B08_-_SOLICITATION_AMENDMENT__0003_ATTACHMENT__1_-_PERFORMANCE_WORK_STATEMENT.pdf

PERFORMANCE WORK STATEMENT (PWS)

DEVELOPMENT OF NOVEL MONOCLONAL ANTIBODIES AND LONGITUDINAL

STUDY OF IMMUNE RESPONSES USING SERUM AND PBMC'S OF INFECTIOUS

DISEASE SURVIVORS

FOR

UNITED STATES ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS

DISEASES (USAMRIID)

SECTION 1: GENERAL INFORMATION

1.1 Introduction. Since 1969, the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) has served as the Department of Defense's (DoD) lead laboratory for medical biological defense research. While its core mission is to protect the warfighter from biological threats, USAMRIID also investigates disease outbreaks and threats to public health. Research conducted at USAMRIID leads to medical solutions - therapeutics, vaccines, diagnostics, and information that benefit both military personnel and civilians. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command (USAMRMC) at Fort Detrick, located in Frederick, MD.

1.2. Mission. The mission of USAMRIID is to provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents.

1.2.1. Specifically, the Viral Immunology Branch seeks to understand the relationship between human immunity and viral diseases, and use that knowledge to develop medical countermeasures to protect the Warfighter.

1.3. Purpose. The purpose of this contract is for the collection and shipping of whole blood and blood products to support the following tasks: development of monoclonal antibody therapeutics, evaluation of the humoral and cellular immune responses in humans to Marburgvirus or Venezuelan Equine Encephalitis virus infection, and examining specific memory immunity and its persistence over time.

1.3.1. Contractor shall provide all personnel, materials, equipment, tools, transportation, supervision and other items necessary to identify and track survivors of Marburg virus disease (MVD) outbreaks in Uganda and Venezuelan equine encephalitis (VEE) outbreaks in Panama, develop a database to assess the longitudinal responses of immunological memory in these individuals as described in the Specific Tasks (Part 3 of this PWS. Subcontracting to local contractors with greater familiarity and expertise in the collection locales is encouraged.

1.4. Scope. The primary objective of this requirement is to identify and track survivors of MVD and VEE outbreaks in Uganda and Panama, respectively, develop a database to assess the immune status of these individuals as described below. Both B and T cell responses will be tracked over time to develop a picture of the protective immune response in humans. This study will involve collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID).

1.4.1. Identify a cohort of survivors of MVD (Uganda) and VEE (Panama) and perform initial whole blood collection. Blood samples will be delivered to the in-country host laboratory expeditiously following each collection.

1.4.2. Develop a database to track survivors over time, and assess their immune status.

1.4.3. Every six (±2) months perform follow-up collection of survivor’s sera and lymphocyte samples (whole blood), as in 1.4.1.

1.4.4. Assist USAMRIID and/or host country personnel in blood processing and analysis as needed.

1.4.5. Ship blood products to laboratories at USAMRIID, or to collaborators, as needed.

SECTION 2: GENERAL REQUIREMENT

2.1. PERFORMANCE

2.1.1. Place of Performance: Place of Performance will be UGANDA (In-Country), PANAMA (In- Country), and the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). Travel between these locations may be required.

2.1.1.1. Duty Hours. Contractor personnel shall perform services during regular duty hours, Monday thru Friday, during core hours of operation 7:30am to 4:30pm.

2.1.1.1.1. The contractor shall not perform services on days designated as a Federal Holidays by Federal Status, Executive Order, Presidential Proclamation or Notice from the Installation Commander.

2.1.1.1.2. Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays that services shall not be performed:

a. New Year’s Day, January 1st

b. Martin Luther King’s Birthday, 3rd Monday in January

c. President’s Day, 3rd Monday in February

d. Memorial Day, Last Monday in May

e. Independence Day, July 4th

f. Labor Day, 1st Monday in September

g. Columbus Day, 2nd Monday in October

h. Veteran’s Day, November 11th

i. Thanksgiving Day, 4th Tuesday in November

j. Christmas Day, December 25th

2.1.1.2.3. Contractor Personnel shall not perform services or report to work on days the Government or installation is closed due to local determinations relating to safety conditions, inclement weather conditions, national emergencies, or energy conservation. During these periods of closure, the contractor personnel who are not designated as essential personnel shall not report for work nor shall they be compensated for those days.

2.1.1.3. Period of Performance. The anticipated period of performance of this requirement is a One

(1) Year Base Period, and Four (4) Twelve (12) Month Option Years. As such, the period of performance for this contract is as follows:

a. BASE YEAR – 07 AUGUST 2019 – 06 AUGUST 2020

b. OPTION YEAR 1 – 07 AUGUST 2020 – 06 AUGUST 2021

c. OPTION YEAR 2 – 07 AUGUST 2021 – 06 AUGUST 2022

d. OPTION YEAR 3 – 07 AUGUST 2022 – 06 AUGUST 2023

e. OPTION YEAR 4 – 07 AUGUST 2023 – 06 AUGUST 2024

2.1.1.4. Security and Workplace Safety. USAMRIID considers the safety of its employees, collaborators, volunteers, and neighbors to be a priority. USAMRIID’s security and safety is governed by a broad set of Federal, DoD and U.S. Army regulations and policies, which enables USAMRIID to safeguard materials and data in the laboratories as well as the personnel who work here. USAMRIID is frequently inspected by those regulating agencies, and successful completion of those inspections is required for USAMRIID to continue its operation. It is therefore critical that all employees, including Contractor employees, meet standards and maintain compliance with all regulations, policies, and procedures that have been instituted for their protection and the protection of others. Security, training, and other requirements may be subject to change based upon changes in regulations and policies, and the Contractor shall be immediately responsive to those changes.

2.1.1.4.1. The Contractor shall properly and adequately safeguard sensitive (FOR OFFICIAL USE ONLY) or classified Government materials in accordance with Department of Defense Directive (DoDD) 5230.09, DoDD 5200.1-R, DoDD 5200.1-PH AR 380-5, and AR 380-40. Work shall not be performed in classified areas unless appropriate clearances are received in accordance with DoDD 5220.22-M.

2.1.1.4.2. The Contractor shall comply with any local biological safety, security, or regulatory policies and procedures. The Contractor shall ensure that all Subcontractors comply with the aforementioned.

2.1.1.4.3. The Contractor employee must be able to maintain a safe workplace and comply with occupational health and safety rules and regulations and USAMRIID Standard Operating Procedures (SOPs).

2.1.1.4.4. The Contractor shall ensure full compliance with all OSHA requirements to include proper use of personal protective equipment for the work being performed.

2.2. NON-PERSONAL SERVICES:

2.2.1. This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contractor Officer (KO) immediately.

2.2.2. Contract personnel performing services under this contract shall be controlled, directed and supervised by contract management personnel only. The contractor’s management shall ensure that personnel properly comply with the performance standards outlined in the Quality Assurance Surveillance Plan (QASP). Contractor personnel will perform independent of and without the supervision of any Government official. Actions of contractor personnel may not be interpreted or implemented in any manner that results in any contractor personnel creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal personnel, providing direct personal services to any Federal personnel or otherwise violating the prohibitions set forth in FAR 7.5 entitled, “Inherently Government Functions” as well as in FAR 37.1, entitled, “Service Contracting.” The Government will control access to the facility and will perform the inspection and acceptance of the completed work.

2.3. CONTRACT MANAGEMENT:

2.3.1. Government Management. The Contracting Officer’s Representative (COR) and Alternate Contracting Officer’s Representative (ACOR) for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract. In the event that the COR is not available, the ACOR will assume the COR’s responsibilities.

2.3.2. Contractor Management. The contractor shall designate a single Program Manager (PM) to be the contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract. The PM shall demonstrate capability in the overall management of complex tasks, and strong team building skills.

2.3.2.1. The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

2.3.2.2. The Contractor shall designate a Program Manager (PM). The Contractor’s designated PM shall serve as the single point-of-contact for addressing contract issues, quality issues, and overall Contractor performance. This may include coordination with the KO, Contract Specialist, and the COR to resolve any issues that may arise, trends relating to the contract or proposed changes, or modifications to the contract.

2.3.2.2.1. The Contractor Program Manager shall be responsible for the performance of the work and daily operations of Contractor as applicable. The name of this person and an alternate (who shall act for the Contractor when the manager is absent) shall be designated in writing to the KO.

The Manager or alternate shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract. The Manager or alternate shall be available (in-person or virtually) as required.

2.3.2.3. Contract Management Plan (CMP) (Deliverable #1). The Contractor shall develop and provide a Contract Management Plan (CMP) with their proposal. The CMP shall include a detailed staffing plan which includes a listing of personnel utilizing a job description to describe the position that will be required to meet the objectives of the Performance Work Statement (PWS).

2.3.2.4. Quality Control Plan (QCP) (Deliverable #2). The Contractor shall provide a DRAFT QCP with their proposal and a FINAL QCP no later than Fifteen (15) days after contract award.

The Contractor shall prepare and adhere to a QCP describing how the Contractor intends to manage the contracts to achieve the established standards as set forth in the PWS Summary Matrix and the Contractor’s QCP.

2.3.3. Subcontract Management. The Contractor shall be responsible for the management and performance of Subcontractors during this contract. Contractors may add Subcontractors to their team after notification and approval from the Procuring Contracting Officer (PCO) and COR.

Cross Teaming shall be permitted.

2.3.4. Requirement to Fill Vacant Positions. The contractor shall fill vacant positions within Forty- Five (45) business days. If contractor positions are vacant for more Forty-Five (45) days, the Contracting Officer (KO) shall immediately be notified in writing.

2.3.5. Key Personnel. There are no Key Personnel for this project. The Contractor is expected to assign personnel for this requirement with a strong background in this work.

2.4. REPORTS:

2.4.1. Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable Federal Acquisition Regulation (FAR) clause 52.227-14, Rights in Data. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

2.4.1.1. Organizational Conflict of Interest (OCI) (Deliverable #3, Exhibit 1). This contract will be used to procure U.S. Army Medical Research and Material Command (USAMRMC) OCI Category Two (2) – Program and/or Administrative Support, which falls within the scope of the PWS. The contractor shall provide an OCI certification with their proposal.

2.4.1.2. Non-Disclosure Statement (NDS) (Deliverable #4, Exhibit 2). The contractor shall ensure that all contractor personnel are advised of nondisclosure policies as well as restrictions from communicating official business to media outlets. The contractor shall provide signed non-disclosure statements from each personnel assigned, prior to performing any services.

2.4.1.3. Monthly Status Reports (Deliverable #5). The contractor shall provide monthly reports detailing all work completed within Seven (7) calendar days after each end of month. The report shall include, but not limited to a detailed list of all data deliveries completed during the previous month, all documentation scheduled for delivery during the next Two (2) months, those items which required Government approval during the previous month, and whether approval has been given or is still pending, a list of documentation which was due and not delivered, and the status of delinquent data deliveries to include impact statements for each delinquency. It shall be submitted with a transmittal letter that highlight major events in the reporting period. The report shall also include details outlining the expenditures and billings to date, projected expenditures and billings, progress, status, inventories, and any problems/issues encountered as applicable. The format for the report shall be agreed upon by the Government and Contractor.

2.4.1.4. Post Award Conference – Including Quality Control Reporting (Deliverable #6). The Contractor shall attend a post award conference (kick-off meeting) in coordination with the Government within Five (5) business days after contract award. The Contractor shall meet with the Government to present an overview of their approach and establish schedules, procedures, and points of contact necessary to conduct the tasks outlined herein. The meeting may be held via teleconference or in-person at a Government facility, as determined by the Government. The meeting should be coordinated and led by the Contractor Program Manager with additional Contractor employees in attendance as needed. The Contractor shall ensure that meeting materials are provided to Government participants Two (2) business days prior to the meeting.

2.4.1.5. Contractor Manpower Reporting (Deliverable #7). This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services.

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the AFPMB via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2018. Contractors may direct questions to the help desk at:

http://www.ecmra.mil/.

2.5. PERSONNEL TRAINING REQUIREMENTS

2.5.1. Completion of All Training Requirements (Deliverable #8). The contractor shall track and complete all initial and refresher trainings to maintain training compliance and readiness status.

The contractor shall submit certificates of completion for each contractor and subcontractor personnel working under this contract to the COR within Five (5) calendar days after completion of training.

2.5.1.1. Contractor Attendance at Government Training Opportunities. The Government may require contractor attendance at Government provided or Government sponsored training offered by the Research, Development and Acquisition Support Office, or as outlined in the current version http://www.ecmra.mil/ http://www.ecmra.mil/ of USAMRMC Command Policy Memorandums “US Army Medical Research and Materiel Command (USAMRMC) Decision Gate (DG) Training Requirements” and “Requirement for Training of Personnel Involved in Food and Drug Administration (FDA)-Regulated Activities”.

These training opportunities will be provided via web-based offerings, at on-site classroom settings or at local venues that will not otherwise incur travel expenses by the attendee. The Government determination for contractor attendance at one or more of the aforementioned training opportunities will be based on the applicability of the specific training opportunity to tasks being performed in this PWS and the above referenced USAMRMC Command Policy Memorandums. The COR will document all government training determinations made for each contractor personnel performing under this contract as well as training opportunity attendance/completion.

2.5.1.2. Anti-Terrorism (AT) Level 1 Training. All contractor personnel, including subcontractor personnel, requiring access to Army installations, facilities, or controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever applies. The contractor shall submit certificates of completion for each affected contractor personnel and subcontractor personnel to the COR (or to the contracting officer, if a COR is not assigned) with 5 calendar days after completion of training by all personnel and subcontractor personnel. AT Level I awareness training is available at https://atlevel1.dtic.mil.

2.5.1.3. iWATCH Training. The contractor and all associated subcontractors shall brief all personnel on the Fort Detrick iWATCH program, available on-line at http://www.detrick.army.mil/ready/iwatch.cfm. This locally developed on-line training will be used to inform contractor personnel on how to report suspicious activity. This training shall be completed with the results reported to the COR within Thirty (30) calendar days of contract award.

2.5.1.4. DoD Cyber Awareness Challenge Training. In order to enroll in this training, contractor personnel need to register on the Army Training Certification Tracking System (ATCTS) website.

Registration is required for all contractor personnel who require access to government information systems. All contractor personnel with access to a government information system must be registered in the ATCTS (Army Training Certification Tracking System) at commencement of services and must successfully complete the DoD Information Assurance Awareness training prior to access to the information system and then annually thereafter. This required non-residential training is on-line at https://ia.signal.army.mil/DoDIAA/default.asp. This training takes approximately one-hour to complete.

2.5.1.5. Operations Security Training (OPSEC) Training. Per Army Regulation (AR) 530-1, Operations Security, new contractor personnel shall complete Level I OPSEC Awareness Training within Thirty (30) days of reporting for duty. This non-residential training is required every 365 days, available on-line at http://cdsetrain.dtic.mil/opsec/index.htm. This training takes approximately 30 minutes to complete.

2.5.1.6. Information assurance/Information Technology (IA/IT training). All contractor personnel and associated sub-contractor personnel must complete the DoD IA Awareness Training before issuance of network access with a refresher training to be taken annually thereafter. All contractor personnel working in IA/IT functions must comply with DoD and Army training regulations DoD 8570.01, DoD 8570.01-M and AR 25-2 within six (6) months of appointment to IA/IT functions.

2.5.1.7. Threat Awareness and Response Program (TARP). Training applies to those contract https://atlevel1.dtic.mil/ http://www.detrick.army.mil/ready/iwatch.cfm https://ia.signal.army.mil/DoDIAA/default.asp http://cdsetrain.dtic.mil/opsec/index.htm personnel who have a security clearance. Applicable contractor shall complete this required non-residential training every 365 days, available on-line at https://www.lms.army.mil. It takes approximately two hours to complete.

2.5.1.8. Initial Security Orientation and Annual Security Refresher Training. Per requirements in Office of the Surgeon General (OTSG)/ Medical Command (MEDCOM) Policy Memo 14-004, Standardized Security Training darted 15 January 2014. All contractors shall complete the Initial Security Orientation within Thirty (30) days, and then must complete the Annual Security Refresher due every 365 days. This training is available on-line at https://www.lms.army.mil.

2.5.1.9. Army-Wide Network Security Focus (AWSNF) Training. Contractors shall complete this required non-residential training course to include (1) AWNSF-Phishing Awareness, (2) AWNSF- Personally Identifiable Information, (3) AWNSF-Portable Electronic Devices and Removable Storage Media, and (4) AWNSF-Safe Home Computing. Trainings are available on-line at https://iatraining.us.army.mil. All 4 courses shall be completed; this is a one-time only type training, and is required for the establishment of a government network account. These trainings take approximately one-hour to complete.

2.5.1.10. Combat Trafficking in Persons (CTIP) General Awareness Course. DoD mandates compliance, and has a zero tolerance policy regarding CTIP on all Government Contracts.

Contractor personnel are therefore required to complete this required training initially, and then once every 365 days. It is available on-line at https://www.lms.army.mil (AKO, then select ALMS) and takes approximately 30 minutes to complete.

2.5.1.11. Emergency Preparedness Response Program. Contractors shall complete this required non-residential training every three years, available on-line at Joint Knowledge Online (JKO) Home Page accessed via https://jko.jfcom.mil. It takes approximately one hour to complete.

2.5.1.12. Health Insurance Portability and Accountability Act (HIPAA) and Privacy Act Security Training. Contractor personnel shall complete this required non-residential course annually, available on-line at https://jkodirect.jten.mil. It takes approximately two-hours to complete.

2.5.2. Sexual Harassment/Assault Reponses and Prevention (SHARP) Contractor Training (Deliverable #9, Exhibit 3). This paragraph is added to incorporate reporting and training requirements and to reference the Office of the Surgeon General (OTSG)/Medical Command (MEDCOM) Policy Memo 16-033, dated 29 March 2016 as an attachment to the contract, Sexual Harassment Assault Response Prevention (SHARP) AKO ALMS instructions and the SHARP Self Study slides. This training is in accordance with USAMRAA Policy 17-01, SHARP FINAL DATED 19OCT2016 with attachments, and is applicable to all on-site contractors and contractor personnel supporting all Services type Contracts over the Simplified Acquisition Threshold (SAT), that are awarded by USAMRAA, and who are performing those services on-site in a Government facility or work space, leased or owned. Training may be obtained online for contractor personnel with an Army Knowledge On-line (AKO) account or it can be taken in person. In-person training through USAMRAA can be scheduled by contacting 301-619-8937 for class date/time and availability. If the personnel has an AKO account, they can access training online at Army AKO https://www.us.army.mil/.

2.5.2.1. In addition, All contractor personnel shall comply with OTSG/MEDCOM Policy Memo 16-033, Sexual Harassment/Assault Response and Prevention (SHARP) Program which states that https://www.lms.army.mil/ https://www.lms.army.mil/ https://iatraining.us.army.mil/ https://www.lms.army.mil/ https://jko.jfcom.mil/ https://jkodirect.jten.mil/ https://www.us.army.mil/

All allegations of sexual harassment and sexual assault shall be immediately addressed, no matter where they occur or who are involved. This includes all personnel working in Government facilities in support of contracts awarded by United States Army Medical Research Acquisition Activity (USAMRAA). Department of Defense and Department of the Army (DoDDA) civilian complaints of sexual harassment or sexual assault will be investigated and processed in accordance with the Equal Employment Opportunity (EEO) Program and AR 690-600. Contract personnel with knowledge of an incident of sexual harassment or assault will immediately report the incident to their employer and their employer will immediately report the incident to the Government’s Contracting Officer Representative (COR) or Contracting Officer.

2.6. OTHER DIRECT COSTS (ODC’S)

2.6.1. Other Direct Costs (ODC’s) (Deliverable #10). ODCs shall be billed on a cost reimbursable basis. ODCs are defined as purchase price of materials, travel, accommodations or other services plus applicable indirect costs and tax (if applicable). Fees will not be paid on ODCs or travel. Only General and Administrative (G&A) may be applied to ODC expenses. Upon Government approval, the Contractor can bill against ODCs for supplies and travel costs or other direct costs beyond that provided by the Government to allow their Contract employees to accomplish research purposes as defined by the contract.

2.6.1.1. The Contractor shall plan for four international trips a year (approximately Fourteen (14) days at a time). Trips will be from the Contractor’s base of operations to Uganda or Panama (Two

(2) trips per location), requiring three Contractor personnel for blood sample collection, processing and shipping, as well as flow cytometry experiments in country for each trip. All air travel will be booked via a US-based airline whenever possible as required by Federal Law.

SECTION 3: PERFORMANCE REQUIREMENTS

3.1. PERFORMANCE

3.1. The Contractor shall provide all necessary personnel required to perform services in support of the Warfighter Performance Group at the U.S. Army Aeromedical Research Laboratory (USAARL). The following section specifies the performance objectives and performance elements for the contract.

3.2. PERFORMANCE REQUIREMENTS SUMMARY (PRS) MATRIX

3.2.1. The contractor shall accomplish the assigned tasks by employing and utilizing qualified personnel with appropriate combinations of education, training, and experience. The contractor shall match personnel skills to the task with a minimum of under or over employment of resources.

PERFORMANCE

REQUIREMENT

PWS

PARA.

REF.

PERFORMANCE STANDARD

ACCEPTABLE

QUALITY

LEVEL (AQL)

METHOD OF

SURVEILLANCE

Identify a cohort of survivors 1.4.1.

Identify a Cohort of Survivors of MVD (Uganda) and VEE (Panama) and perform initial whole blood collection.

Blood samples will be delivered to the in-country host laboratory expeditiously following each collection.

100% Complete 100% Observation and Random Sampling

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Develop a database 1.4.2. Develop a Database to track survivors over time, and assess their immune status. 100% Complete 100% Observation and Random Sampling

Perform a Follow- Up 1.4.3.

Every six (±2) months perform follow-up collection of survivor’s sera and lymphocyte samples (whole blood), as in 1.4.1.

100% Complete 100% Observation and Random Sampling

Blood Processing Analysis

1.4.4. Assist USAMRIID and/or host country personnel in blood processing and analysis as needed. 100% Complete

100% Observation and Random

Sampling

Ship Blood and Blood Products 1.4.5.

Ship blood products to laboratories at USAMRIID, or to collaborators, as needed.

100% Complete 100% Observation and Random Sampling

3.3. Quality Assurance Surveillance Plan (Attachment #2). Every DoD contract awarded for services in excess of $2,500.00 shall contain a Quality Assurance Surveillance Plan (QASP) as discussed in the FAR 46, Government Contract Quality Assurance. A QASP is a plan that specify the particular services the COR will inspect and the method(s) used to complete that surveillance.

Each offeror shall digest the PWS in this RFP and offer a QASP associated therewith. The QASP shall be submitted as part of the offeror’s technical proposal. It will not be subjectively evaluated and rated. However, it may be discussed during the pre-award period for finalization prior to its inclusion in the awarded contract.

SECTION 4: SPECIAL CONTRACT REQUIREMENTS

4.1. Government Furnished Property. Any applicable Government Furnished Equipment determined to be necessary in the performance of the required services shall be identified at the time of contract award. All government furnished equipment shall be used only for direct support of the services requested in this PWS. The Contractor shall not install any software on government-furnished equipment, unless approved by USAMRIID and the KO prior to installation.

The Contractor shall maintain all Government-furnished information per Non-Disclosure Statement, regulations, and policies.

4.1.1. Access. The Government will provide and regulate access to Government buildings, facilities, and laboratories to enable Contractor employees to execute the PWS. Contractor employees shall maintain individual access badges furnished by the Government. The Government will make available desk, chairs, computer, fax machine, copying machine, scanning machine, printer, scientific equipment, and supplies necessary to perform the PWS while in the Laboratory setting. However, telephone, internet connectivity, and other supplies and equipment will not be provided and will be the sole responsibility of the Contractor.

4.1.1.1. The Contractor shall sign a Contractor Visitor Group Security Agreement to protect Government information involved in performance under this contract. The agreement shall outline responsibilities in the following areas: contractor security supervision; standard practice procedures; access, accountability, storage, and transmission of and other responsibilities, as required.

4.2. Contractor Furnished Property. If the contractor is stationed remotely, a government-furnished computer will not be provided. If the Contractor is stationed remotely, the information technology hardware and software shall comply with all relevant DoD Information Assurance requirements.

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4.3. Safety and Security. The contractor and all associated subcontractor personnel shall comply with applicable installation, facility, and area commander installation and facility access and local security policies and procedures. The contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by the installation, the Provost Marshal Office, the Director of Emergency Services, and/or the Security Office. The contractor workforce shall comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DoD, Headquarters Department of the Army (HQDA), and/or local policy. Should the Force Protection Condition (FPCON) level at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

4.3.1 Common Access Card (CAC). Before a CAC can be issued to contractor personnel, a favorably adjudicated National Agency Check with Inquiries (NACI), IAW Army Directive 2014- 05, Policy and Implementation Procedures for Common Access Card Credentialing and Installation Access for Uncleared Contractor, shall be obtained.

4.3.2. Non-CAC Eligible. Personnel of a Department of Defense contractor who is not eligible for a CAC credential, but still requires access to an Army installation or facility.

4.3.2.1. Contractors and all associated sub-contractor personnel shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05), applicable installation, facility and area commander installation/facility access and local security policies and procedures.

4.3.3. Personally Identifiable Information (PII), and Protected Health Information (PHI). The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data. The Contractor shall also ensure the confidentiality, integrity, and availability of Government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with Defense Federal Acquisition Regulation Supplement Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoD Directive 5400.11, “DoD Privacy Program,” May 8, 2007, and DoD 5400.11-R, “DoD Privacy Program,” May 14, 2007. The Contractor shall also comply with federal laws relating to freedom of information and records management. The Contractor shall comply with all requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L.

104-191), as implemented by the HIPAA Privacy and Security Rules codified at 45 CFR Parts 160 and 164, and as further implemented within the Military Health System by DoD 6025.18-R, "DoD Health Information Privacy Regulation," January 24, 2003, and DoD 8580.02-R, “DoD Health Information Security Regulation, July 12, 2007.

4.3.4. Force Protection Condition (FPCON). The Force Protection Conditions system has been approved by the Department of Defense to standardize the identification and recommended preventive actions and responses to terrorist threats against United States personnel and facilities.

Strict adherence to FPCON measures is required. A terrorist attack can take place at any time. The greater the perceived threat based on the intelligence received, the higher the awareness needs to be to prevent the loss of life.

4.3.4.1. When contractor personnel are considered mission essential, all contractor personnel are required to report for duty and remain on duty during declared emergencies or elevated FPCON

Page 12 of levels, unless otherwise directed by the contracting officer via the appropriate COR.

4.3.4.2. FPCON Normal. This condition applies when a general global threat of possible terrorist activity exists and warrants a routine security posture. At a minimum, access control will be conducted at all DOD installations and facilities.

4.3.4.3. FPCON Alpha. This applies when there is an increased general threat of possible terrorist activity against personnel or facilities, the nature and extent of which are unpredictable, and circumstances do not justify full implementation of FPCON Bravo measures. However, it may be necessary to implement certain measures from higher FPCONs as an additional deterrent or resulting from intelligence received. The measures in this FPCON must be capable of being maintained indefinitely.

4.3.4.4. FPCON Bravo. This applies when an increased or more predictable threat of terrorist activity exists. Sustaining Bravo measures for a prolonged period may affect operational capability and relationships with local authorities.

4.3.4.5. FPCON Charlie. This applies when an incident occurs or intelligence is received indicating that some form of terrorist action or targeting against personnel or facilities is likely. Prolonged implementation of Charlie measures may create hardship and affect the activities of the unit and its personnel.

4.3.4.6. FPCON Delta. This applies in the immediate area where a terrorist attack has occurred or when intelligence has been received that terrorist action against a specific location or person is imminent. FPCON Delta is usually declared as a localized condition. FPCON Delta measures are not intended to be sustained for an extended duration.

4.3.5. Mission Essential Personnel. When contractor personnel are considered mission essential, all contractor personnel are required to report for duty and remain on duty during declared emergencies or elevated FPCON levels unless otherwise directed by the contracting officer via the appropriate COR.

4.3.6. Classified Material. Generation, handling and storage of classified material. The contractor shall not generate, handle or store classified material for this contract.

4.3.7. Unclassified Contract Security Requirements. The contractor shall ensure all personnel performing under this contract have a favorable National Agency Check with written inquires (NACI), including a favorable completion of Federal Bureau of Investigation (FBI) fingerprint check, which the COR will coordinate with the United States Army Garrison (USAG) Fort Detrick Security office prior to performance start date. The security requirements shall be maintained for the life of the contract, and citizenship shall be verified by presenting an original birth certificate or a U.S. passport or the original Naturalization Certificate to the USAG Fort Detrick Security office at the time of in processing for all contract personnel assigned to the contract. In order to maintain the security requirements any derogatory information, to include law enforcement issues, mental health issues, or alcohol/drug related issues shall be reported to the COR, and USAG Fort Detrick Security Office.

4.4. Proprietary Information Assurance and Security. The contractor shall comply with Office of Management and Budget (OMB) Circular A-130, “Management of Federal Information

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Resources,” which requires Certification and Accreditation (C&A) of all federal information systems every three (3) years at a minimum or as changes that require re-accreditation occur. This C&A requirement ensures the effective safeguarding of sensitive but unclassified (SBU) data against unauthorized modification, disclosure, destruction, and denial of service, as directed by the DoD.

4.4.1. The contractor shall protect all data in the strictest confidence; prevent the unauthorized duplication, use and disclosure of information that is subject to the Privacy Act of 1974, Health Insurance Portability and Accountability Act (HIPAA) IAW applicable statutory, regulations, local policies and procedures.

4.4.2. All data received, processed, evaluated, loaded, and created as a result of this contract shall remain the sole property of the Government and shall be returned to the Government at the conclusion of the contract unless the contracting officer grants specific exception.

4.4.3. The contractor is prohibited from appropriation, disclosure, or unauthorized use of proprietary information that is acquired in the execution of this contract.

4.4.4. All products including files, software, and other information, which are created, produced or developed during the period of performance is the property of the Government and shall be returned unless the Government grants the contractor permission to retain the materials and products for continued development or publication.

SECTION 5 DELIVERABLES

5.1. The contractor shall provide the following deliverable as listed below.

ITEM PWS

REF.

TITLE DISTRO ELECTRONIC

COPIES

INITIAL

1 2.3.2.3. Contract Management Plan (CMP) KO, COR 2 2 2.3.2.4. Quality Control Plan (QCP) KO, COR 2 3 2.4.1.1. Organizational Conflict of Interest (OCI) KO, COR 2 4 2.4.1.2. Non-Disclosure Statement (NDS) KO, COR 2 5 2.4.1.3. Monthly Status Reports KO, COR 2

6 2.4.1.4. Post Award Conference – Including Quality Control Reporting KO, COR 2

7 2.4.1.6. Contractor Manpower Reporting KO, COR 2 8 2.5.1. Completion of all Training Requirements KO, COR 2

9 2.5.2. Sexual Harassment/Assault Reponses and Prevention (SHARP) Contractor Training KO, COR 2

10 2.6.1. Other Direct Costs (ODC’s) KO, COR 2

SECTION 6 APPLICABLE DIRECTIVES, REGULATIONS, AND POLICIES

6.1. Applicable Directives. Services provided under this contract must be conducted in accordance with all applicable state, Federal, DoD, and local laws, regulations, policies, and procedures that govern the conduct of work described herein. Federal regulations governing current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Quality System Regulation (QSR), and Human Subjects Protection are found in Title 21 Code of

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Federal Regulations (CFR). Additional Human Subjects Protection regulations are found in Title 45 CFR 46 and Title 32 CFR 219. Other applicable documents include FDA Guidance Documents, ICH Guidance Documents, and ISO guidance documents (e.g.: ISO 17025 and ISO 9000).

References for military regulations and policies governing regulated research may be found at:

https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.overview http://www.apd.army.mil/

6.1.1. The contractor shall comply with all documents listed below as mandatory and referenced under Section 3, Performance Requirements.

6.1.2. A list of mandatory and advisory policies, regulations, and other guidance can be found below. This list is not all inclusive. Other mandatory and advisory host nation guidance may be applicable to services provided OCONUS. Specific State and Host Nation requirements will be provided.

Regulation / Directive Description AR 5-5 Army Studies and Analyses AR 50-1 Biological Surety AR 280-5 DA Information Security Program AR 380-40 Policy for Safeguarding and Controlling Communications Security DoDD 1000.25 DoD Personnel Identity Protection (PIP) Program DoDD 5200.1-R DoD Information Security Program DoDD 5220.22-M Information Security Program DoDD 5400.11 DoD Privacy Program DoDD 5400.11-R DoD Privacy Program Regulation DoDD 6220 22-R Industrial Security Regulation

SECTION 7 DEFINITIONS AND ACRONYMS

7.1 Definitions

7.1.1. Contractor. 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.

7.1.2. Contractor Officer. A person with authority to enter into, administer, and/or terminate contracts, and make related determinations and findings on behalf of the government. The Contracting Officer is the only individual who can legally bind the government.

7.1.3. Contractor Officer’s Representative (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

7.1.4. Defective Service. A service output that does not meet the standard of performance associated with the Performance Work Statement.

7.1.5. Deliverable. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.overview http://www.apd.army.mil/

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7.1.6. Key Personnel. 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.

7.1.7. Physical Security. Actions that prevent the loss or damage of Government property.

7.1.8. Quality Assurance. The government procedures to verify that services being performed by the contractor are performed according to acceptable standards.

7.1.9. Quality Assurance Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

7.1.10. Quality Control. All necessary measures taken by the contractor to assure that the quality of an end product or service shall meet contract requirements.

7.1.11. Subcontractor. One that enters into a contract with a prime contractor. The Government does not have any contractual interactions with the subcontractor.

7.1.12. Work Day. The number of hours per day the contractor provides services IAW the Contract.

7.1.13. Work Week. Monday through Friday, unless specified otherwise.

7.2. Acronyms

Acronym Description ACA After Contract Award ACOR Alternate Contracting Officer’s Representative ADP/IT Automated Data Processing/Information Management AFARS Army Federal Acquisition Regulation Supplement AFPMB Armed Forces Pest Management Board AKO Army Knowledge Online ALMS Army Learning Management System AR Army Regulation ARS Agricultural Research Service ASDAT Aviation Survivability Development and Tactics AT Anti-Terrorism ATCTS Army Training Certification Tracking System AWSNF Army Wide Network Security Focus BSL Bio-Safety Level C&A Certification and Accreditation CAC Common Access Card CAP Contractor Acquired Property CFR Code of Federal Regulations CMR Contractor Manpower Reporting

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CONUS Continental United States COR Contracting Officer’s Representative CPARS Contract Performance Assessment Reporting System CT Computed Tomography CTIP Combatting Trafficking in Persons DA Department of the Army DFARS Defense Federal Acquisition Regulation Supplement DG Decision Gate DHA Defense Health Agency DHP Defense Health Department DoD Department Of Defense DoDD Department of Defense Directive DoDDA Department of Defense and Department of the Army DTIC Defense Technical Information Center

DUSD

EI&E

Deputy Under Secretary of Defense, Energy, Installations & Environment

DWFP Deployed Warfighter Protection EEO Equal Employment Opportunity EPA Environmental Protection Agency FAR Federal Acquisition Regulation FBI Federal Bureau of Investigation FDA Food and Drug Administration FPCON Force Protection Condition FY Fiscal Year GFE Government Furnished Equipment GFI Government Furnished Information HIPAA Health Insurance Portability and Accountability Act HTML Hypertext Markup Language HQDA Headquarters, Department of the Army IA/IT Information Assurance / Information Technology IASO Information Assurance Security Officer IAW In Accordance With IDIQ Indefinite Delivery / Indefinite Quantity ISO International Standards Organization IT Information Technology JKO Joint Knowledge Online JOC-5 Joint Program Committee 5 JTR Joint Travel Regulation KO Contracting Officer KS Contract Specialist MCSR Monthly Contract Status Report MEDCOM Medical Command MOMRP Military Operational Medicine Research Program NAC National Agency Check

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NACI National Agency Check with Inquiries

NCIC

National Crime Information Center Interstate Identification Index

NDS Non-Disclosure Statement NIPR Non-classified Internet Protocol Router NIST National Institute of Technology NLT Not Later Than OCI Organization Conflict of Interest OCONUS Outside the Continental United States ODC Other Direct Costs OHSP Occupational Health and Safety Program OMB Office of Management and Budget OPSEC Operations Security OSD Office of the Secretary of Defense OSHA Occupational Safety and Health Administration OTSG Office of the Surgeon General PAM Pamphlet PCO Procuring Contracting Officer PDF Portable Document Format PHI Protected Health Information PII Personally Identifiable Information PM Program Manager POC Point Of Contact PPE Personal Protective Equipment PWS Performance Work Statement QASP Quality Assurance Surveillance Plan QCP Quality Control Plan QSR Quality System Regulation RDT&E Research, Development, Training & Evaluation SBU Sensitive But Unclassified SHARP Sexual Harassment/Assault Response and Prevention SIPR Secure Internet Protocol Router SIPRNET Secure Internet Protocol Router Network SME Subject Matter Expert SOFA Status of Forces…