1 As requested or appropriate for the presentation or publication of study results

COR

A.009 Financial Report

(Para 5.2.2.4)

Upon invoice submission 1 Electronic via WAWF/Email

A.010

Performance Report

(Para 5.2.3.2)

Quarterly (No later than 30 business days after end of each quarter)

1 Electronic via email