N62645-18-C-0063.docx

N6264518R0063

Section B - Supplies or Services and Prices

NAMRU-3 Research Support Services

FFP

Firm Fixed Price Task Orders The NTE amount on this CLIN is the maximum quantity that can be ordered against this CLIN.

FOB: Destination

MILSTRIP: ADVFY18RD00020

PURCHASE REQUEST NUMBER: ADVFY18RD00016

PSC CD: AN42

MAX

NET AMT

NAMRU-3 ODC and Travel

FFP

Firm Fixed Price Task Orders The NTE amount on this CLIN is the maximum quantity that can be ordered against this CLIN.

FOB: Destination

MILSTRIP: ADVFY18RD00020

PSC CD: AN42

MAX

NET AMT

Section C - Descriptions and Specifications

PWS

GLOBAL REQUIREMENT

U.S. Naval Medical Research Unit No. 3 (NAMRU-3), an infectious diseases research institute of the United States Navy based in Cairo, Egypt, conducts scientific research and public health initiatives throughout the Middle East, Eastern Europe, Central and Southeast Asia, North and West Africa. NAMRU-3 serves the Navy and Fleet Marine Forces in the above areas of operation by conducting research to study military relevant infectious disease threats in both active duty and civilian populations, specifically in the areas of preventive medicine, epidemiology, tropical medicine and infectious disease. NAMRU-3 has a detachment in Ghana which serves as a base for infectious disease research conducted in West Africa. The detachment is currently staffed by one active duty officer, one civilian scientist, and six locally engaged staff through the U.S. Embassy Accra.

There is not a NAMRU-3 laboratory or office facility in Ghana (outside the U.S. Embassy) and all research and surveillance activities require contracts with local institutions. NAMRU-3 works with the Noguchi Memorial Institute for Medical Research (NMIMR), Ghana Health Service (GHS), and Ghana Armed Forces (GAF). NAMRU-3 currently conducts prospective cohort studies of acute febrile illnesses, sexually transmitted infections, respiratory infections, dengue fever virus, leishmaniasis diagnostics, malaria surveillance, drug resistance, and immunology. These projects provide disease surveillance data to Department of Defense (DoD) and the Government of Ghana (GoG), while also building host country capacity in accordance with U.S. Government and Ghanaian guidelines.

Over the past 15 years NAMRU-3 has worked with NMIMR and researchers in Ghana to conduct infectious disease studies. These projects have demonstrated a successful sharing of knowledge and research techniques between NAMRU-3 and GoG. Collaborative projects are intended to be interactive and flexible enough to allow for response to developments related to the projects, such as influenza outbreak surveillance, and to provide mechanisms for real time data collected as part of DoD global disease surveillance. It is also the intention to initiate supplementary studies in areas of infectious disease within the life of this contract. Inherently most research projects have or are designed to have host country capacity building projects including but not limited to new techniques and/or technology. NAMRU-3 requires constant feedback regarding difficulties encountered by the contractor regarding these newly acquired skills and equipment.

In order to conduct this research in Ghana, NAMRU-3 requires the laboratory operational and scientific analysis support services described herein. These acquisitions will provide clinical field-based bio-surveillance, comprehensive support for laboratory operations, and contractor services for ongoing research activities with a goal of host nation capacity building and epidemiological studies conducted in consonance with the mission of NAMRU-3 GD. This requirement is unique in that it will be optimized for performance in Accra, Ghana and at remote field sites both within Ghana and in surrounding West African partner countries, with local (foreign) institutions.

C.2 Work Locations Work shall be performed at the following locations:

(a) Onsite at the Acute Febrile Illnesses (AFI) Laboratory located at Noguchi Memorial institute for Medical Research (NMIMR) in Accra, Ghana

(b) Additional collaborating department spaces at NMIMR

(c) Hospitals including 37 Military Hospital, Ghana Armed Forces Medical Receptions Stations, and several Ghana Health Service health facilities

(d) Collaborating institutions including laboratories within NMIMR, Ghana Health Service, Komfo Anokye Teaching Hospital (KATH), Kintampo Health Research Center, Kumasi Center for Collaborative Research in Tropical Medicine (KCCR), Navrongo Health Research Center, Phebe Hospital, Liberian Institute of Biomedical Research (LIBR), and Institut de Recherche en Sciences de la Sante (IRSS), as well as other local, regional, and international institutions that would benefit the NARMU-3 Ghana detachment’s mission.

(e) Field surveillance sites around Ghana and in surrounding West Africa countries, as needed by specific research requirements.

C.3 Specific Requirements and Areas of Research Contractor shall provide laboratory operations and scientific analysis support for the following research topic areas and tasking as required by NAMRU-3 GD:

C.3.1 Laboratory Operational Support Services NAMRU-3 GD requires the expertise to operate an advanced diagnostic laboratory that utilizes cutting-edge techniques in molecular biology, microbiology, conventional bacteriology and parasitology, immunology, diagnostic tissue culture, and laboratory capacity building. This will include the capability and expertise to work with pathogens in Biosafety Level Two (BSL-2) or lower conditions; however, due to the unpredictable risk associated with mutating and rapidly transmissible emerging pathogens in developing regions such as West African, BSL-3 resources will also be needed to support potential outbreak response activities.

C.3.2 Active Field-based Biosurveillance NAMRU-3 GD requires expertise to support biosurveillance studies involving the collection of specimens at various sites throughout Ghana and in surrounding West African countries. Specimens will then be processed for testing at the contractor’s site and/or NAMRU-3 GD, in accordance with established laboratory SOP. Contractor will also assist in the development of conclusive reports derived from such testing, which will be used to inform research sponsors, public health initiatives, and other stakeholders.

C.3.3 Molecular Biology The contractor shall conduct testing and diagnostic analysis of human, environmental and animal samples utilizing PCR, RT-PCR, and sequencing methods. The contractor shall have expertise to utilize current methods and to operate diagnostic equipment including, but not limited to, the Applied Biosystems 7300/7500, LightCycler 480 II, Luminex 200, Sanger sequening, Ilumina MySeq and conventional PCR. The contractor shall be required to follow established NAMRU-3 GD Standard Operating Procedures (SOPs) for testing, analysis, data reporting and troubleshooting.

C.3.4 Conventional Bacteriology and Parasitology The contractor shall be able to provide laboratory diagnosis of human, environmental and animal samples including blood, stool, sputum, body fluids, respiratory swabs, wound swabs, and environmental swabs. The contractor shall be proficient in standardized techniques as outlined by the Clinical and Laboratory Standards Institute (http://clsi.org/) and in accordance with the College of American Pathologists (http://www.cap.org/) guidelines.

C.3.5 Immunology The contractor shall conduct immunological assays on blood and serum collected from human and animal sources to test for evidence of exposure to pathogenic organisms of interest. Specific techniques required include Enzyme Linked ImmunoSorbent Assays (ELISA), flow cytometry, Indirect Hemagglutination Assays (IHA), Luminex MagPix, and Rapid Diagnostic Tests (RDTs). The contractor shall also be responsible for the testing and validation of novel immunological tests as they become available.

C.3.6 Diagnostic Tissue Culture The contractor shall conduct tissue culture activities is support of viral pathogen detection and characterization. The contractor shall provide support in the maintenance of cultured cell lines.

C.3.7 Laboratory Capacity Building The contractor shall provide support services to conduct host nation laboratory training programs in Ghana as outlined by NAMRU-3 GD. These programs are designed to assist Ghana in achieving the World Health Organization 2005 International Health Regulations (IHR2005) and developing the capacity to support NAMRU-3 projects. The contractor shall provide support and training on study protocols and SOPs to collaborating institutions and laboratories at the direction of NAMRU-3. The support shall focus on establishing basic laboratory diagnostic capacity and in some cases advanced capacity in host nation laboratories.

C.3.8 Specimen Accessioning and Archiving The contractor shall provide support for transport, accessioning, processing and archiving of all samples collected as outlined in NAMRU-3 GD study protocols and SOPs.

C.3.9 Entomology The contractor shall provide services and support for the collection and identification of insect disease vectors in Ghana, including mosquitoes, sandflies, fleas, ticks, mites, and other arthropods of medical importance. Such vector collection shall be conducted in support of research projects conducted by NAMRU-3 GD on vector-borne diseases. Services shall also encompass the evaluation of insect control methods and bioassays that require the use of an insectary. The contractor shall also support subcontracts with local partners and institutions in Ghana and throughout West Africa. The contractor will be able to support microscopic as well as molecular analysis of the vectors and additional pathogen analysis using immunoassays and molecular assays as outlined above.

C.3.10 Medical Management and Scientific Support Services The contractor shall provide services to support the management of all NAMRU-3 GD study activities. The contractor shall liaise with outside study partners including, but not limited to, entities of the Ghana Health Service and Ghana Armed Forces, to provide support for the execution of NAMRU-3 studies. The contractor shall provide oversight to ensure that all activities it engages in for NAMRU-3 studies are conducted in accordance with SOPs and all applicable host nation and United States regulations governing human use research. The contractor shall also ensure that all data related to the studies is collected in accordance with study protocols, entered in secure databases and analyzed as required for reports, publications or other external documentation.

C.3.11 Data Entry and Analysis The contractor shall provide data entry and analysis services to ensure that all required study data is captured and entered into secure databases. This data may include but not be limited to demographics, clinical history, laboratory data, bio-informatics, advanced molecular analysis, and data related to field surveillance. The contractor shall organize all data as required by NAMRU-3 GD and provide statistical analysis services to evaluate the data.

C.3.14 Ancillary Laboratory Support Services The contractor shall provide any ancillary laboratory support services incidental to performance of normal laboratory functions, to ensure proper laboratory operational efficiency and functionality. Such support may include (when operating in other than NMIMR facilities), but is not limited to, janitorial services, supply management, and handyman/repair services. The contractor shall also be responsible for the removal and proper disposal of all regular waste, medical waste and chemical waste. Medical waste shall be properly sterilized onsite and incinerated. Chemical waste shall be collected and disposed of in accordance with Ghanaian regulations. The contractor shall cover all ferry, taxi, parking, communications (cellphones, phone cards, wireless internet access when out in the field sites or supporting hospitals) or other incidental fees that occur during the execution of this contract. The contractor shall be responsible for ensuring that all certifications, accreditations, travel documentation (visas, passports, etc.) are provided to conduct the requirements outlined in the contract. The contractor shall provide certification that all disposal activities have been conducted in accordance with Ghanaian Regulations.

C.4 Travel and Other Direct Costs C.4.1 Travel In the performance of this contract, there may be travel within Ghana and throughout West Africa to research field sites, supply management/logistical support locations, meetings with in-country partners, laboratory capacity development sites, and trainings. Field site destinations include urban, peri-urban, and rural areas that may lack access to modern amenities. All travel shall be approved via email by the NAMRU-3 GD project officer and the COR prior to commencing. Fee for profit may not be applied to any travel. All travel shall be conducted in accordance with US Department of Defense (DoD) Joint Travel Regulations (JTR) and US Department of State (DoS) regulations. Specific travel requirements (destinations, number of travelers, amounts) will be addressed at the task order level.

C.4.2 Other Direct Costs (ODCs) There may be ODCs required in performance of this contract. ODCs will be specified at the task order level, but may include contractor-procured laboratory supplies, equipment, disposable and non-disposable items, other research supplies, IT support equipment, and subcontractor and consultant services incidental to performance.

C.5 Local Staffing Sources For this contract it is anticipated that the prime contractor in Ghana will also work in conjunction with local solution partners or subcontractors to ensure that local sourcing is utilized to the fullest, thereby giving NAMRU-3 the most cost effective solution, while maintaining an acceptable level of technical performance in collaborative research initiatives. The contractor will ensure compliance with all local tax and labor laws in the country of operation and will abide by the cognizant US command of the relevant regions and the US State Department, as there may be high risk when entering into the area.

C.6 Period of Performance The ordering period for this contract shall be 60 months.

C.8 Anticipated Labor Categories Anticipated labor categories are shown below and shall be used for the duration of this contract in negotiating Firm Fixed Price Task Orders.

C.8.1 Laboratory Technician Description: Using standardized and accredited laboratory procedures will execute laboratory assays in molecular biology, immunology, parasitology, bacteriology and virology in direct support of medical research and clinical projects. The technician will:

· Maintain proper biomedical research laboratory notebook for all study related material such as assays performed, data interpretation and critical analysis

· Procure laboratory supplies, reagents, media and equipment to ensure continuity of laboratory operations

· Be responsible for accessioning, processing, and long-term cryopreservation of all specimens and samples

· Work with the data and field departments to ensure proper collection and transportation of specimens per study specific protocols

· Provide training to field personnel as required on laboratory procedures and specimen collection

Qualifications:

· Bachelor’s degree in biology or chemistry, or an equivalent degree at a university, or completion of a laboratory certificate

· At least one year of laboratory experience or 3- 4 years work experience in biomedical sciences

· English Level II proficiency in speaking, reading, and writing

· Proficiency in MS excel and MS Access software

C.8.2 Senior Research Scientist Description: Provide senior oversight and execution of research for clinical field surveillance and/or laboratory-based activities while at contractor facilities.

Qualifications:

· Ph.D., M.D., or equivalent with emphasis in Molecular Biology, Microbiology, or Medical Technology

· 8-12 years research experience

· Advanced knowledge of current molecular and microbiology research technologies, laboratory practices, and clinical bio-surveillance methods

C.8.3 Research Assistant Description:

· Work closely with senior scientists

· Provide general assistance in the execution of research operations such as data and specimen collection, data management, laboratory analyses, preparation of documentation and coordination of shipments

Qualifications:

· Master’s degree with emphasis in Biology, Microbiology or Medical Technology

· 1-2 years of research experience

C.8.4 Entomology/Field Technician Description:

· Design, supervise and conduct all NAMRU-3 entomology projects along with NAMRU-3 officers

· Assess current studies and provide input for the design and direction of future studies

· Work with US military and host nation entomology programs to conduct surveillance of vector threats in Ghana

· Assist with managing supplies and ordering for entomology section

· Advises on technical procedures, techniques and equipment, supplies and maintains conformance with NAMRU-3 standard operating procedures

· Prepare data for submission to NAMRU-3 officers for reports

· Contribute to composition of technical documents including reports and peer reviewed articles

Qualifications:

· Ph.D. or Master’s Degree in biology (entomology focus) or related biochemical science

· 5 years of laboratory experience with highly sophisticated laboratory equipment

· 5 years of entomology experience including trapping and speciation of human health threat vectors

· Ability to properly design insect sampling programs, operate insect traps and record relevant data associated with programs

· Ability to work in the field, operate cumbersome equipment, and perform functions that require manual dexterity

· Must have conducted previous field studies with preference given to studies conducted in West Africa

· Working knowledge of molecular biology as it pertains to vector identification and pathogen carriage in insects

· English Level III proficiency in speaking, reading, and writing

· Proficiency with MS Excel, MS Access, and MS Office

C.8.6 Data Entry Clerk Description:

· Process, screen, and enter questionnaires, consent forms, data, report presentations into the program database

· Ensure all epidemiological data, lab data, and results are accurately inputted and organized in an easily retrievable fashion

· Manages data and prepares accurate reports as required

· Receives clinical, laboratory, and demographic data for entry into log books and lap-top computers

· Trained in executing double entry data and conflict resolution in the data

Qualifications:

· High-school diploma or equivalent

· Two years computer experience using relational database management software

· Computer literate in MS Word, Excel and Access

· English Level II proficiency in reading, writing and speaking C.8.7 Research Coordinator Description:

· Responsible for facilitating research execution tasks such as data collection, data management, graphical data presentation, clinical enrollment, and preparation of IRB documents and protocols

Qualifications:

· Bachelor’s degree in a science related field, Master’s degree preferred

· 2-4 years’ experience in research required

C.9 QASP

TASK/

DELIVERABLE

PERFORMANCE

STANDARD

PERFORMANCE

INDICATOR/

ACCEPTABLE

LEVEL OF

PERFORMANCE

METHOD OF

SURVEILLANCE

PERFORMANCE RATING

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful and informative data and information.

Contractor's technical performance meets all contract requirements. Problems that are encountered are minor in nature, as follows: does not cause a delay in schedule; does not cause costs to increase; involves minimal effort to fix; and does not affect overall contractor performance.

All matters resolved in a satisfactory and timely manner.

Random inspection

Are study reports complete and are they compliant with various government regulations?

Assignment of performance rating and criteria:

Excellent Performance meets and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems encountered were minor and resolved in a highly effective manner, having no impact on schedule, costs, and overall contractor performance.

Acceptable Performance meets most contract requirements. Performance delivered with minimal re-performance/rework; problems encountered were minor and resolved in a satisfactory manner.

Unacceptable Performance fails to meet many contract requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule, cost, and/or overall contractor performance. Significant re-performance or rework required.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor's technical performance meets all contract requirements.

Problems that were encountered were minor in nature, as follows: does not cause a delay in schedule; does not cause costs to increase; involves minimal effort to fix; and does not affect overall contractor performance

All matters resolved in a satisfactory and timely manner.

Random Inspection

Is the contractor meeting established timeframes?

Assignment of performance rating and criteria:

Excellent Performance meets all contract timeliness requirements. Problems that are encountered are minor and resolved in a highly effective manner, having no impact on schedule, cost, and overall contractor performance.

Acceptable Performance meets most timeliness requirements. Performance delivered with minimal re-performance/rework; problems encountered were minor and resolved in a satisfactory manner. Minimal impact on schedule, cost, and overall contractor performance.

Unacceptable Performance fails to meet many timeliness requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule, cost, and/or overall contractor performance.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information Contractor's technical performance meets all contract requirements.

Problems encountered were minor in nature, as follows: does not cause a delay in schedule; does not cause increase costs;

involves minimal effort to fix; and does not affect overall contractor performance

All matters resolved in a satisfactory and timely manner.

Random Sampling and feedback from client

Is the contractor committed to high customer satisfaction? How proactive is the contractor? Is the contractor providing positive value to the government?

Assignment of performance rating and criteria:

Excellent Performance meets and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems encountered were minor and resolved in a highly effective manner, having no impact on schedule, costs, and overall contractor performance.

Acceptable Performance meets most contract requirements. Performance delivered with minimal re-performance/rework; problems encountered were minor and resolved in a satisfactory manner. Minimal impact on schedule, cost, and overall contractor performance.

Unacceptable Performance fails to meet many contract requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule, cost, and/or overall contractor performance. Significant re-performance or rework required.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor's technical performance meets all contract requirements.

Problems that are encountered are minor in nature, as follows: does not cause a delay in schedule; does not cause increased costs;

involves minimal effort to fix; and does not affect overall contractor performance

All matters resolved in a satisfactory and timely manner.

Random Sampling

What is the government’s overall satisfaction with the contractor?

Assignment of performance rating and criteria:

Excellent Performance meets and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems encountered were minor and resolved in a highly effective manner, having no impact on schedule, costs, and overall contractor performance.

Acceptable Performance meets most contract requirements. Performance delivered with minimal re-performance/rework; problems encountered were minor and resolved in a satisfactory manner. Minimal impact on schedule, cost, and overall contractor performance.

Unacceptable Performance fails to meet many contract requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule, cost, and/or overall contractor performance. Significant re-performance or rework required.

SUPTXT204-9400(1-17)

Contractor Unclassified Access to Federally Controlled Facilities, Sensitive Information, Information Technology (IT) Systems or Protected Health Information

Homeland Security Presidential Directive (HSPD)-12, requires government agencies to develop and implement Federal security standards for Federal employees and contractors. The Deputy Secretary of Defense Directive-Type Memorandum (DTM) 08-006 – “DoD Implementation of Homeland Security Presidential Directive – 12 (HSPD-12)” dated November 26, 2008 (or its subsequent DoD instruction) directs implementation of HSPD-12. This clause is in accordance with HSPD-12 and its implementing directives.

APPLICABILITY

This text applies to contractor employees requiring physical access to any area of a federally controlled base, facility or activity and/or requiring access to a DoN or DoD computer/network/system to perform certain unclassified sensitive duties. This clause also applies to contractor employees who access Privacy Act and Protected Health Information, provide support associated with fiduciary duties, or perform duties that have been identified as National Security Position, as advised by the command security manager. It is the responsibility of the responsible security officer of the command/facility where the work is performed to ensure compliance.

Each contractor employee providing services at a Navy Command under this contract is required to obtain a Department of Defense Common Access Card (DoD CAC). Additionally, depending on the level of computer/network access, the contract employee will require a successful investigation as detailed below.

ACCESS TO FEDERAL FACILITIES

Per HSPD-12 and implementing guidance, all contractor employees working at a federally controlled base, facility or activity under this clause will require a DoD CAC. When access to a base, facility or activity is required contractor employees shall in-process with the Command’s Security Manager upon arrival to the Command and shall out-process prior to their departure at the completion of the individual’s performance under the contract.

ACCESS TO DOD IT SYSTEMS

In accordance with SECNAV M-5510.30, contractor employees who require access to DoN or DoD networks are categorized as IT-I, IT-II, or IT-III. The IT-II level, defined in detail in SECNAV M-5510.30, includes positions which require access to information protected under the Privacy Act, to include Protected Health Information (PHI). All contractor employees under this contract who require access to Privacy Act protected information are therefore categorized no lower than IT-II. IT Levels are determined by the requiring activity’s Command Information Assurance Manager.

Contractor employees requiring privileged or IT-I level access, (when specified by the terms of the contract) require a Single Scope Background Investigation (SSBI) or T5 or T5R equivalent investigation , which is a higher level investigation than the National Agency Check with Law and Credit (NACLC)/T3/T3R described below. Due to the privileged system access, an investigation suitable for High Risk national security positions is required. Individuals who have access to system control, monitoring, or administration functions (e.g. system administrator, database administrator) require training and certification to Information Assurance Technical Level 1, and must be trained and certified on the Operating System or Computing Environment they are required to maintain.

Access to sensitive IT systems is contingent upon a favorably adjudicated background investigation. When access to IT systems is required for performance of the contractor employee’s duties, such employees shall in-process with the Navy Command’s Security Manager and Information Assurance Manager upon arrival to the Navy command and shall out-process prior to their departure at the completion of the individual’s performance under the contract. Completion and approval of a System Authorization Access Request Navy (SAAR-N) form is required for all individuals accessing Navy Information Technology resources. The decision to authorize access to a government IT system/network is inherently governmental. The contractor supervisor is not authorized to sign the SAAR-N; therefore, the government employee with knowledge of the system/network access required or the COR shall sign the SAAR-N as the “supervisor”.

The SAAR-N shall be forwarded to the Command’s Security Manager at least 30 days prior to the individual’s start date. Failure to provide the required documentation at least 30 days prior to the individual’s start date may result in delaying the individual’s start date.

When required to maintain access to required IT systems or networks, the contractor shall ensure that all employees requiring access complete annual Information Assurance (IA) training, and maintain a current requisite background investigation. The Contractor’s Security Representative shall contact the Command Security Manager for guidance when reinvestigations are required.

INTERIM ACCESS

The Command's Security Manager may authorize issuance of a DoD CAC and interim access to a DoN or DoD unclassified computer/network upon a favorable review of the investigative questionnaire and advance favorable fingerprint results. When the results of the investigation are received and a favorable determination is not made, the contractor employee working on the contract under interim access will be denied access to the computer network and this denial will not relieve the contractor of his/her responsibility to perform.

DENIAL OR TERMINATION OF ACCESS

The potential consequences of any requirement under this clause including denial or termination of physical or system access in no way relieves the contractor from the requirement to execute performance under the contract within the timeframes specified in the contract. Contractors shall plan ahead in processing their employees and subcontractor employees. The contractor shall insert this clause in all subcontracts when the subcontractor is permitted to have unclassified access to a federally controlled facility, federally-controlled information system/network and/or to government information, meaning information not authorized for public release.

CONTRACTOR’S SECURITY REPRESENTATIVE

The contractor shall designate an employee to serve as the Contractor’s Security Representative. Within three work days after contract award, the contractor shall provide to the requiring activity’s Security Manager and the Contracting Officer, in writing, the name, title, address and phone number for the Contractor’s Security Representative. The Contractor’s Security Representative shall be the primary point of contact on any security matter. The Contractor’s Security Representative shall not be replaced or removed without prior notice to the Contracting Officer and Command Security Manager.

BACKGROUND INVESTIGATION REQUIREMENTS AND SECURITY APPROVAL PROCESS FOR CONTRACTORS ASSIGNED TO NATIONAL SECURITY POSITIONS OR PERFORMING SENSITIVE DUTIES

Navy security policy requires that all positions be given a sensitivity value based on level of risk factors to ensure appropriate protective measures are applied. Contractor employees under this contract are recognized as Non-Critical Sensitive [ADP/IT-II] positions when the contract scope of work require physical access to a federally controlled base, facility or activity and/or requiring access to a DoD computer/network, to perform unclassified sensitive duties. This designation is also applied to contractor employees who access Privacy Act and Protected Health Information (PHI), provide support associated with fiduciary duties, or perform duties that have been identified as National Security Positions. At a minimum, each contractor employee must be a US citizen and have a favorably completed NACLC or T3 or T3R equivalent investigation to obtain a favorable determination for assignment to a non-critical sensitive or IT-II position. The investigation consists of a standard NAC and a FBI fingerprint check plus law enforcement checks and credit check. Each contractor employee filling a non-critical sensitive or IT-II position is required to complete:

Failure to provide the required documentation at least 30 days prior to the individual’s start date shall result in delaying the individual’s start date. Background investigations shall be reinitiated as required to ensure investigations remain current (not older than 10 years) throughout the contract performance period. The Contractor’s Security Representative shall contact the Command Security Manager for guidance when reinvestigations are required.

Regardless of their duties or IT access requirements ALL contractor employees shall in-process with the Command’s Security Manager upon arrival to the command and shall out-process prior to their departure at the completion of the individual’s performance under the contract. Employees requiring IT access shall also check-in and check-out with the Navy Command’s Information Assurance Manager. Completion and approval of a System Authorization Access Request Navy (SAAR-N) form is required for all individuals accessing Navy Information Technology resources. The SAAR-N shall be forwarded to the Navy Command’s Security Manager at least 30 days prior to the individual’s start date. Failure to provide the required documentation at least 30 days prior to the individual’s start date shall result in delaying the individual’s start date.

The contractor shall ensure that each contract employee requiring access to IT systems or networks complete annual Information Assurance (IA) training, and maintain a current requisite background investigation. Contractor employees shall accurately complete the required investigative forms prior to submission to the Command Security Manager. The Command’s Security Manager will review the submitted documentation for completeness prior to submitting it to the Office of Personnel Management (OPM); Potential suitability or security issues identified may render the contractor employee ineligible for the assignment. An unfavorable determination is final (subject to SF-86 appeal procedures) and such a determination does not relieve the contractor from meeting any contractual obligation under the contract. The Command’s Security Manager will forward the required forms to OPM for processing. Once the investigation is complete, the results will be forwarded by OPM to the DoD Central Adjudication Facility (CAF) for a determination.

If the contractor employee already possesses a current favorably adjudicated investigation, the contractor shall submit a Visit Authorization Request (VAR) via the Joint Personnel Adjudication System (JPAS) or a hard copy VAR directly from the contractor’s Security Representative. Although the contractor will take JPAS “Owning” role over the contractor employee, the Command will take JPAS "Servicing" role over the contractor employee during the hiring process and for the duration of assignment under that contract. The contractor shall include the IT Position Category per SECNAV M-5510.30 for each employee designated on a VAR. The VAR requires annual renewal for the duration of the employee’s performance under the contract.

BACKGROUND INVESTIGATION REQUIREMENTS AND SECURITY APPROVAL PROCESS FOR CONTRACTORS ASSIGNED TO OR PERFORMING NON-SENSITIVE DUTIES

Contractor employee whose work is unclassified and non-sensitive (e.g., performing certain duties such as lawn maintenance, vendor services, etc. ...) and who require physical access to publicly accessible areas to perform those duties shall meet the following minimum requirements:

To be considered for a favorable trustworthiness determination, the Contractor’s Security Representative must submit for all employees each of the following:

The contractor shall ensure each individual employee has a current favorably completed National Agency Check with Written Inquiries (NACI) or T1 equivalent investigation, or ensure successful FBI fingerprint results have been gained and investigation has been processed with OPM

Failure to provide the required documentation at least 30 days prior to the individual’s start date may result in delaying the individual’s start date.

* Consult with your Command Security Manager and Information Assurance Manager for local policy when IT-III (non-sensitive) access is required for non-US citizens outside the United States.

Section E - Inspection and Acceptance

COR

CONTRACTING OFFICER’S REPRESENTATIVE (COR)

(a) For the purpose of this clause, the Contracting Officer’s Representative (COR) is the duly authorized representative of the Contracting Officer.

(b) The COR for this contract will be appointed at the time the base contract is awarded.

(c) The COR will perform inspection and acceptance of services to be provided. Inspection and acceptance will be performed at the locations listed in the contract or task orders.

Contract Specialist: To Be Determined Phone Number:

Email:

Contracting Officer’s Representative: To Be Determined Phone Number:

Email:

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLAUSES INCORPORATED BY REFERENCE

Section F - Deliveries or Performance

DELIVERY INFORMATION

09-JUL-2023

RECEIVING OFFICER

PSC 452, BOX 5000

FPO AE 09835-0007

00-202-23480465 FOB: Destination N61751

09-JUL-2023

FOB: Destination N61751

Section G - Contract Administration Data

CLAUSES INCORPORATED BY FULL TEXT

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013)

(a) Definitions. As used in this clause--

Department of Defense Activity Address Code (DoDAAC) is a six position code that uniquely identifies a unit, activity, or organization.

Document type means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

Local processing office (LPO) is the office responsible for payment certification when payment certification is done external to the entitlement system.

(b) Electronic invoicing. The WAWF system is the method to electronically process vendor payment requests and receiving reports, as authorized by DFARS 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall--

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.acquisition.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this Web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via Web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor must use the following information when submitting payment requests and receiving reports in WAWF for this contract/order:

(1) Document type. The Contractor shall use the following document type(s).

See Individual Task Order

(2) Inspection/acceptance location. The Contractor shall select the following inspection/acceptance location(s) in WAWF, as specified by the contracting officer.

N/A

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table* Field Name in WAWF Data to be entered in WAWF

(4) Payment request and supporting documentation. The Contractor shall ensure a payment request includes appropriate contract line item and subline item descriptions of the work performed or supplies delivered, unit price/cost per unit, fee (if applicable), and all relevant back-up documentation, as defined in DFARS Appendix F, (e.g. timesheets) in support of each payment request.

(5) WAWF email notifications. The Contractor shall enter the email address identified below in the “Send Additional Email Notifications” field of WAWF once a document is submitted in the system.

WAWF Acceptor/COR Email Address: TBD

(g) WAWF point of contact. (1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's WAWF point of contact.

usn.detrick.navmedlogcomftdmd.list.nmlc-wawf@mail.mil

(2) For technical WAWF help, contact the WAWF helpdesk at 866-618-5988.

(End of clause)

Section H - Special Contract Requirements

SPECIAL CONTRACT REQUIREMENTS

INVENTION DISCLOSURES AND REPORTS

(a) In accordance with the requirements of the Patent Rights clause (FAR 52.227-13) of this contract, the contractor shall submit “Report of Inventions and Subcontracts” (DD Form 882) along with written disclosure of inventions to the designated Contract Administrator.

(b) The Contract Administrator will forward such reports and disclosures directly to the appropriate Patent Counsel, designated below, for review and recommendations, after which the reports will be returned to the Contract Administrator.

Address of Patent Counsel:

Office of Legal and Technology Services Naval Medical Research Center (Code 1URO) 503 Robert Grant Avenue, Suite 1W/15 Silver Spring, MD 20910

(c) The above designated Patent Counsel will represent the Procurement Contracting Officer with regard to invention reporting matters arising under this contract.

(d) A copy of each report and disclosure shall be forwarded to the Procuring Contracting Officer.

(e) The contractor shall furnish the Contracting Officer a final report within three (3) months after completion of the contracted work listing all subject inventions or certifying that there were no such inventions, and listing all subcontracts at any tier containing a patent rights clause or certifying that there were no such subcontracts.

PATIENT CARE AND MEDICAL LIABILITY INSURANCE

The character of services for health care workers that are providing patient care in clinical or administrative tasks under this contract will be categorized as non-personal services as provided for by Federal Acquisition Regulation (FAR) Subpart 37.4. Patient care will be incidental to research activities or projects supported under this contract. Alleged acts of medical malpractice by non-personal health care workers are not covered under the Federal Tort Claims Act and the contractor shall indemnify the Government against legal action alleging malpractice by such workers by way of indemnification and medical liability insurance provided by the contractor. Insurance as prescribed by FAR clause 52.237-7 shall be required for those medical personnel such as physicians or nurses providing patient care in clinical or administrative tasks consistent with standard coverage prevailing within the local community as to the specific medical specialty.

NOTICE REGARDING THE DISSEMINATION OF EXPORT-CONTROLLED TECHNICAL DATA

(a) Export of information contained herein, which includes release to foreign nationals within the United States, without first obtaining approval or license from the Department of State for items controlled by the International Traffic in Arms Regulations (ITARS), or the Department of Commerce for items controlled by the Export Administration Regulations (EAR), may constitute a violation of law.

(b) For violation of export laws, the contractor, its employees, officials or agents are subject to:

(c) The Government shall not be liable for any unauthorized use or release of export-controlled information, technical data or specifications in this contract.

(d) The contractor shall include the provisions or paragraphs (a) through (c) above in any subcontracts awarded under this contract.

PROTECTION OF HUMAN SUBJECTS

(a) The performance of research involving human subjects shall be conducted in accordance with Defense Federal Acquisition Regulation Supplement (DFARS) clause 252.235-7004 “Protection of Human Subjects,” 32 CFR 219 “The Common Rule,” 10 USC 980 “Limitation on Use of Humans as Experimental Subjects,” Department of Defense (DoD) Instruction 3216.02 “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research,” and Secretary of the Navy Instruction 3900.39 (series) “Human Research Protection Program,” as well as other applicable federal and state law and regulations, and Department of the Navy guidance. The Contractor must be cognizant of and abide by the additional restrictions and limitations imposed on the DoD regarding research involving human subjects, specifically as they regard vulnerable populations, recruitment of military research subjects, and informed consent and surrogate consent and chemical and biological agent research. Food and Drug Administration regulation and policies may also apply. The Contractor shall rely on the local command’s designated Institutional Review Board (IRB) as the IRB of record for the research to be supported under the contract. The Contractor shall also comply with all research training requirements directed by the local command.

(b) The Contractor shall hold an active (i.e., not expired) Federalwide Assurance (FWA) appropriate for research to be supported under the contract. The FWA shall remain active for the duration of the contract. The FWA is issued by the Department of Health and Human Services.

(c) The following requirements must be completed prior to the Contractor’s performance of research involving human subjects or expenditure of funding on such effort, whichever occurs first:

(1) The Contractor shall enter into a DoD Institutional Agreement for Institutional Review Board (IRB) Review (IAIR) with the local command. The IAIR will apply to all human subject research supported under the contract. The IAIR shall be executed by the parties no later than 30 days after the effective date of the contract, or before commencement of performance of research involving human subjects or expenditure of funding, whichever occurs first.

(2) Contractor personnel providing support under the contract shall complete initial and ongoing research ethics and human subject protections training appropriate to each individual’s…