B08. Combined Synopsis_Solicitation - W81XWH22R0089.docx

W81XWH22R0089

Section SF 1449 - CONTINUATION SHEET

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial services prepared in accordance with FAR 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice and FAR 13, Simplified Acquisition Procedures. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is W81XWH22R0089. The solicitation is issued as a Request for Proposal (RFP). Provisions and clauses in effect through Federal Acquisition Circular 2022-06 are incorporated. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. The clause may be access in full text at: https://www.acquisition.gov/.

The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) has a requirement for the sorting of peripheral blood mononuclear cells (PBMCs) from Venezuelan Equine Encephalitis Virus (VEEV) survivors to discover and product monoclonal antibodies for assessment in in-vitro and in-vivo assays.

The U.S. Army Medical Research Acquisition Activity (USAMRAA) requests responses from qualified sources capable of providing services outlined in the below Performance Work Statement (PWS).

Novel Cell Sorting

FFP

Novel Cell Sorting & Antibody Development

1 Job = 1 Month of Services FOB: Destination

PSC CD: Q301

NET AMT

Other Direct (ODCs)

FFP

NET AMT

FFP

Novel Cell Sorting & Antibody Development

1 Job = 1 Month of Services

NET AMT

FFP

NET AMT

FFP

Novel Cell Sorting & Antibody Development

1 Job = 1 Month of Services

NET AMT

FFP

NET AMT

PWS

PERFORMANCE WORK STATEMENT (PWS)

FOR

VENEZUELAN EQUINE ENCEPHALITIS VIRUS CELL SORTING FOR MONOCLONAL ANTIBODY DISCOVERY

FOR

UNITED STATES ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES (USAMRIID)

SECTION 1 PURPOSE

1.1. Introduction

1.1.1. 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 Development Command (USAMRDC) at Fort Detrick, located in Frederick, MD.

1.2. Mission

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

1.3.1. Successful antibody discovery pipelines depend on: (1) the source sample used for antibody discovery, (2) the availability of high-quality antigens to identify and down-select candidate mAbs, and (3) a detailed understanding of the underlying biology of the target.

1.3.2. One of the critical factors missing from existing alphavirus antibody discovery efforts is high-quality antigen that accurately recapitulates the wild-type antigens present on the viral surface to support antibody identification and characterization. Alphavirus E1 and E2 heterodimers form a trimeric spike on the surface of the virus and a stable E1/E2 trimeric spike is essential to facilitate isolation of conformational mAbs targeting quaternary structural epitopes from survivor samples. Prior VEEV discovery efforts in particular have largely relied on panning with viral particles inactivated via chemical means or ultraviolet radiation, both of which may cause significant structural changes in the viral surface antigens and alter epitopes that bind to reactive antibodies. Thus, responders are expected to describe a technology or display platform that allows for antibody discovery using well-folded, native trimeric alphavirus spikes that have not been inactivated by chemical or physical means. Furthermore, a platform approach that facilitates the rapid assessment of antibody breadth of reactivity to a variety of VEEV subtypes and/or related alphavirus spikes would be a useful tool to leverage during the antibody down-selection process.

1.4. Scope

1.4.1. The primary objective of this requirement is to sort peripheral blood mononuclear cells (PBMCs) from Venezuelan Equine Encephalitis virus survivors to discover and produce monoclonal antibodies for assessment in in vitro and in vivo assays at USAMRIID.

1.5. Organizational Conflict of Interest (OCI) and Non-Disclosure Statement (NDS)

The FAR Part 9.5 prescribes responsibilities, general rules, and procedures for identifying, evaluating, and resolving Organizational Conflict of Interest (OCI), provides examples to assist Contracting Officers in applying these rules and procedures to individual contracting situations; and implements section 8141 of the 1989 Department of Defense Appropriation Act. The two (2) underlying principles which the FAR seeks to avoid are preventing the existence of conflicting roles that might bias a Contractor's judgment and preventing unfair competitive advantage. An unfair competitive advantage exists where a Contractor competing for award of any Federal contract possesses --

(1) Proprietary information that was obtained from a Government official without proper authorization; or

(2) Source selection information (as defined in FAR 2.101) that is relevant to the contract but is not available to all competitors, and such information would assist that Contractor in obtaining the contract.

The following subsections prescribe certain limitations on contracting as the means of avoiding, neutralizing or mitigating organizational conflicts of interest.

It is the Contractor’s responsibility to notify the Contracting Officer of any potential OCI. In the event that an OCI exists the Contractor shall propose a Mitigation Plan that shall be reviewed and accepted by the Contracting Officer prior to continuance of the work that presents an OCI. Should the proposed Mitigation Plan not be accepted by the Contracting Officer, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by the law or this contract.

Contractors shall sign a Non-Disclosure Agreement at the start of their performance on the contract.

If, under this contract, the Contractor will provide systems engineering and technical direction for a system, but does not have overall contractual responsibility for its development, integration, assembly, checkout or production, the Contractor shall not be awarded a subsequent contract to supply the system or any of its major components, or to act as consultant to a supplier of any system, subsystem, or major component utilized for or in connection with any item or other matter that is (directly or indirectly) the subject of the systems engineering and technical direction. The term of this prohibition shall endure for the entire period of this contract and for two (2) years thereafter.

If, under this contract, the Contractor will prepare and furnish complete specifications covering non-developmental items, to be used in a competitive acquisition, the Contractor shall not be permitted to furnish these items, either as a prime or subcontractor. The term of this prohibition shall endure for the entire period of this contract performance and for either two (2) years thereafter or the duration of the initial production contract whichever is longer. This rule shall not apply to Contractors who furnish specifications or data at Government request or to situations in which Contractors act as Government representatives to help Government agencies prepare, refine or coordinate specifications, provided this assistance is supervised and controlled by Government representatives.

If, under this contract, the Contractor will prepare or assist in preparing a work statement to be used in competitively acquiring a system or services, the Contractor shall not supply the system, its major components, or the service unless the Contractor is the sole source, the Contractor has participated in the development and design work, or more than one Contractor has been involved in preparing the work statement. The term of this prohibition shall endure for the length of this contract.

If, under this contract, the Contractor will provide technical evaluation of products or advisory and assistance services, the Contractor shall not provide such services if the services relate to the Contractor's own or a competitor's products or services unless proper safeguards are established to ensure objectivity.

If, under this contract, the Contractor gains access to proprietary or source selection information of other companies in performing advisory assistance services for the Government, the Contractor agrees to protect this information from unauthorized use or disclosure and to refrain from using the information for any purpose other than that for which it was furnished. A separate agreement shall be entered into between the Contractor and the company whose proprietary information is the subject of this restriction. A copy of this agreement shall be provided to the Contracting Officer.

The Contracting Officer has significant discretion as to the acceptability of any mitigation plan offered.

Contractors are encouraged to present their best strategy for mitigation of any potential OCI under this contract. Contractors shall submit a mitigation plan at the Contract level and update it as often as necessary throughout the life of the Contract.

The Contracting Officer (and when applicable the appropriate program office, acquisition manager, and legal counsel) will review the comparative analysis and, if provided, the Avoidance or Mitigation Plan, in accordance with the requirements of FAR Subpart 9.5 (Organizational Conflict of Interest) to determine whether award to that Offeror would be consistent with those requirements and review as necessary throughout the life of the contract. If it is unilaterally determined by the Contracting Officer that no OCI would arise or that the OCI Avoidance or Mitigation Plan adequately protects the interests of the government in the event of award to that Offeror, the Offeror will be determined eligible for award. If the Contracting Officer reasonably determines that a Contractor has not provided either a comparative analysis or avoidance/mitigation plan, or both, or that the analyses or plan provided is inadequate, sanctions including elimination from the award process, or termination of the related contract effort already awarded, as well as other appropriate sanctions will be considered.

If the Offeror/Contractor knows of no OCI in accepting work under this contract, it shall certify its OCI status and submit the certification with its proposal and any later award, if awarded the contract. The Contractor shall also obtain a similar certification of OCI status from all sub-Contractors, teaming partners or consultants prior to tasking any such party under this contract.

For breach of any of the above restrictions or for nondisclosure or misrepresentation of any relevant facts required to be disclosed concerning this contract, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by law or this contract.

Prior to a contract modification involving a change to the Performance Work Statement, or an increase in the level of effort or extension of the term of the contract, the Contractor shall submit any applicable organizational conflict of interest disclosure or an update of the previously submitted disclosure or representation.

1.5.1. OCI (Deliverable 1, Attachment 01). This Contract will be used to procure U.S. Army Medical Research and Development Command (USAMRDC) OCI Category Two (2) – Program and/or Administrative Support, which falls within the scope of the PWS. The contractor shall provide an OCI certification of OCI status from all sub-Contractors (if applicable), teaming partners or consultants prior to tasking any such party under the contract. In additions, the contractor shall ensure that all contractor personnel are advised of nondisclosure policies as well as restrictions from communicating official business to media outlets.

1.5.2. NDS (Deliverable 2, Attachment 02). The contractor shall sign the NDS and ensure that all staff including all employees, subcontractors, and consultants, assigned to or performing under the contract, execute, sign and adhere to the terms of the NDS. Assignment of staff who have not executed this statement or failure to adhere to this statement may constitute default on the part of the contractor. A completed NDS is required for each employee assigned under the contract, prior to performing any services.

SECTION 2 GENERAL REQUIREMENT

2.1. Place of Performance

Services shall be provided at the contractor’s facility.

2.2. Duty Hours

2.2.1. USAMRIID’s core hours of operation are generally Monday through Friday, 0900 to 1500, daily except U.S. Federal Holidays. Workers typically work eight (8) hours per day, 40 hours per week. All contractor personnel shall be available during core hours.

2.2.2. 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 :

2.2.2.1. New Year’s Day, 1 January

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

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

2.2.2.4. Memorial Day, last Monday in May

2.2.2.5. Juneteenth, 19 June

2.2.2.5. Independence Day, 4 July

2.2.2.6. Labor Day, 1st Monday in September

2.2.2.7. Columbus Day, 2nd Monday in October

2.2.2.8. Veteran’s Day, 11 November

2.2.2.9. Thanksgiving Day, 4th Thursday in November

2.2.2.10. Christmas Day, 25 December

2.3. Non-Personal Services

2.3.1. 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.

2.3.2. Severable/Non-Severable Services. This PWS identifies services that are severable in nature.

2.3.3. Inherently Governmental Functions. This PWS has been reviewed and contains no services that are inherently governmental functions, as defined in FAR Part 2.1.

2.3.4. Acquisition Functions Closely Associated with Inherently Governmental Functions. This PWS has been reviewed and contains no acquisition functions closely associated with inherently government functions.

2.4. Contract Management

2.4.1. Government Management. The Contracting Officer’s Representative (COR) for this requirement 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 the contract.

2.4.2. The COR has specific technical, functional and oversight responsibilities. The assigned COR will serve as the official point of contact for coordination for the contract; approve or disapprove contractor invoices; review and accept or reject all contractor technical deliverables; monitor funds obligated and disbursed; conduct surveillance by uploading a monthly report in the Procurement Integrated Enterprise Environment (PIEE), Surveillance and Performance Monitoring (SPM); and, conduct other activities as may be specified by the COR appointment letter.

2.4.3. 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, 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. The PM shall demonstrate capability in the overall management of complex tasks, and strong team building skills. The name of the PM 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.

2.4.3.1. 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.

2.4.3.2. Contract Management Plan (CMP) (Deliverable 3). The Contractor shall revise its CMP as changes occur and submit revised CMP to the COR, for review and approval. The Contractor’s designated Program Manager shall serve as a single point of contact for addressing contract issues, quality issues, and overall contractor performance. Following Government approval of the revised plan, the plan shall be applied by the Contractor to manage, track and evaluate project or task performance.

2.4.3.3. Quality Control Plan (QCP) (Deliverable 4). After contract award, but not later than commencement of services, the contractor shall submit a QCP to the COR for review. The QCP shall, at minimum, include (a) a plan for providing services by appropriately qualified personnel that includes methodology for doing so; and (b) a plan to manage the contract to achieve the established standards as set forth in the PWS Summary Matrix and the Contractor’s QCP.

2.5. Reports

2.5.1. Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable “Rights in Data” clause (i.e. DFARS clause 252.227-7015). 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.

2.5.1.1. 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, the status of delinquent data deliveries to include impact statements for each delinquency, and all ODC expenses bill for the month. 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.

2.5.1.2. Quarterly Reports (Deliverable 6). The Contractor shall submit a quarterly report summarizing the work performed and completed throughout the quarter. The Contractor shall provide a copy of the quarterly report to the COR no later than 15 calendar days from the end date of each quarter. Quarters run on a calendar basis (March, June, September, and December).

2.5.1.3. Final Report (Deliverable 7). The Contractor shall provide a Final Report to the COR. The Contractor shall prepare the Final Report that shall include, but not be limited to, the results of the work performed and completed throughout the life of the contract and list of deliverables provided by the Contractor as part of the requirement. The report shall be submitted to the COR no later than 30 days after the end of the contract.

2.6. Other Direct Costs (ODC’S)

2.6.1. ODC’s shall be billed for all actual costs incurred and submitted on a monthly basis. Costs are defined as the purchase price of materials plus General and Administrative (G&A) charges or material and handling (M&H) charges.

2.6.2. All ODCs shall be fully supported in compliance with all competition requirements of the FAR PART 6.

2.6.3. All ODCs shall be reported as stated in the Monthly Status Report (Deliverable 5). See Section 2.4.1.1.

2.6.4. Estimated ODCs are up to the maximum value specified in Section B material expenses as approved and allowed in the terms of the contract.

2.7. Maintain Safety, Security, and Biosecurity Standards

2.7.1. General

Established in 1969, USAMRIID has decades of experience operating containment laboratories and has provided extensive training and consultation to other agencies setting up their own facilities. USAMRIID considers the safety of its employees, neighbors, and the surrounding community its number one priority. USAMRIID’s Biosecurity Program is governed by a broad set of Federal, DoD and US Army regulations and policies. The program, which enables USAMRIID to safeguard both the biological materials we use in our laboratories and the personnel who work here, consists of the four key areas of biological safety, physical security, personnel reliability, and agent accountability.

There are four levels of biological containment, ranging from BSL-1, the lowest, to BSL-4, the highest. BSL-1 would be comparable to an open bench laboratory found in a school classroom—no special precautions would be needed. At BSL-2, USAMRIID employees wear laboratory coats and observe other basic precautions. For BSL-3 work, personnel are required to wear approved PPE and comply with established biosafety standards. BSL-4 is the highest level of containment, and employees wear positive-pressure encapsulating suits and breathe filtered air as they work. Other personal protective equipment may be required, depending on the tasks to be performed and biosafety level.

In addition, a combination of rigorous training, meticulous procedures, tight security, carefully designed structures, and elaborate and redundant operating systems is in place to protect laboratory workers. These measures also ensure the safety of those outside the suites. Investigators working in USAMRIID laboratories are and must be highly trained to follow and comply with established safety, biosafety and biosecurity procedures. Personnel may be required to demonstrate initial and continuous task proficiency with strict adherence to biosafety principles in order to conduct work in BSL-2 through BSL-4. Adherence to the USAMRIID Biosafety Program; Biosafety Plan, standard operating procedures, biocontainment suite specific manuals, biosafety training program and biosafety mentorship program will be ensured through a compliance program. As a part of this compliance program, all personnel are required to self-report any deviation to standard procedures and designated personnel may be required to observe work of others in the suites and document observations and adherence to the biosafety plan. Lack of adherence to any component of the Biosafety Program or lack of skill proficiency will be grounds for revocation of biocontainment access.

Investigators in the laboratories study amounts of infectious agents and the diseases they cause in order to develop vaccines, treatments and diagnostic tools. USAMRIID's research involving infectious agents is reviewed and approved by the Institutional Biosafety Committee, the Animal Care and Use Committee, the Portfolio Review Committee, and other internal and external reviewers as applicable. No studies can take place without careful examination of all protocols to assess risks.

Personnel with the appropriate, government-required training and certification to operate in biocontainment environments are not readily available in the commercial marketplace and are unique to the extremely small number of laboratories worldwide that perform research in BSL-3 and BSL-4. As described above, approved work in biocontainment suites and using BSAT requires stringent background checks, health screening, enrollment in specialized reliability programs, and mentored hands-on training. It takes an extensive amount of time and government effort for a new staff member to become fully trained and operational, and there is inherent risk that new personnel will not meet the stringent security and reliability program requirements.

2.7.2. Security

USAMRIID considers the safety of its employees, neighbors, and the surrounding community its number one priority. USAMRIID’s Biosecurity Program is governed by a broad set of Federal, DoD and US Army regulations and policies, which enables USAMRIID to safeguard both the biological materials used 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.

The Contractor shall not employ, or continue employment, of persons for work on this contract, if such employee is identified to the Contractor by the KO as a potential threat to the health, safety, security, general well-being, or operational mission of the installation or its population. All Contractor employees shall be screened before hiring for active participation in any group that opposes the use of animals in research; such candidates shall not be selected for work on this PWS (all contract employees shall support the humane use of laboratory animals in research). In addition, if it becomes known that an employee is an active member of any group that opposes animal research or in any other way demonstrates a desire to compromise the security or the mission of the Institute, the Contractor employee shall be removed from this requirement immediately.

2.7.3. Security Requirements

The Contractor shall protect all For Official Use Only (FOUO) and unclassified information involved in the performance under this contract.

2.7.4. Installation Access Requirements

2.7.4.1. All visitors must enter through the Nallin Gate which is open 24 hours per day, seven days per week. Contractors are to provide proof of identification to the Fort Detrick security staff at the Visitor Center located at the Nallin Gate. A Criminal History Check will be conducted on all Contractor and subcontractor employees requiring base access. Acceptable forms of Government issued identification include a passport or Driver’s License that complies with the REAL ID ACT. Non-U.S. citizens visiting Fort Detrick will require a Federal employee escort onto the Base. Non-U.S. Citizens visiting or working at USAMRIID will require MRDC approval. Vehicles entering the Base will be searched before being allowed to enter the Base. In addition to your vehicle, the trunk, boxes, bags, or other items located in the vehicle is subject to search. Federal law prohibits the following items on Federal property: firearms, explosives, archery equipment, dangerous weapons, knives and blades over 2 ½ inches, alcoholic beverages and open containers of alcohol. No photographs may be taken while on Fort Derick. Cell phones may be used while driving only if hands free.

2.7.4.2. The Contractor and all associated subcontractors’ employees shall comply with applicable installation, facility, and area commander installation and facility access and local security policies and procedures provided by the Government representative. The Contractor shall return all issued U.S. Government Common Access Cards, installation badges, access badges to the COR when the Contract is completed or when a Contractor employee no longer requires access to the installation and facility as defined in the contract.

2.7.4.3. Force Protection Condition (FPCON) impact on work levels. The Contractor employees must comply with all personal identity verification requirements as directed by DoD, and local policy. In addition to the changes otherwise authorized by the changes clauses of this contract, should the FPCON change, the Government may require changes in Contractor security matters or process. IAW DoDI 2000.16, the FPCON is defined as follows:

2.7.4.3.1. FPCON ALPHA. This condition applies when there is a general threat of possible terrorist activity against personnel and 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 THREATCONS resulting from intelligence received or as a deterrent. The measures in this THREATCON must be capable of being maintained indefinitely.

2.7.4.3.2. FPCON BRAVO. This condition applies when an increased and more predictable threat of terrorist activity exists. The measures in this THREATCON must be capable of being maintained for weeks without causing undue hardship, affecting operational capability, and aggravating relations with local authorities.

2.7.4.3.3. FPCON CHARLIE. This condition applies when an incident occurs or intelligence received indicating some form of terrorist action against personnel and facilities is imminent. Implementation of measures in this THREATCON for more than a short period probably will create hardship and affect the peacetime activities of the unit and its personnel.

2.7.4.3.4. FPCON DELTA. This condition 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 likely. Normally, this THREATCON is declared as a localized condition.

2.7.5. Security Clearance Requirements – NOT APPLICABLE

2.7.5.1. The Contractor shall acquire the necessary security clearances. A facility clearance through a servicing Defense Security Service is required to be maintained and updated when applicable as established on the DD Form 254 (NOT APPLICABLE). The Contractor shall initiate the necessary personnel background checks for successful processing of contract employees through the USAMRIID Personnel Security Office. USAMRIID is a restricted area and the minimum personnel background investigations will be a T1, previously known as a National Agency Check with Inquiries (NACI). A NACI is also acceptable provided the individual has not had a 24 month break-in-service from the previous Government employment. It is anticipated that the highest clearance required will be SECRET. A T3 or T5 investigation may also be required for other positions as required depending on the duties performed.

2.7.5.2. Contractor employees enrolled in the Biological Personnel Reliability Program (BPRP) will require a T3 investigation (NACLC/ANACI is acceptable if completed within 5 years prior to enrollment). A favorably adjudicated SECRET security clearance eligibility, with no access to classified, is required. Periodic reinvestigations will be completed every 5 years. An unfavorably adjudicated reinvestigation that renders an individual ineligible for a security clearance will result in termination from the BPRP. The Contractor will ensure personnel enrolled in the BPRP are affiliated with the Contract Company in the Defense Information System for Security (DISS) to prevent loss of eligibility.

2.7.5.3. All background investigation forms and fingerprints must be completed prior to start. “IAW DEPARTMENT OF DEFENSE (DOD) MANUAL 1000.13, VOLUME 1, DOD IDENTIFICATION (ID) CARDS: ID CARD LIFE-CYCLE, JANUARY 23, 2014 Army Regulation 380-67, Personnel Security Program, and the Department of Army, Trusted Associate Sponsorship System (TASS), Standard Operating Procedure and Army TASS policy, Contractor must have a valid Tier 1 or DoD-equivalent background investigation submitted to OPM and the completion of an FBI fingerprint check with the return of favorable results to obtain a Common Access Card (CAC) and begin work. If the background check is adjudicated and returned with unfavorably information found, the Contractor’s Common Access Card (CAC) will be revoked and the Contractor will not be permitted to work. Further, an unfavorable fingerprint result will require the completion of the required investigation or a favorable suitability determination by the security officer prior to the Contractor being on boarded.

2.7.5.4. USAMRIID will submit the investigation through the Personnel Security Investigations Portal (PSIP). Once the Security Office reviews the Questionnaire for Non-sensitive Positions (SF85) or Questionnaire for National Security Positions (SF86), the investigation is scheduled at the Office of Personnel Management (OPM), and favorable fingerprints have been obtained, the Security Office will notify the Contracting Agency and USAMRIID Human Resources that they are cleared for an EOD date.

2.7.5.5. Any delays in recruitment caused by security issues are the responsibility of the Contractor unless an exception is authorized by the KO. The security requirements for other USAMRDC laboratories or customers will be specified on each individual task order. Any additional security requirements will be provided in the individual task order PWS. The appropriate security clearance forms will be provided to the Contractor IAW FAR Clause 52.204-2 in Section I.

2.7.5.6. In order to retain a CAC, Contractor’s Site Security Manager will be required to complete the AHRC TASS Form, Contractor CAC Reverification/Retrieval Form every 180 days. The Contractor will be provided the form and must comply with completing the form within the specified timeframe (typically a 2-week timeframe). Failure to complete this form will result in the CAC being revoked.

2.7.6. Requirements for BPRP Enrollment

2.7.6.1. Contractors needing unescorted access to BSAT at USAMRIID will enroll in Army’s BPRP.

2.7.6.2. When entering a Federal Select Agent Program (FSAP)-registered space at the USAMRIID of Fort Detrick, MD, the Contractor shall comply with all applicable Federal, DoD, and Army regulations governing BSAT. In addition, the Contractor shall comply with any local biosecurity policies and procedures. The Contractor shall ensure that all subcontractors comply with the aforementioned.

2.7.6.3. Contractor personnel assigned to BPRP duty positions will enroll in the Army BPRP subject to occupational health screening at no additional cost to the government. The Contractor shall provide records of employment, medical and urinalysis required for BPRP screening to the Surety Officer IAW local procedures. The Contractor will provide drug abuse screening services consistent with AR 190-17 and AR 600-85 IAW local procedures at no additional cost to the government.

2.7.6.4. Personnel provided under the contract must successfully obtain and maintain a Department of Health and Human Services Security Risk Assessment (SRA), have a T3 investigation (as identified in para. 2.6.5), and shall be medically qualified to wear appropriate respiratory protection and personal protective equipment (PPE). When required, as a part of services being provided, Contractor personnel are eligible to receive vaccinations. Potentially Disqualifying Information (PDI) discovered during the contract period will be provided to the Surety Officer IAW local procedures.

2.7.6.5. Biosecurity Training Requirements for BPRP-Enrolled Personnel.

Contractor employees are required to complete biosecurity training(s) relative to his/her position or function and report any infractions of biosecurity procedures to the Contracting Officer Representative (COR) immediately. Training is designed to safeguard both the biological materials used in the laboratories (BSL-2 through BSL-4) and the personnel who work within and outside the laboratories. Training will cover, at a minimum, safety/biosafety, security (including security awareness), select agent and toxin training, incident response, insider threat and BPRP training.

2.7.6.6. Government Furnished Services

Contract employees in the Army’s BPRP are authorized medical examinations related to screening for infectious diseases and toxins at the BPRP Barquist Army Health Clinic, vaccinations as recommended, and personal protective equipment (PPE) as required.

2.7.6.7. Contractor Furnished Services

The Contractor shall provide drug screening services IAW AR 190-17 and AR 600-85 and provide testing results to the Surety Officer IAW local procedures at no additional cost to the government. If USAMRIID or Army Occupational Health and Safety personnel determine the need for a contract employee to be screened for infectious agents and toxins, the contract employee will obtain the required test(s), as determined by USAMRIID, in consultation with that employee's medical or Occupational Health provider.

2.7.7. Requirements for Escorted Entry to Federal Select Agent Program (FSAP)-Registered Spaces (Visitor)

Contractors not routinely working in FSAP registered areas will not be enrolled in the BPRP and will comply with USAMRIID Pamphlet 190-17-7, Escorted Entry into FSAP-Registered Areas within USAMRIID.

2.7.7.1. Biosecurity Training Requirements Escorted Entry to FSAP-Registered Space (Visitor).

Contractor employees are required to complete biosecurity training(s) relative to his/her position or function and report any infractions of biosecurity procedures to the Contracting Officer Representative (COR)/TPOC immediately. Training is designed to safeguard both the biological materials used in the laboratories (BSL-2 through BSL-4) and the personnel who work within and outside the laboratories. Training will cover, at a minimum, safety/biosafety, security (including security awareness), and incident response.

2.7.7.2. Services for Contractors Not Enrolled in BPRP (if applicable).

2.7.7.2.1. Government Furnished Services

USAMRIID will provide the contract employee a copy of the latest risk assessments and expected work conditions for the private Board-Certified Occupational Health Physician (BCOMP) to review. This will enable the private BCOMP to evaluate the health status of the Contractor for medical suitability for entry into USAMRIID’s containment laboratories and BSAT storage spaces.

2.7.7.2.2. Contractor Furnished Services (if applicable).

If USAMRIID or Army Occupational Health and Safety personnel determine the need for a contract employee to be screened for infectious agents or toxins, the contract employee will obtain the required test(s), as determined by USAMRIID, in consultation with that employee's medical or Occupational Health provider. This will be done at no additional cost to the government.

2.7.8. Workplace Safety

2.7.8.1. The Contractor employee must be able to maintain a safe workplace and comply with all occupational health and safety rules and regulations. Each Contractor employee is required to attend safety training(s) relative to his/her position and report any infractions of safety procedures to the COR/TPOC immediately.

2.7.8.2. At no additional cost to the government, the Contractor shall ensure all contract employees who work with laboratory animals have a required purified protein derivative (PPD) screening semi-annually. TB reactors shall undergo whatever testing is currently acceptable by the USAMRIID Occupational Health and Safety staff (Quantiferon Gold blood testing and/or chest X-rays plus medical evaluation, or equivalent). If required by position or if determined as necessary through Occupational Health and Safety Medical, a respiratory fit test may be required. In addition, all contract employees at USAMRIID must comply with USAMRIID Occupational Health requirements.

2.7.8.3. At no additional cost to the government, vaccinations required to work in identified USAMRIID Veterinary Medical Division controlled areas shall be provided and updated as required by medical and/or CDC recommendations (whichever standard is more stringent) including tetanus, hepatitis B, MMR, two documented MMR vaccinations or proof of adequate titer is required as it is medically considered to provide lifelong immunity, rabies (or proof of adequate titer based on CDC/industry standards), and annual flu vaccine. Contractor will provide dates when vaccinations or titers (rabies or MMR) were performed.

2.7.9. Foreign Nationals Requirements

A foreign national can only be hired if they have a special skill that a US Citizen cannot be found to perform. The investigation must be completed in its entirety before unescorted access to the facility is granted. Government computer access may be approved, but the process has to be approved by the Fort Detrick Designated Approving Authority. Foreign Nationals with requirements for access to Tier 1 BSAT will be processed for a Limited Access Authorization.

2.7.10. Requirements for Controlled Substances PRP (CS-PRP) Enrollment.

2.7.10.1. Contractors needing unaccompanied access to controlled medical substances at USAMRIID will enroll in the CS-PRP.

2.7.10.2. When accessing controlled medical substances at the USAMRIID at Fort Detrick, MD, the Contractor shall comply with all applicable Federal, DoD, and Army regulations governing the use of controlled medical substances. In addition, the Contractor shall comply with any local controlled medical substances policies and procedures. The Contractor shall ensure that all subcontractors comply with the aforementioned.

2.7.10.3. Contractor personnel assigned to CS-PRP duty positions will enroll in the USAMRIID CS-PRP subject to medical screening provided by the government. The Contractor shall provide personnel, medical and urinalysis records required for the individual’s CS-PRP screening to the CS-PRP Surety Officer IAW local procedures. The Contractor will provide drug abuse screening services consistent with AR 600-85 IAW local procedures at no additional cost to the government.

2.7.10.4. Personnel provided under the contract must be assessed as qualified through personnel, security, medical, and law enforcement records checks and drug test information. The Certifying Official will interview the incumbent to appraise character, judgment, reliability, attitude, emotional and mental maturity, and sense of responsibility before enrollment into the CS-PRP. Personnel exhibiting financial irresponsibility will not be enrolled into the CS-PRP.

2.7.10.5. Contractor personnel requiring access to controlled substances must complete a USAMRIID Consent to Release Information and a Request for Background Check for Personnel Working with Controlled Substances Forms. These forms are provided by the Personnel Security Office and submitted to the Criminal Investigation Division (CID), Fort Meade for processing and approval.

2.7.10.6. Government Furnished Services

A contract employee in the CS-PRP is authorized medical consult or screening regarding medical treatments and/or medications that may affect their CS-PRP status.

2.7.10.7. Contractor Furnished Services

The Contractor shall provide drug screening services IAW AR 600-85 at no additional cost to the government and provide testing results to the CS-PRP Surety Officer IAW local procedures. If the Certifying Official or Competent Medical Authority determine the need for the incumbent to be screened for potential CS-PRP disqualifying factors, the contract employee will obtain the required screening, as determined by USAMRIID, in consultation with that incumbent’s medical or Occupational Health provider at no additional cost to the government. The Contractor will provide the incumbent’s performance evaluation and/or personnel records when requested by the Certifying Official for periodic review for disciplinary actions or other patterns of behavior that may indicate unreliability.

References (Available for review in USAMRIID library):

1. 7 CFR part 331, Possession, Use and Transfer of Biological Select Agents and Toxins

2. 9 CFR part 121, Possession, Use and Transfer of Biological Select Agents and Toxins

3. 29 CFR part 1910, OSHA General Industry Regulations

4. 42 CFR part 73. Select Agents and Toxins

5. Department of Defense Instruction (DODI) 5210.89, Minimum Security Standards for Safeguarding Biological Select Agents and Toxins

6. AR 40-400 Patient Administration

7. AR 190-17, Biological Select Agents and Toxins Security Program

8. AR 190-51, Security of Unclassified Army Resources (Sensitive and Nonsensitive)

9. AR 190-13, The Army Physical Security Program

10. AR 385-10, The Army Safety Program

11. AR 600-85, Army Substance Abuse Program

12. DA Pamphlet 385-69, Safety Standards for Microbiological and Biomedical Laboratories

13. MEDCOM Regulation 40-55, Guidance on Occupational Health Practices for the Evaluation and Control of Occupational Exposures to Biological Select Agents and Toxins (BSAT)

14. USAMRIID Regulation 385-69, Biological Safety Program

15. USAMRIID Pamphlet 190-17-7, Escorted Entry into FSAP-Registered Areas Within USAMRIID

16. USAMRIID Pamphlet 190-17-4, Biological Select Agents and Toxins Security Program

2.7.11. Network Security

2.7.11.1. Contractor personnel requiring access to DoD networks to perform work under this contract must have a NACI or an open, pending investigation prior to commencement of work. If the Contractor has a pending investigation, a copy of this investigation must be presented to the USAMRIID Personnel Security Manager at the time of in-processing for review and must contain no unfavorable information. The Contractor must maintain this level of security for the life of the contract. Citizenship will be verified by presenting an original birth certificate or a valid US Passport or the original Naturalization certificate to the USAMRIID Personnel Security Manager at the time of in-processing for all Contractor personnel assigned to the contract. Any derogatory information, to include law enforcement issues, mental health issues, or alcohol/drug related issues must be reported to the USAMRIID Personnel Security Manager.

2.7.11.2. Contractor personnel shall use only Government-provided computer equipment; and shall follow all applicable statutes, regulations and policies governing DoD, MEDCOM, USAMRMC, and USAMRIID cyber security and information system assets. Personnel must provide proof of applicable training and certifications to include annual Cyber Awareness training. This training must be documented in the Army Training and Certification Tracking System (ATCTS) unless otherwise authorized by applicable policies. DoD Information System, IT service, and IT product acquisition or development must also adhere to applicable policies as described below:

2.7.11.3. It is DoD policy that Cybersecurity requirements shall be identified and included in the design, acquisition, installation, operation, upgrade, or replacement of all DoD information systems. This includes systems and processes developed within the Defense Acquisition System; systems and processes developed at private expense; outsourced business processes supported by private sector information systems; and outsourced information technologies. Information technology services provided under this contract must comply with statutory and regulatory IA policy. The source documents for this policy are (available in the USAMRIID library for review):

1. The National Security Act of 1947

2. Title 40/Clinger-Cohen Act

3. Executive Order 12333, “United States Intelligence Activities,”

4. National Security Presidential Directive-54/Homeland Security Presidential Directive-23

5. Subchapter III of chapter 35 of Title 44, United States Code (also known as the…