Attachment 1 PWS - IDS in Laos final.docx

PERFORMANCE WORK STATEMENT (PWS)

Infectious Disease Surveillance and Research in Laos 13 June 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 Armed Forces Research Institute of Medical Sciences (AFRIMS) support to conduct research projects in the Laos People's Democratic Republic for surveillance projects which study the pathogen and vector resistance to malarial drugs, antimicrobials, insecticides and bacteria with antimicrobial resistance. Other research projects on respiratory, febrile, and bacterial infections may be needed as disease threats change.

1.2 Background: The mission of the Walter Reed Army Institute of Research (WRAIR) and its subordinate organization 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).

AFRIMS seeks to initiate and continue ongoing research projects involving surveillance for emerging infectious diseases and conduct clinical trials within Laos with a specific focus on malarial prevalence and antimalarial drug resistance together within the ranks of the Lao People’s Armed Forces (LPAF). AFRIMS currently conducts insecticide efficacy trials through approval by the Ministry of National Defense (MoND). AFRIMS will expand research and infectious disease surveillance projects with a primary focus on malaria, but not limited to malaria, with the Ministry of National Defense and the Ministry of Public Health (MoPH).

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:

The period of performance shall be as follows:

1.4 Objectives: The objective of this contract is to provide services and expertise to conduct medical research and surveillance for AFRIMS’ projects within Laos. This support shall include field advertisement, the site rental space for subject enrollment, subject compensation, sample collection, sample processing, point-of-care and preliminary lab testing, moderate to complex lab testing, pathogen identification, sample storage, and transporting of the samples to AFRIMS or another lab to conduct more advanced laboratory testing. Surveillance and research shall be on malaria prevalence and antimalarial drug resistance, bacteria with antimicrobial resistance, sexually transmitted pathogens, respiratory viral pathogens, bacterial pathogens, agents of parasitic disease and other emerging infections found in the LPAF ranks and in the Laos citizens. Products that may be evaluated in clinical trials include anti-malarial drugs and/or vaccines, anti-viral drugs, anti-microbial drugs, other potential candidates with activity against infectious disease agents as well as diagnostic tests. The contractor shall provide office space, utilities, as well as security per local regulations.

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 ten days after date of contract award (Deliverable 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 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 IAW 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 workday prior to the holiday will apply as the deadline for submittal.

1.5.3.1 U.S. Holidays: Reserved.

1.5.3.1 Host Nation Holidays: Work shall not be performed on local Host Nation holidays occurring during the normal workweek unless otherwise directed by the KO.

April 13 to 15 - New Year's Day (Pi Mai Lao) May 1 - International Labour Day Usually in May (based on the lunar calendar) - Visakha Bucha Day December 2 - Lao National Day Usually in November (based on the lunar calendar) - Boun That Luang (That Luang Festival) October 12 - Lao Issara Day Usually in October (based on the lunar calendar) - Boun Ok Phansa (End of Buddhist Lent) Usually in July (based on the lunar calendar) - Boun That Khao (Khao Phansa Day) April 13 to 15 - Boun Pi Mai (Lao New Year)

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 provide support between the hours of 0800 to 1600, Monday through Friday. The facility is closed during local or national emergencies, administrative closings, or similar Government directed facility closings. 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 keep in mind that the stability and continuity of the workforce is essential.

1.5.4.4 Contractor Work Plan: Reserved.

1.5.5 Training Holidays: Reserved.

1.6 Place of Performance: The work to be performed under this contract shall take place within Laos at the People’s Democratic Republic of Laos government sites including the ministry of health and military hospitals and laboratories.

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:

1.7.4.1 U.S. Citizen: Contractors that work with or teach youth under the age of 18 years are subject to U.S. and host nation background checks. The Requiring Activity Manager will determine the extent of background checks required. The Contractor employee may begin performance of the contract after receiving a favorable local background check. The Contractor agrees to replace the employee should results of the background check, if required, be unfavorable as determined by the Requiring Activity Manager. The Contractor’s replacement of the employee with the unfavorable background check shall be within a timeframe provided by the Requiring Activity Manager. The Contractor shall also replace employees whose background check, during their tenure of employment, renders them with an unfavorable local or stateside background check, as determined by the Requiring Activity Manager. The Contractor shall forward a copy to the KO via the COR and the Requiring Activity Manager of each favorable and or unfavorable background check within 30 days of receipt by the Contractor, identifying such with the appropriate contract number. When the Government awards a non-personal services contract directly to an individual, the failure of the individual to provide a favorable background check would be grounds for termination (A.004).

1.7.4.2 Local Nationals and Third Country Nationals: Reserved.

1.7.5 Physical Security: The Contractor shall safeguard all Government equipment, information, and property provided for Contractor use. At the close of each work period, Government facilities, equipment, and materials shall be secured IAW the Army Physical Security Program AR 190-13.

1.7.6 Operations Security (OPSEC) Requirements: Contractor personnel shall adhere to facility security policies and restrictions. The Contractor shall immediately report suspicious activities to security personnel.

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 in accordance with FAR Subpart 42.5. The KO, COR, and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings the KO 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 managerial, supervisory, 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 KO, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the Contractor by the KO. 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 KO and Contractor of any deficiencies, coordinate availability of Government property, and coordinate site entry of Contractor personnel.

1.10 Key Personnel:

Demonstrated relationships with clinical sites including Lao’s Peoples Armed Forces facilities and facilities associated with the Ministry of Health A professional medical or doctorate of philosophy degree Demonstrated training in human subject protections during a research Demonstrated expertise in at least one infectious disease including: entomology, bacteriology, virology, parasitology, or mycology

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.005).

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.005).

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: The Contractor may be required to travel within the country of Laos during the performance of this contract to visit sites, conduct training, collect samples, develop plans, and discuss findings. 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.007).

1.13 Other Direct Costs (ODCs): This category includes travel (outlined in 1.12), study subject compensation and supplies, printing and shipping expenses associated with training activities, and visits to Contractor facilities. 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.

ODC Plug Numbers

Period 1 Option Period 2

Travel/Subject Compensation/ Supplies

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.008).

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 KO. 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 KO. 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: The Contractor shall provide signed non-disclosure agreements to the Government no later than 30 days prior to commencement of work under the contract. Disclosure of information by Contractor personnel may result in removal of Contractor personnel from performance under this contract (A.009).

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 Contractor shall notify the KO 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 KO 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 KO. In the event the KO unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the KO 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.010).

1.18 Phase In /Phase Out Period: Reserved.

1.19 Safety: The following provides information pertaining to Safety and Accident Prevention:

1.19.1 Host Nation Safety Laws and Regulations: The Contractor shall comply with FAR 52.236-13, Accident Prevention (November 1991), the references contained therein (e.g., U.S. Army Corps of Engineers Safety and Health Requirements Manual (EM 385-1-1)).

The requirements under FAR 52.236-13 and specifically of the EM 385-1-1 include, but are not limited to the following:

(a) Before initiation of work at the job site, an Accident Prevention Plan, written by the Contractor for the specific work and hazards of the contract and implementing in detail the pertinent requirements of EM 385-1-1; will be reviewed for acceptance by designated Government personnel. Specific requirements for development of the Accident Prevention Plan are found in 01.A and Appendix A of EM 385-1-1. EM 385-1-1 is available online at www.usace.army.mil (A.011).

(b) Before beginning each activity involving a type of work presenting hazards not experienced in previous project operations or where a new work crew or subcontractor is to perform work, activity hazard analysis (AHA) shall be prepared by the Contractor performing the work activity (See paragraph 01.a.09 of EM 385-1-1);

(c) The Contractor shall require subcontractors to submit their plan of operations showing methods they propose to use in accomplishing major phases of work;

(d) The Contractor shall discuss the plans in conferences convened by the KO prior to starting work on each major phase of operation. Plans shall include all pertinent information such as selection of clinical sites, regulatory approval plans, testing strategies, and reporting formats . Plans for subsequent major phases of work shall be submitted no later than fifteen (15) calendar days prior to initiation of work on each major phase; and

(e) In all areas where lab and healthcare activities occur, the Contractor shall have the following minimum personal protective clothing and equipment requirements in place for any person working on or visiting the site: lab coat, long trousers, and latex gloves.

1.19.2 In addition to other requirements for accident prevention specified in this contract, the Contractor shall comply with all Federal and State requirements governing safety and health protection on construction sites and other applicable occupational safety codes.

The Contractor shall indicate its plan for compliance considering conditions of the work described by the design, technical proposal, operational activities of the Government or others in the area of the work, identification of the coordinator, and implementation of all other accident prevention provisions of this contract.

1.19.3 The Contractor shall complete and provide safety notifications required by host nation authorities and will provide documented proof to the KO via the COR, no later than 30 days that such notifications were made (A.011).

1.20 Environmental Compliance: The following provides information on Environmental Compliance.

1.20.1 Environmental Compliance Plan and Program: Reserved.

1.21 Required Training: The following provides information on training requirements.

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

1.21.2 OPSEC Training: Reserved.

1.21.3 iWATCH Reserved.

1.21.4 Information Assurance (IA) Training Reserved.

1.21.5 Personally Identifiable Information (PII): Reserved.

1.22 Authorization to Perform Services in Laos.

1.22.1 Contractors performing services in Laos shall comply with the laws of Laos. The Contractor shall determine whether performance requires registration with the Laos authorities or authorization to do business in Laos 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 Laos. 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 Laos; 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 the laws of Laos 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: Refer to Part 3 of this PWS for Government property (GP) for this contract. For all issued GP for this contract, the Contractor shall submit a Property Management Plan to the KO and the Property Administrator via the COR within 30 days after date of contract award.

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 KO 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, KO’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 KO 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 KO appointed in accordance with agency procedures, responsible for administering the contract requirements and obligations relating to Government property in the possession of a Contractor.

High Level Objective (HLO) – means a key overarching result-based objective for a project necessary to achieve the project’s vision. HLOs are similar to Level 2 in a Work Breakdown Structure. Each HLO may contain several statements to flesh out the areas necessary to meet the objective.

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.

Statement – means the specific results-based activities required to satisfy HLOs. A statement contains a result, the context of the statement, and the required action(s). Statements focus on “what” is to be accomplished; however they are not prescriptive in describing “how” the outcome is to be achieved. Each HLO may have several statements to flesh out the areas necessary to meet the objective. Statements are similar to Level 3 in a Work Breakdown Structure.

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.

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: The contractor shall provide office space, utilities, as well as security per local regulations.

4.2 Secret Facility Clearance: Not Applicable

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: Not Applicable

4.5 Background Checks: Background checks may be required as stated under section 1.7.4.1.

PART 5

SPECIFIC TASKS

The Contractor shall provide support services for the surveillance of the malaria and antimicrobial resistant bacteria in Laos. This support shall include field advertisement, the site rental space for subject enrollment, subject compensation, sample collection, sample processing, point-of-care and preliminary lab testing, moderate to complex lab testing, pathogen identification, sample storage, and transporting of the samples to AFRIMS or another lab to conduct more advanced laboratory testing. Surveillance and research shall be on malaria prevalence and antimalarial drug resistance, bacteria with antimicrobial resistance, sexually transmitted pathogens, respiratory viral pathogens, bacterial pathogens, agents of parasitic disease and other emerging infections found in the LPAF ranks and in the Laos citizens.

5.1 Basic Services:

The Contractor shall apply the principles of Good Clinical Practice (GCP) in all aspects of the studies, meeting quality and management standards to ensure clinical trial and infectious disease surveillance projects are conducted with integrity, accuracy, and completeness. The Contractor shall coordinate with AFRIMS and the study teams in the execution of the projects, to include: organization and personnel, facilities, patient enrollment, maintaining adequate supply of materials and reagents, standard operating procedures in sample management encompassing sample collection, transport and chain of custody, sample storage/retention of samples, proper record keeping/reporting, as well as ensuring reports are available for quality control/quality audits.

5.2 Tasks: Surveillance Support Services consist of the following:

5.2.1 Protocol Compliance. The Contractor shall contribute to the writing and adherence to a human subjects protection protocol. This shall include the following:

(a) Provide at least one team member to ensure that all team members follow the respective human subjects protocol that directs the infectious disease surveillance and research in the Lao People’s Democratic Republic (PDR) with the Laos People’s defense forces and the Ministry of Health

(b) Coordinate with the local human subjects review office within Laos to meet the required documentation for research approval

(c) Meet any documentation requirements for the protocol including assisting AFRIMS with the annual continuing review and reporting any deviations, unexpected, or serious adverse events (A.012)

5.2.1.1 Malaria prevalence and antimalarial drug susceptibility subject Enrollment Support. The Contractor shall provide support for at least 75 subject enrollments, to include the following:

(a) Advertise and socially communicate the research aim, scope, and community advantages for a subject to participate in the study.

(b) Identify potentially eligible subjects residing, working, or visiting within Laos, using study inclusion criteria which includes:

a. Lao people, male or female, aged ≥ 7 years old, civilian and military

b. Having asexual parasitemia of Plasmodium spp. detected by blood smear or Rapid Diagnostic Test (RDT) depending on available methods at each study site

c. Willing to participate in the study as evidenced by signing informed consent form (written or thumb printed)

(c) Generate subject identification code list by assigning each subject a unique identification code which includes the study number, the study site code/name, and a unique number for the subject in sequential order of enrollment.

(d) Obtain written informed consent forms from participants by presenting the forms to the potential enrollees, requesting their voluntary consent, and retaining the signed consent form (A.013).

5.2.2.2 Subject Compensation Support. The Contractor shall distribute compensation to the participants who comply with all study inclusion criteria.

5.2.2.3 Sample Collection Support. The Contractor shall provide sample collection support, to include the following:

(a) Support sample collection and storage from study participants using venipuncture and aliquoting the sample into appropriate Ethylenediaminetetraacetic acid (EDTA) for blood smear, Polymerase Chain Reaction (PCR), and Ribonucleic Acid (RNA) assays and in lithium heparin for culture-based malaria drug sensitivity tests.

(b) Store samples on microscope slides for microscopy, at -20’C for glucose-6-phosphate dehydrogenase (G6PD) and Complete Blood Count (CBC) testing and cryopreserved for into 96-well plates for drug sensitivity testing. Remaining aliquots should be stored at both -20’C and -70’C.

(c) Ship/deliver these samples to AFRIMS following appropriate custom clearance and transport regulations as well as maintaining appropriate temperatures for the samples throughout the shipping process (A.014).

5.2.2.4 Sample Testing. The Contractor shall perform sample testing, to include the following.

(a) Perform point-of-care, low complexity tests including, microscopy, rapid diagnostic tests, hematology labs, G6PD assay, Gametocytemia, PCR for identification, culture-based and drug sensitivity, and Cytochrome P450 (CYP450) genotype assays.

(b) Maintain reliable records of all testing results and submit detailed reports as requested by the AFRIMS Principal Investigators (A.015).

5.2.2 Antimicrobial resistant Bacteria surveillance

5.2.2.1 Clinical Isolate collection at Clinical Sites

(a) Using standard clinical laboratory microbiology methods identify at least 250 bacterial clinical isolates per year that are suspected to be multi-drug resistant based on the definition in:

a. Magiorakos AP, Srinivasan A, Carey RB, Carmeli Y, Falagas ME, Giske CG, Harbarth S, Hindler JF, Kahlmeter G, Olsson-Liljequist B, Paterson DL, Rice LB, Stelling J, Struelens MJ, Vatopoulos A, Weber JT, Monnet DL. Multidrug-resistant, extensively drug-resistant and pandrug-resistant bacteria: an international expert proposal for interim standard definitions for acquired resistance. Clin Microbiol Infect. 2012 Mar;18(3):268-81

(b) Prepare in glycerol or equivalent preservative and ship isolates to a centralized reference laboratory in Laos

5.2.2.2 Clinical isolate screening at reference lab

(a) Using good laboratory practices, confirm at least 200 of the isolates to meet the definition of multi-drug resistance

(b) Prepare in glycerol or equivalent preservative and Ship confirmed isolates to AFRIMS

5.2.4 Required Reporting. The Contractor shall report protocol deviations to the WRAIR Institutional Review Board (IRB) and appropriate local authorities (A.016). A deviation is defined as follows: a significant deviation occurs when there is non-adherence to the IRB approved protocol that has the potential to affect the rights and welfare of the research participant, to increase the risk to the research participant, to change the willingness of the research participant to continue participation, or to compromise the integrity of the study data in such a way that the study objectives cannot be achieved.

5.2.5 Research Site. The Contractor shall provide management support for the use of physical sites for biomedical research such as clinics, health centers, laboratories, office space, and/or hospitals that are required in order to support to the scientific requirements of the research project. Infrastructure costs may include site rental, utilities, and maintaining the facility as necessary to meet regulatory requirements (A.017).

5.3 OPTION SURGE CLINS: The infectious disease surveillance and research support services for this requirement are based on current mission needs for malaria surveillance. The potential exists that additional projects within the hospital network in Laos will evolve due to increased needs of the U.S. Military through AFRIMS to conduct surveillance or clinical research on a variety of pathogens which cause infectious diseases. The tasks in 5.2.1 through 5.2.5 are representative of the tasks needed to support these optional requirements, although minor adjustments may be needed to conduct a surveillance or clinical research project of other pathogens, or different populations other than the LPDF such as the Laos citizens. These requirements will be coordinated as they become necessary and will be executed in the Optional Surge CLINs as:

(a) A small project with an effort equivalent to 15% of the effort in the main tasks of this PWS

(b) A medium project with an effort equivalent to 30% of the effort in the main tasks of this PWS

(c) A large project with an effort equivalent to 45% of the effort in the main tasks of this PWS

5.4 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.

6.1.14 Protection of Human Subjects and Adherence to Ethical Standards in DoD-Conducted and Supported Research (DoDI 3216)

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

7.3 Attachment 1 – Estimated Workload Data- Not Applicable

7.4 Attachment 2 – Historical Workload Data- Not Applicable

7.5 Attachment 3 – Government Property (GP)- Not Applicable

TECHNICAL EXHIBIT A

Performance Requirements Summary (PRS)

PRS#1 - PWS para 5.2.2 Identify potentially eligible subjects residing, working, or visiting within Laos, using study inclusion criteria

99%

PRS#2 - PWS para 5.2.5 Identify best possible shipping methods and ship/deliver these samples to AFRIMS

99%

PRS#3 - PWS para 5.2.6 Conduct laboratory procedures that meet research-use-only standards for public health purposes for non-human subject research protocols for bio-surveillance

99%

TECHNICAL EXHIBIT B

DELIVERABLES SCHEDULE

A.001

QCP

(Para 1.5.1) Draft QCP due within 10 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

A.002

Analysis of Quality Control and Timeliness of Submittals

(Para 1.5.1.1)

A.003

Performance Issues or Potential Issues Report

(Par…