PWS-Cambodia_Surveillance_for_Emerging_Infectious_Diseases__Clinical_Trials.docx

PERFORMANCE WORK STATEMENT (PWS)

Surveillance for Emerging Infectious Diseases & Clinical Trials in Cambodia 12 January 2023

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: Provide Armed Forces Research Institute of Medical Sciences (AFRIMS) with procurement support, clinical and epidemiological services, purchase of supplies and equipment, transportation, communications and administrative support in Cambodia and neighboring countries. The period of performance shall be as follows:

1.2 Background: AFRIMS seeks to continue ongoing research projects involving surveillance for emerging infectious diseases and conduct clinical trials within Cambodia by the AFRIMS Department of Bacterial and Parasitic Diseases.

1.3 Scope: The primary objective of this award is to provide scientific, technical and administrative to support the project and study support for Surveillance for Emerging Infectious Disease and Clinical Trials. The services will include provision of clinical and epidemiological services, purchase of supplies and equipment, transportation, communications and administrative support. The Contractor shall support and subcontract with specific governmental and non-governmental entities at each location as directed by this Performance Work Statement (PWS) or by local laws or regulations in host nation countries. These entities will be referred to as “in-country medical health partners” for the remainder of this PWS. Specific work objectives and activities at each location as described in this PWS.

1.4 Objectives: Provide scientific, technical and administrative services for AFRIMS projects involving surveillance for emerging infectious diseases and conducting clinical trials within Cambodia. Pathogens that may be the subject of surveillance studies include respiratory viral pathogens, leptospirosis, bacterial pathogens, agents of parasitic disease including malaria, and other emerging infections. Products that may be evaluated in clinical trials include anti-malarial drugs and/or vaccines, anti-viral drugs, anti-microbial drugs, and other potential candidates with activity against infectious disease agents. In addition, the contractor must provide office space, utilities, as well as security per the regulations of the United States Embassy Security Office.

1.5 General Information:

1.5.1 Quality Control Plan (QCP): The Contractor’s existing quality assurance system shall be utilized in accordance with FAR 12.208.

1.5.2 Quality Assurance: The Government will evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the acceptable quality levels (performance thresholds).

1.5.3 Recognized Holidays: The following provides information on recognized holidays for the purpose of the PWS. If submittal of any documentation (e.g., deliverables, submittals, etc.) deadlines fall on a holiday, the closest work day prior to the holiday will apply as the deadline for submittal.

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

Queen’s Birthday June 18th

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 Operating Hours: Not Applicable

1.5.4.2 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.

1.5.4.3 Contractor Work Plan: Not Applicable

1.5.4.4 Training Holidays: WRAIR has historically granted military personnel training holidays as compensation for time that they spent in field training. These are typically combined with regular holiday leave schedules (for example, Christmas half days or day-on day-off schedules). Training holidays may affect access to military operated facilities. If scheduled work or access to facilities is required, coordination with occupants will be necessary or the work in affected facilities shall be rescheduled after the training holiday.

1.5.5 Place of Performance: The place of performance must take place within the city limits of Phnom Penh. The location must be in accordance with the security guidelines from the United States Embassy in Cambodia. In addition to the main site, there will also be work conducted in the following four (4) locations: Battambang, Kratie, Stung Treng, and Oddar Meanchey . Finally, work can be conducted at other locations if there is an increase in infectious diseases of inherent in the country or neighboring countries This will be conducted on an ad hoc basis.

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

1.6.1 Installation Access Requests: In the event that the contractor needs to visit a U.S. Installation or an Installation of a U.S. partner, the Contractor shall provide the Contracting Officer, via the COR, with a written request at least 30 calendar days prior to the planned visit. The request shall include a Biosketch or CV with a photo (A.001). Any installation-specific visiting approval requirements must be met prior to the visit.

1.6.2 Individual Termination or Expiration of Employment: The Contractor shall collect the installation access passes the same day employment of an individual has expired or has been terminated and shall return them to the issuing office within five (5) days (A.001) or the visit is completed

1.6.3 Contract Termination or Cancellation: Upon termination or cancellation of this contract, the Contractor shall collect all outstanding installation access passes and return them to the issuing office within five (5) days (A.001).

1.6.4 Common Access Cards (CAC) and CAC Log: Not Applicable

1.6.5 Background Checks:

1.6.5.1 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 Contracting Officer via the COR and the Requiring Activity Manager of each favorable background check within 30 days of receipt by the Contractor, identifying such with the appropriate contract number (A.002). The Contractor shall forward a copy to the Contracting Officer via the COR and the Requiring Activity Manager of each unfavorable background check within 30 days of receipt by the Contractor, identifying such with the appropriate contract number (A.002). 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.

1.6.5.2 Local Nationals and Third Country Nationals: Local national and third country national Contractors that work with or teach youths under the age of 18 years are subject to background checks as determined by the Requiring Activity Manager. As a minimum prior to beginning performance, Contractors employing local national and third country nationals shall furnish the Contracting Officer via the COR and the Requiring Activity Manager current documents required for working on a US installation, no later than five (5) days after contract award or during the post-award meeting (A.002). Forwarding correspondence from the Contractors shall identify the associated contract number.

1.6.6 Physical Security: Not applicable

1.6.7 Operations Security (OPSEC) Requirements: Not applicable

1.7 Key Control: Not Applicable

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 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 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 Contracting Officer, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the Contractor by the Contracting Officer. The designation letter states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates, or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is not authorized to obligate the Government. If the work is not written in the contract, the COR is not authorized to request new work. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract, perform inspections necessary in connection with contract performance, maintain written and oral communications with the Contractor concerning technical aspects of the contract, issue written interpretations of technical requirements, including Government drawings, designs, specifications, monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies, coordinate availability of Government property, and coordinate site entry of Contractor personnel.

1.10 Key Personnel:

The contractor shall provide Key Personnel in accordance with the minimum requirements listed within the Key Personnel table.

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 United States 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 with 30 days.

Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract 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.

KEY PERSONNEL TABLE

· Standard Operating Procedures (SOPs) for collection of clinical information and laboratory samples

· Processing of lab specimens and management of clinical data

· Properly collected sets of laboratory samples with accompanying clinical information

· Shipping of these on a regular basis to AFRIMS

· Must have license to practice medicine in Cambodia.

· Responsible for being Principal Investigator (PI) on Institutional Review Board (IRB) protocols.

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 (staging site, on-site office, desk or work area, etc.) shall contain a sign signifying the space is occupied by Contractor employee(s) to ensure that Government employees and the public know that they are not Government employees. The proposed sign shall be submitted to the Contracting Officer via the COR for review and acceptance 10 calendar days after contract award (A.003). Workspace sign location shall be coordinated with the COR. Contractor employees shall identify themselves by name and company affiliation when answering the telephone, presenting briefings, conducting or attending meetings, and seminars. All Contractor correspondence (written, facsimile, and email display) shall include their company name. Requirements for Contractor vehicles is addressed under Part 4 paragraph 4.4.

1.11.2 Contractor Identification Badges: Contractor personnel shall be easily identifiable through the display of badges IAW Contractor Identification (AE Reg. 27-715). The Contractor (to include subcontractors) shall provide each of their employees an easily readable identification badge. The badge must include the employee’s name, the contractor’s company name, the functional area of assignment, and a recent color photograph of the employee. Companies with U.S. Government contracts will require their employees to wear these badges visibly when performing work at Government workplaces unless this would be impractical because of mission or safety considerations. The Contractor shall collect all ID Badges upon completion of the contract or termination of employee. A listing of issued ID cards shall be furnished to the Contracting Officer prior to the contract performance date and updated as needed to reflect Contractor personnel changes (A.003).

1.12 Contractor Travel: Contractor employees may need to travel to and from Contractor facilities for training, site visits, enrollment, supply and sample transport, meetings, and clinical grand round data presentations.

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

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

1.15 Non-Disclosure Requirements: Performance under this contract may require the Contractor to access data and information proprietary to a Government agency, another Government Contractor, or of such nature that its dissemination or use other than as specified in this work statement would be adverse to the interests of the Government or others. Examples may include, but are not limited to, project funding proposals, human subject protection protocols, and unpublished study data. 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.

1.16 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 Non-Disclosure Statements: The Contractor shall provide signed non-disclosure agreements to the Government no later than 30 days (A.004) 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.

1.18 Organizational Conflict of Interest (OCI): Not applicable

1.19 Phase In /Phase Out Period: To minimize decreases in productivity and to prevent possible negative impacts on additional services, the Contractor shall have personnel on board, during the thirty (30) days phase in/ phase out periods. During the phase in period, the Contractor shall become familiar with performance requirements in order to commence full performance of services on the contract start date.

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

1.20.1 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 (A.005). 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.

(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 Contracting Officer 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:

(i) lab coat;

(ii) Long trousers;

(iii) latex gloves

1.20.2 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.

1.20.3 The Contractor shall complete and provide safety notifications required by host nation authorities and will provide documented proof to the Contracting Officer via the COR, no later than 30 days (A.005) that such notifications were made.

1.21 Environmental Compliance: Not applicable

1.22 Required Training: Not applicable

1.23 Authorization to Perform Services outside the U.S.: Not Applicable

1.24 Notice to Proceed: Not Applicable

1.25 Electromagnetic Compatibility Directive: Not Applicable

1.26 Government Property and Services: Not applicable

1.27 Conventional Forces Europe (CFE) Treaty Verification Inspection: Not Applicable

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 Defense Federal Acquisition Regulation Supplement (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.

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.

IRB Institutional Review Board

PART 3

GOVERNMENT PROPERTY (GP) AND SERVICES

3. Government Property and Services

3.1 Services: Not Applicable

3.2 Facilities: Not Applicable

3.3 Utilities: Not Applicable

3.4 Equipment: Not Applicable

3.5 Special Tooling and Test Equipment: Not Applicable

3.6 Materials: Not Applicable

3.7 Training: Not Applicable

3.8 Common Access Cards (CAC): Not applicable.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. Contractor Furnished Property and Services

4.1 General: Not Applicable

4.2 Secret Facility Clearance: Not Applicable

4.3 Materials: Not Applicable

4.4 Vehicles and Equipment: Not Applicable

4.5 Background Checks: Not Applicable

PART 5

SPECIFIC TASKS

5.1 Basic Services:

Provide scientific, technical and administrative for AFRIMS research projects involving surveillance for emerging infectious diseases and conduct clinical trials within Cambodia and neighboring countries. Pathogens that may be the subject of surveillance studies include respiratory viral pathogens, leptospirosis, bacterial pathogens, agents of parasitic disease including malaria, and other emerging infections. Products that may be evaluated in clinical trials include anti-malarial drugs and/or vaccines, anti-viral drugs, anti-microbial drugs, and other potential candidates with activity against infectious disease agents. In addition, the contractor must provide office space, utilities, as well as security per the regulations of the United States Embassy Security Office.

5.2 Tasks: Tasks consist of the following:

5.2.1 Clinical and Epidemiological Research Services. Contractor will procure services provided by qualified licensed medical and/or epidemiological staff (i.e., physicians, nurses, allied health professionals, and others) that will best suit project requirements for subject recruitment and enrollment, clinical and epidemiological evaluations, specimen collection, data gathering, and data management. Clinical assessments rendered may include vitals sign measurements, physical examinations, adverse event reports, treatment, and other clinical procedures as specified in clinical research protocols conducted under Good Clinical Practices (GLP). Staff will be compensated based on current market rates, and the human resources policies of the contractor.

5.2.2 Research Site Infrastructure. Contractor will locate and procure the use of physical sites for biomedical research such as clinics, health centers, laboratories, office space, and/or hospitals that are appropriate to the scientific requirements of the research projects. Infrastructure costs may include site rental and utilities as necessary to meet regulatory requirements and comply with the U.S. Embassy office space requirements for occupational health and safety, as well as U.S. Embassy and U.S. Army physical security requirements (A.006).

5.2.3 Supplies and Reagents. Contractor will facilitate procurement of supplies and reagents, needed to support AFRIMS research projects. Supplies include but are not limited to collection kits, general lab/analysis consumables, required safety personal protective equipment. This procurement support is especially relevant in situations where such supplies must be purchased locally in the Southeast Asia region (A.007).

5.2.4 Laboratory Testing. Contractor will procure services provided by qualified laboratory and technical staff (i.e., medical research technologists, technicians, microscopists, and laboratory workers) that will best suit project requirements for laboratory assessments required to support research activity. Assessments rendered may include complete blood counts, chemistries, urine testing, liver enzyme tests, immunological and diagnostic assays, clinical microscopy, molecular diagnostic analyses such as PCR, bacterial culture, and other lab tests as required (A.008).

5.2.5 Transportation. Contractor will procure transportation support for personnel, equipment, supplies, reagents, laboratory specimens, and study participants by whatever conveyance is required to meet project needs (A.009).

5.2.6 Sample shipment. Contractor will arrange for and ship clinical samples where advanced laboratory analysis is required. Shipping of samples will be variable depending on the patient or clinic location and the type of sample. Typically, samples are collected at a health clinic and shipped to laboratories in Battambang, Phnom Penh, or Bangkok. This will include obtaining the necessary permits and permissions, and procurement and coordination of shipping services (A.010).

5.2.7 Communications. Contractor will provide communications services and support to meet project needs. Communication services can include but are not limited to internet access, mobile phone access, satellite communications, and land-line communications (A.011).

5.2.8 Administrative services. Contractor will provide the administrative oversight necessary to execute the terms of this contract (A.012).

5.2.9 The Contractor shall also provide Medical Consultation and liaison-services on an AS-NEEDED basis during management of adverse events (AEs) and serious adverse events (SAEs) that may arise in the course of studies. The Medical Consultant will assist with communication and translation of key patient status and information between AFRIMS medical study staff and Cambodian medical staff to ensure professional and accurate management of AEs and SAEs that are referred to the Cambodian standard health care system (A.013).

5.2.10 Office space and utilities. The contractor shall provide the office space necessary to perform the required work associated with this requirement. In addition, the contractor must provide the utilities in order for the building to function (A.014).

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 5.2.1 Clinical and Epidemiological Research Services

95% Direct COR Observation/MPR Review

PRS#2 - PWS para 5.2.2 Research Site Infrastructure

95% Direct COR Observation/MPR Review

PRS#3 - PWS para 5.2.3 Supplies

95% Direct COR Observation/MPR Review

PRS#4 - PWS para 5.2.4 Laboratory Testing

95% Direct COR Observation/MPR Review

PRS#4 - PWS para 5.2.5 Transportation

95% Direct COR Observation/MPR Review

PRS#4 - PWS para 5.2.6 Sample Shipment

95% Direct COR Observation/MPR Review

PRS#4 - PWS para 5.2.7 Communications

95% Direct COR Observation/MPR Review

PRS#4 - PWS para 5.2.8 Administration Services

95% Direct COR Observation/MPR Review

PRS#4 - PWS para 5.2.9 Medical Consultation

95% Direct COR Observation/MPR Review

PRS#4 - PWS para 5.2.10 Office Space and Utilities

95% Direct COR Observation/MPR Review

TECHNICAL EXHIBIT B

DELIVERABLES SCHEDULE

A.001 Installation Access Request (Para 1.6.1)

Requests made at least 30 calendar days prior to installation visit.

Passes returned within 5 days of visit completion, employee termination, or contract termination or cancellation.

A.002 Background Check Reports (Para 1.6.5.1, 1.6.5.2) Local and Third Country Nationals Background Checks due 5 days after contract award or during the post-award meeting

For all employees, favorable or unfavorable background checks due within 30 days of receipt by the Contractor

A.003 Identification for Contractor Employees (Para 1.11.1, 1.11.2)

A.004 Non-Disclosure Agreements (Para 1.17)

A.005 Accident Prevention Plan and Safety Notifications (Para 1.20.1, 1.20.3) Accident Prevention Plan due before initiation of work at the job site

Safety notifications required by host nations due NLT 30 days of such notifications

A.006 Locate & Procure Physical Sites (Para 5.2.2)

A.007 Procurement of Supplies (Para 5.2.3)

A.008 Procurement of Qualified Laboratory and Technical Staff (Para 5.2.4)

A.009 Procurement of Transportation (Para 5.2.5)

A.010 Arrangement Clinical Sample Shipments (Para 5.2.6)

A.011 Communication Services (Para 5.2.7)

A.012 Administrative Oversight (Para 5.2.8)

A.013 Expert Medical Consultation (Para 5.2.9)

A.014 Provide Office Space (Para 5.2.10)

A.015 Provide Security Services (Para 5.2.11)

JUN 22