A02-PWS PANMRA-24-P-0000 004077 Clinical and Surveillance Studies.pdf

PERFORMANCE WORK STATEMENT (PWS)

Biomedical, Clinical, and Surveillance Studies for Clinical Trials Related to Respiratory and Vector-Borne Diseases in Southern Thailand Recompete 19P0153

26 April 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 biomedical research.

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 Walter Reed Army Institute of Research - Armed Forces Research Institute of Medical Sciences (WRAIR-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 for the conduct of epidemiological, clinical, and laboratory activities related to biomedical research and surveillance projects to take place within Southern Thailand.

Some parts of Southern Thailand are a US-personnel restricted area and epidemiological information from Southern Thailand has considerable gaps. This region is of significant interest due to its location, and the proximity and cross border traffic with Malaysia. Most of Southern Thailand is rural with many of the inhabitants outside the city center, working in the agricultural field and continuously exposed to mosquito vectors.

1.3 Scope: The contractor shall perform services including (but not limited to) 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 for respiratory and vector-borne disease epidemiology and clinical trials. This requirement is based on WRAIR / WRAIR-AFRIMS current mission, as the mission changes, the needs may increase or decrease.

1.3.1 Period of Performance

Base Period 23 September 2024 – 23 September 2025 Option Period 1 23 September 2025 – 23 September 2026 Option Period 2 23 September 2026 – 23 September 2027 Option Period 3 23 September 2027 – 23 September 2028 Option Period 4 23 September 2028 – 23 September 2029

1.4 Objective: To provide non-personal services associated with scientific/technical, regulatory, epidemiological, clinical, laboratory, administrative, database management, quality assurance and logistical support required by biomedical, clinical, and surveillance studies being conducted in Southern Thailand.

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 30 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 Holidays listed below.

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: The Contractor shall follow their own institution work schedules to achieve the objectives. The Contractor shall maintain an adequate workforce at all times, for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall ensure 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 Prince of Songkla University, Songkhla, Thailand or public health facilities or community in accordance with study protocols.

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:

(1) The following positions have been identified to be filled by Key Personnel proposed for this award.

Key Personnel Position Minimum Requirements Program/Contract Manager Licensed local physician

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.

1.12 Contractor Identification Badges. Reserved.

1.13 Contractor Travel:

All travel local (one to two trips from Songkhla to Bangkok or third location within Thailand) or international (one to two trips for international travel possibly in the U.S.) shall be pre-approved by the COR, is on a strictly cost reimbursable basis, and shall 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

Songkhla Bangkok Y 2 1 3

Base year and all 4 option years

Songkhla USA Y 1 2 7

1.14 Other Direct Costs (ODCs): ODCs are anticipated in the performance of work in this contract and may include travel, supplies, materials, printing and 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 attach back up information to receiving reports for direct labor and ODCs.

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

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 $10,000 requires the contractor to conduct appropriate competition and obtain approval from the KO prior to purchase. 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.

1.15 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.

1.16 Non-Disclosure Requirements: Performance under this contract may require the Contractor to access data and information proprietary to a Government agency, another Government Contractor, or of such nature that its dissemination or use other than as specified in this work statement would be adverse to the interests of the Government or others. The Contractor and Contractor personnel, shall not divulge or release data or information developed, or obtained under performance of this PWS, except to authorized Government personnel or upon written approval of the 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.

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

1.18 Non-Disclosure Statements: Reserved.

1.19 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 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.006).

1.20 Phase In /Phase Out Period: Reserved.

1.21 Safety: Reserved.

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

1.22 Environmental Compliance: Reserved.

1.22.1 Environmental Compliance Plan and Program: Reserved.

1.23 Required Training: Reserve .

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

1.23.2 OPSEC Training: Reserved.

1.23.3 iWATCH Training: Reserved.

1.23.4 Information Assurance (IA) Training. Reserved.

1.23.5 Personally Identifiable Information (PII): Reserved.

1.24 Authorization to Perform Services in Thailand

1.24.1 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.

1.24.2 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.

1.24.3 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.

1.25 Notice to Proceed: Reserved.

1.26 Electromagnetic Compatibility Directive: Reserved.

1.27 Government Property and Services: Reserved.

1.28 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 Event AE Army in Europe AFARS Army Federal Acquisition Regulation Supplement AFRIMS Armed Forces Research Institute of Medical Sciences AHA Activity Hazard Analysis AOR Area of Responsibility AR Army Regulation AT Anti-terrorism ATCTS Army Training Certification Tracking System CAC Common Access Card CCE Contracting Center of Excellence CFE Conventional Forces Europe CFR Code of Federal Regulations CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer’s Representative COTS Commercial-Off-the-Shelf 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 DMDC Defense Manpower Data Center DoD Department of Defense EC Ethical Committee 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 IAC Installation Access Control IACO Installation Access Control Office ID Identification IGCE Independent Government Cost Estimate IRB Institutional Review Board IT Information Technology JTR Joint Travel Regulation JPAS Joint Personnel Adjudication System 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 PI Principal Investigator PII Personally Identifiable Information PIPO Phase In/Phase Out POC Point of Contact PRS Performance Requirements Summary PSU Prince of Songkla University 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 RCO Regional Contracting Office SAE Serious Adverse Events SIGE Safety and Health Protection Plan SOP Standard Operating Procedures TE Technical Exhibit USAG United States Army Garrison USAREUR United States Army Europe UOM Unit of Measure USAMD United States Army Medical Directorate 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: Contractors shall conduct all work at the existing contractor hospital and university locations.

4.2 Secret Facility Clearance: Reserved.

4.3 Materials: Reserved.

4.4 Vehicles and Equipment: Reserved.

4.5 Background Checks: Reserved.

PART 5

SPECIFIC TASKS

5.1 Basic Services: The contractor shall provide services associated with scientific/technical, regulatory, epidemiological, clinical, laboratory, administrative, database management, quality assurance, and logistical support to the respiratory and vector-borne disease epidemiology and clinical trials.

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 the WRAIR/AFRIMS Department of Virology contact and/or the COR for any issues.

5.2.1.2 Assist with procurement, reimbursement, and travel and meeting logistics required to perform the work in this PWS.

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

5.2.1.4 Provide annual performance reports. (A.008) 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 anticipated in future option periods.

5.2.1.5 Provide quarterly study performance reports. The Contractor shall provide a report describing details of real-time expenditure levels of the ODC contract line-item number (CLIN), training reports, study progress, problems encountered and status, issues anticipated in future study periods, and a study-related event schedule to include site visitation, audits, IRB reviews, etc. (A.009)

5.2.2 Surveillance Task Area. The contractor shall support to AFRIMS in the execution of surveillance studies. The contractor shall provide services associated with the execution of such studies, as outlined in related protocol(s). The contractor shall:

5.2.2.1 Provide the required principal investigator (PI) and clinical support staff, including clinical researchers, nurses, laboratory technicians, and quality control/quality assurance staff.

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

5.2.2.3 Provide support for subject recruitment, enrollment, active follow-up, interviewing, maintenance of study-related documentation, and periodical clinical examination of subjects.

5.2.2.4 Collect and transfer biological specimens and data (clinical and demographic). A maximum of 1800 blood samples (including acute and convalescent) for febrile visits and a maximum 600 respiratory samples shall be collected, processed, stored, and transferred to

AFRIMS. (A.010, A.011)

5.2.2.5 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. (A.012)

5.2.2.6 Maintain the existing database of files accessible and reportable to the Government and Government designees upon notification from the COR relevant to the projects.

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

5.2.2.8 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 clinical research organization (CRO).

(A.013)

5.2.2.9 Assist with study document translations.

5.2.2.10 In coordination with AFRIMS, submit all study-related material to all relevant local Ethical Committees (EC) or IRB and respond to their queries and obtain approvals. (A.014)

5.2.3 Epidemiological Task Area. The contractor shall support AFRIMS in the execution of prospective arboviral epidemiology studies, particularly related to chikungunya virus. 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 PI and clinical support staff, including clinical researchers, nurses, and laboratory technicians at Songklanagarind Hospital for the execution of arboviral epidemiological studies that enroll and perform blood draw for up to 1500 subjects in Southern Thailand per study.

5.2.3.2 Provide active surveillance of up to 1500 subjects and collect samples and data from all acute and corresponding convalescent samples.

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

5.2.3.4 Provide support for subject recruitment, enrollment, active follow-up, interviewing,

5.2.3.4 Collect biological specimens such as blood, respiratory swabs, urine, or other specimens as determined by the study. Collect data such as epidemiological, clinical, laboratory, or other data as relevant for the study, and periodically process, store, and transfer specimens and data per IRB-approved protocols to AFRIMS. (A.010, A.011)

5.2.3.5 Maintain electronic and hardcopy files for work products including all clinical contract. (A.012)

5.2.3.6 Maintain the existing database (or catalogue) of files accessible and reportable to the Government and Government designees upon notification from the COR relevant to the projects.

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

5.2.3.8 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.013)

5.2.3.9 Assist with study document translations.

5.2.3.10 In coordination with AFRIMS, submit study-related material to all relevant local EC or IRB, respond to their queries, and obtain approvals. (A.014)

5.2.4 Clinical Trial Support Task Area. The contractor shall support AFRIMS in the execution of arboviral (particularly chikungunya) clinical and investigational trial studies. The Contractor shall provide services associated with the execution of interventional studies, as outlined in related protocol(s). Contractor shall:

5.2.4.1 Provide the required PI and clinical support staff, including clinical researchers, pharmacists, nurses, and laboratory technicians at Songklanagraind Hospital for the execution of arboviral epidemiological studies that enroll and follow up to 2,048 subjects in Southern Thailand per study.

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 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 for subject recruitment, enrollment, active follow-up, interviewing,

5.2.4.6 Collect biological specimens such as blood, respiratory swabs, urine, or others specimens determined by the study. Collect data such as epidemiological, clinical, laboratory, or other data as required, and periodically process, store, and transfer specimens to AFRIMS.

(A.010, A.011)

5.2.4.7 Maintain electronic and hardcopy files for work products including all clinical contract. (A.012)

5.2.4.8 Assist with maintaining 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 and call reimbursement to subjects as approved by the IRB.

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.013)

5.2.4.11 Assist with study document translations.

5.2.4.12 Provide administrative management, reporting, and clinical care and treatment, and, where appropriate, 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).

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 s. Areas for specimen collection and/or investigational products shall conform to safety and storage guidelines appropriate for the area.

5.3 Service Contract Reporting

5.3.1 System for Award Management (SAM) Service Contract Report (SCR): The Contractor shall report ALL Contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the WRAIR via a secure data collection site. The Contractor is required to completely fill in all required data fields through the following web address: www.sam.gov. Reporting inputs will be for the labor executed during the period of performance during each Government FY, which runs from October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year. Contractors may direct questions to the help desk by clicking “View Assistance for SAM.gov” which is located at the top of the SAM.gov website. From there, you can the select “Contact Our Service Desk” which will allow you to contact SAM.gov directly. If contract period of performance ends prior to http://www.sam.gov/

September 30, the Contractor has 30 calendar days from end date of the contract to complete the SAM SCR requirement (A.015)

Steps for Submitting a Service Contract Report (SCR)

1. Go to www.sam.gov and log in.

2. Select Entity Registrations and then select Service Contract Reporting.

3. SAM displays your entities which have service contracts and meet the reporting criteria.

Select View by entity to see the service contracts for each entity.

4. Next, select Add for the service contract against which you want to create a Service

Contract Report. Each service contract which meets the FAR Subpart 4.1703 reporting thresholds is displayed.

5. You will be taken to the Complete Service Contract Report page. SAM displays the contract details and allows you to report. You are required to enter the following information:

• Total Amount Invoiced: Total dollar amount invoiced for services performed during the previous Government fiscal year under the contract (this amount should include the prime and any subcontract amount).

• Prime Contractor Hours Expended: Prime contractor direct labor hours expended on the services performed during the previous Government fiscal year. The amount you enter is automatically divided by 2,080 hours to calculate a Full Time Employee (FTE) equivalent, displayed under the Prime Contractor Hours Expended as Prime Contractor FTEs.

6. Report any required Tier 1 subcontractor information by selecting the Add Tier 1 Subcontract Information button.

7. When you are ready to submit the report, select Submit. This saves your report and returns you to the Select Service Contract page where you can create other SCRs or edit an existing SCR.

Steps for Editing a Submitted Report

1. Follow steps 1-4 above. Any previously submitted SCR will have a View/Edit button instead of an Add button.

2. Select View/Edit. You will be able to view the current SCR, edit available fields, and resubmit the record. You can also delete previously entered information altogether.

STD: All information provided by the Contractor shall be accurate, complete, and not exceed suspense dates noted in corresponding paragraph above.

AQL: 100% Compliant http://www.sam.gov/

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 (5.2.2; 5.2.3; 5.2.4)

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 (5.2.1.1, Technical Exhibit B)

The contractor shall meet deliverable deadlines

The contractor shall provide accurate, on-time deliverables

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

Date deliverables are provided.

TECHNICAL EXHIBIT B

DELIVERABLES SCHEDULE

Deliverable Frequency # of Copies Medium/Format Submit To

A.001

QCP

(Para 1.5.1)

Draft QCP due within 30 days of award; final QCP due within 30 days of receipt of Government comments.

Proposed changes due NLT 30 days prior to anticipated change and implementation

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

(SAFE)

POC at

AFRIMS

A.002

Analysis of Quality Control and Timeliness of Submittals

(Para 1.5.1.1)

Due within 30 days upon completion of each option period or Task Order

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

COR

A.003

Performance Issues or Potential Issues Report

(Para 1.5.1.2)

Verbal report due within 48 hours of identifying potential issues; written report due within 2 days thereafter

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

COR

A.004

Key Personnel Resumes and Program/Contract Manager and Alternate CVs

(Para 1.10)

CVs for Program/Contract Manager as well as Alternate due within 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.005

Travel Estimates due 30 calendar

1 Electronic document (MS

COR

Copies Medium/Format Submit To

Travel Estimate and Trip Reports

(Para 1.13.1) days prior to scheduled travel

Trip Reports due 10 days after completion of travel

Word, MS Excel, or PDF)

A.006

OCI Mitigation Plan

(Para 1.19)

Due immediately when Contractor becomes aware that such access or participation may result in an actual or potential OCI

1 Electronic document (MS Word, Excel, or

PDF)

COR

A.007

Invoice Submission Documentation

(Para 5.2.1.3)

Monthly (No later than 7 business days after end of each month)

1 Electronic Document

POC at

KAVRU/

A.008

Annual Performance Report

(Para 5.2.1.4)

Annually no later than 30 days prior to contract option year end date

1 Electronic document

COR

A.009

Financial Report

(Para 5.2.1.5)

Quarterly 1 Electronic document

A.010

Specimen and Data Collection Report

(Para 5.2.2.4, 5.2.3.4, 5.2.4.6)

Monthly; no later than 7 business days after end of each month

1 Electronic document

A.011

Shipment of Samples

(para 5.2.2.4, 5.2.3.4, 5.2.4.6)

Within 30 days of sample collection

1 Electronic document

Copies Medium/Format Submit To

A.012

Electronic and Hardcopy Database

(Para 5.2.2.5, 5.2.3.5, 5.2.4.7)

Maintain as required by study

1 Electronic document

COR

A.013

Training Requirements

(para 5.2.2.8, 5.2.3.8, 5.2.4.10)

Annually or can be included with monthly report

1 Electronic document

POC at

AFRIMS

A.014

Ethical Committee and Institutional Review Board Queries

(para 5.2.2.10, 5.2.3.10, 5.2.4.8)

As required by

AFRIMS

1 Electronic document

POC at

AFRIMS

A.015

SCR

(Para 5.3)

NLT 31 October each calendar year and within 30 calendar days from the end date of the contract

1 Electronic document (MS Word or Excel &

PDF)

www.sam.go v