W81XWH20R0046.pdf

PDF 692 KB Posted Jul 21, 2020

Attached to: TRANSMISSION ELECTRON MICROSCOPE
Solicitation number: W81XWH20R0046
Issued by: Department of the Army Medical Command

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Written by GovTribe AI · Dec 27, 2023

This is a combined synopsis/solicitation issued by the Department of the Army Medical Command seeking proposals for a transmission electron microscope and related services. The solicitation requests a core instrument with a 200kV electron source, autoloader, direct detection camera over 4000x4000 pixels, and maintenance for one base year and four optional years. Training and site preparation are also required. Proposals are due as a request for proposal with no written solicitation to be issued. Pricing will be firm fixed price. The period of performance is one base year for maintenance with four optional years. The place of performance is the Walter Reed Army Institute of Research in Silver Spring, Maryland.

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W81XWH20R0046

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 13.5, Simplified

Procedures For Certain Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; Proposals are being requested and a written solicitation will not be issued. The solicitation number is W81XWH20R0046. The solicitation is issued as a Request for Proposal (RFP).

Provisions and clauses in effect through Federal Acquisition Circular 2020-07 are incorporated. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses https://acquisition.gov/far/index.html and http://www.acq.osd.mil/dpap/sitemap.html. The NAICS code is 334516, with a small business size standard of 1,000 employees.

Offerors shall submit a proposal in response to the requirements of the United States Army Medical Research

Acquisition Activity (USAMRAA) in support of the Walter Reed Army Institute of Research (WRAIR).

USAMRAA requests responses from qualified sources capable of equipment that can meet the Government’s requirement.

SECTION B

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Each

TRANSMISSION ELECTRON MICROSCOPE

FFP

FOB: Destination

NET AMT

0002 1 Each

SITE PREPARATION

Provide a time table for site preparations.

https://acquisition.gov/far/index.html http://www.acq.osd.mil/dpap/sitemap.html

0003 12 Months

MAINTENANCE

1001 12 Months

OPTION MAINTENANCE

2001 12 Months

OPTION MAINTENANCE

3001 12 Months

OPTION MAINTENANCE

4001 12 Months

OPTION MAINTENANCE

SECTION C

1. PURPOSE AND BACKGROUND

The ability to visualize biological phenomenon provides a level of understanding that enables conceptual, technical, and practical breakthroughs. High resolution biological information has enabled the testing, identification, and development of therapeutic interventions. Cryo-EM is a biophysical technique that can be used to determine the structure of biological macromolecules and assemblies. Historically, its applicability for high resolution structure determination and therapeutic development has been limited to large assemblies and did not provide high resolution data. The Cryo-EM capability would also complement the current X-ray crystallography capabilities within MHRP, and Bacterial Diseases Branch by providing structural information on dynamic molecules, membrane proteins, or large complexes including virus particles that are recalcitrant to crystallization. The Cryo-TEM microscope will be utilized by multiple branches within WRAIR including the Emerging Infectious Diseases, Viral Diseases, Bacterial

Disease, Experimental Therapeutics, Malaria, and Veterinary Pathology branches, and would be available for additional research within MRMC. A critical and necessary aspect of every vaccine study that MHRP performs is the measurement of binding and functional antibodies. The initial studies will utilize the microscope capabilities strictly to study COVID-19-related projects targeting the development of vaccines, diagnostic tests, small molecule inhibitors, and monoclonal antibody therapeutics. Future studies related to WRAIR efforts include structural studies of HIV-1 Env in complex with antibodies, and Zika virus and other flaviviruses in complex with neutralizing and binding antibodies. This work serves to facilitate increased speed and accuracy in the development of vaccines and therapeutics for the warfighter.

2. SCOPE

The scope of the requirement is to obtain a state-of-the-art Cryo transmission electron microscopy (TEM). This instrument shall be purchased, installed and set-up within a 6 to 9 month period. The requirement includes the procurement of the instrument including the core instrument, and a high performance direct electron detector. The requirement further includes the initial training for WRAIR personnel in the operation of the equipment and an extended maintenance and emergency support service package.

3. PERIOD OF PERFORMANCE

The periods of performance for this contract are as follows:

Base period 12 months

Option Period 1 One year from end of base period

Option Period 2 One year from end of Y1

Option Period 3 One year from end of Y2

Option Period 4 One year from end of Y3

4. WORK SCHEDULE AND LOCATION

4.1. Work Location

503 Robert Grant Avenue

Silver Spring, MD 20910.

4.1.1. Working During Emergency Situations

Contractor shall not report to work on those days the Government or installation is closed due to safety conditions, inclement weather conditions, national emergencies, energy conservation or by direction of the

Installation Commander for any other reason.

4.2. Federal Holidays

4.2.1. The contractor shall not perform services on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander

4.2.2. 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 that services shall not be performed

New Year’s Day

Birthday of Martin Luther King, Jr.

Washington’s Birthday

Memorial Day

Independence Day

Labor Day

Columbus Day

Veterans Day

Thanksgiving Day

Christmas Day

4.3. Post Closure

All non-mission essential contract employees shall not report to work on days the Government or installation is closed due to local determinations relating to safety conditions, inclement weather conditions, national emergencies, energy conservation. During these periods of closure, the mission essential contractor personnel shall report for work.

4.4. Work Schedule

The contractor shall provide support from 0745 to 1630 Eastern Time. The contractor shall provide contact information for scheduling support, and shall respond to support requests within 24 hours. Maintenance will be performed onsite, with repairs completed within 72 hours of initial request, unless otherwise agreed upon by

WRAIR and the contractor.

5. PERFORMANCE REQUIREMENTS

5.1. Specific Tasks / Requirements

5.1.1. Installation (Deliverable 1)

The contractor shall install a Cryo Transmission Electron Microscope and equipment that meet the requirements of the Essential Characteristics including:

o High-Tension Generator: Required for supply of power to the microscope.

o Uninterrupted power supply: Required to prevent any power surges or sudden loss of power.

o 200 kV Electron source: Required to allow high-resolution (< 3A) single particle analysis (SPA)

Cryo-EM structure determination.

o Automatic Aperture System: To rapidly adjust beam, remove high scatter angle electrons, or enable higher resolution data collection.

o Side-entry liquid nitrogen cooled stage with Autoloader: To allow sample loading and storage in the microscope with minimal effects on the microscope stability.

o Two condenser lenses: To control the beam intensity and parallel beam illumination.

o Data collection software: To allow rapid data collection including “movie-mode”.

o TEM automation capable: To ensure overnight data collection.

o Platform tilting capability during data collection i.e. “micro-ED” capable: To allow electron diffraction and data collection on microcrystals for structure determination.

o Cryo-Tomography capable, including software: To allow data collection on larger viral-like particles, and cells.

o Water chiller: To ensure adequate cooling of the microscope and detector.

o Field emission gun.

o Apparatus for loading autoloader.

Direct Detection Camera –To allow high-throughput data collection including movie mode, rapid image transfer. Detector size > 4000 x 4000 pixels i.e. >16 MPixels.

The installation process shall include a site survey and assessment for vibration, electrical, and magnetic interference with a plan of execution on how any identified interference will be remediated prior to installation. Any needed remediation related to vibration, electrical or magnetic interference shall be provided by the contractor with the assessment and oversight of WRAIR.

Vibration and electrical mitigation to be provided by the contractor.

Computer to control the camera.

Due to constraints in the room, the Offeror’s device, including any crane device used for installation/maintenance shall not be greater than 125 inches in height, 144 inches in width, and 204 inches in length. Any device that does not meet these specifications will not be able to fit in the allotted space, and therefore will not pass the size evaluation.

Enhancing Features:

Additional condenser lenses will provide improved microscope performance.

The microscope must have a side-entry autoloader. The ability to store sample cartridges within the autoloader without removal is preferred, i.e. not all samples need to be removed from the microscope at the one time.

An in-column Omega-style energy filter or energy filter equivalent to Omega-style slit width of 20 eV or greater, for imaging and spectroscopy, provides significant advantages for data collection, and is preferred.

Direct Detection Camera –The specifications of the proposed camera can be evaluated based on detector area, pixel size, DQE, lifetime DQE degradation, image transfer rate, and Internal frame rate value.

The presence of a phase plate to enable sample contrast is an advantage.

Ability to integrate and allow data acquisition with Serial-EM is an advantage.

Stage drift values following a stage move will be evaluated to assess time to stage stabilization in both X-, Y- positive and negative stage movement operations.

After installation of the microscope at the customer’s work location, the main microscope and accessory specifications are proven again and documented in a System Acceptance Test (SAT) report. The SAT shall include a full test completion with control protein prior to sign-off following installation, including electron diffraction data collection, processing, and test completion.

5.1.2. Pre-Validation Screening (Deliverable 2)

The vendor’s device shall pass a pre-validation screening, administered within six (6) months of contract award that will be conducted by Government, and shall meet criteria listed below:

No unmitigated Category I (CAT I), findings as described in the appropriate Defense Information System

Agency (DISA) Security Technical Implementation Guides (STIGs) located on http://iase.disa.mil/stigs/Pages/index.aspx

No unmitigated Category II (CAT II), findings as described in the appropriate Defense Information System

Agency (DISA) Security Technical Implementation Guides (STIGs) located on http://iase.disa.mil/stigs/Pages/index.aspx

No unmitigated critical or high Category I (CAT I) findings from Nessus vulnerability scans.

No unmitigated Category II (CAT II) findings from Nessus vulnerability scans.

The vendor shall mitigate all CAT I and CAT II findings discovered during the Assessment and Authorization

(A&A) process according to a schedule published by Government. Successful mitigation shall be documented by the vendor and the documentation provided to the Government.

5.1.3. Post Award Cybersecurity Requirements (Deliverable 3)

The vendor shall:

Provide a point of contact responsible for the cybersecurity of the vendor’s microscope or system throughout the lifecycle of the system.

Provide Subject Matter Experts (SMEs) to support all assessments of contracted products and materials, and meet required deliverable timelines.

Establish appropriate administrative and technical safeguards to ensure the confidentiality, integrity, and availability of Government data under their control.

Provide anticipated costs and timelines required to address any inability to meet any of the security requirements.

The vendor shall submit a report that identifies the POC, SMEs, safeguards adopted, and timelines for addressing security requirements. The report may be updated on a periodic basis as required.

5.1.4. Training (Deliverable 4)

The contractor shall provide a one-day on-site applications training in the applications and use of the equipment.

5.1.5. Maintenance and Service Support (Deliverable 5)

The contractor shall also provide a one year equipment warranty and four years of preventive maintenance and emergency-repair service contract. The contractor shall conduct Quarterly Reviews with the COR. The results of reviews will be documented and action items identified during each meeting will be tracked and reported on at the following meeting.

5.2. Management Reports and Plans

Monthly Tracking Report (Deliverable 6) The contractor shall provide a spreadsheet with detail of real time levels of effort, expenditure levels and results for activities conducted under Task 6.1.5.

Service Report (Deliverable 7) The contractor shall provide a report detailing all work and level of effort expended in support of on-site applications support, including preventive maintenance and emergency services. The report shall include a detailed list of all hours worked and workload accomplished, to include but not limited to a list of equipment serviced and materials provided.

Quality Control Plan (Deliverable 8) The contractor shall provide a Quality Control Plan (QCP) as part of the contractor’s response. The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP. At a minimum, the

QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the

Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction.

Contract Manpower Reporting Application (CMRA) (Deliverable 9) 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 WRAIR 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 2013. Contractors may direct questions to the help desk at: http://www.ecmra.mil/.

6. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the PWS within the description of the deliverable, all deliverables will be made to the COR electronically.

DELIVERABLES TABLE

PWS

Ref.

Number Title/Description Due

6.1.1 1 System Acceptance Testing Documentation Not more than 15 days following completion of successful system acceptance testing

6.1.2 2 Pre-validation Testing Documentation Within 6 months of the date of contract award

6.1.3 3 Post Award Cybersecurity Report Within 30 days of the date of contract award

6.1.4 4 Training, Warranty and Service Contract Training and written warranty and service contract within 3 days of the completion of successful completion of system acceptance testing

6.1.5 5 Quarterly Meetings and Notes Within 7 days of the first day of the first month of each quarter

6.2 6 Monthly Financial Tracking Report By the 7th day of the month following the reporting period.

6.2 7 Service Reports Not less than 24 hours following the completion of the service.

6.2 8 Quality Control Plan To be included in contractor’s proposal

6.2 9 Contractor Manpower Reporting As required by the contract

9.1.210

.1.2

10 OSHA 300A

The contractor shall complete and deliver the OSHA 300A.

1 February of each year.

6.1. Inspection and Acceptance

The COR delegated oversight of specific technical, functional and oversight responsiblities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Work Statement and all terms and conditions of this order, including all modifications.

6.2. COR Information

COR will be determined at time of award.

7. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the

Contractor’s performance in relation to performance objectives. The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the contractor. The QASP is a living document and may be updated by the Government as necessary.

The Government will use the following performance requirements to measure the performance of the contractor.

The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance

Requirements Summary Matrix” (PRS Matrix).

Performance Requirements Summary Matrix

# PWS Ref.

Performance

Objective

Acceptable

Quality Level

Performance

Measurement Method of Surveillance Incentive

1 6.1.1 Site Survey, Installation and

System Acceptance

Testing

100% 100% compliance with

System Acceptance

Testing Criteria

System Acceptance

Testing Documentation

Direct observation of system performance

Past performance

2 6.1.2 Pre-Validation

Testing

100% 100% completion of pre-validation testing and remediation of CAT I and II

Validation testing and

CAI I and II remediation documentation

Past performance

3 6.1.3 Post-Award

Cybersecurity

100% Nomination of POC, SMEs, documentation of safeguards and resolution of non-compliance issues

Acceptance of Post-

Award Cybersecurity

Report

Past performance

4 6.1.4 Training, Warranty and Service Contract

100% Completion of end-user training

Receipt of written warranty and service contract

End-user demonstration of ability to operate equipment validated by

COR direct observation

COR acceptance of warranty and service contract

Past performance

5 6.1.5 Quarterly Meetings 100% Successful scheduling Participation in meetings Past performance

8. CONTRACT MANAGEMENT

8.1. Government Management

The Contracting Officer’s Representative (COR) 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. Only the KO has the authority to enact changes to this award.

8.2. 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.

8.3. Contractor Organization

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.

8.4. Subcontract management

8.4.1. The contractor is responsible for any subcontract management necessary to integrate services performed on this contract.

8.4.2. The contractor is responsible and accountable for subcontractor performance on this contract

8.4.3. The contractor is responsible to manage task distribution to ensure there are no OCI considerations

8.4.4. Contractor my add subcontractors to their team after notification and written approval from the

KO.

8.4.5. Privy of contract is with the contractor and the subcontractor.

8.5. Foreign Nationals

A foreign national can only be hired if they have a special skill that a US Citizen cannot be found to perform. A background investigation must be completed in its entirety before unescorted access to the facility is granted. Government computer access will not be approved until a background check is done in accordance with para 18.9. Typically, a background check cannot be performed on a foreign national unless the individual has lived in the United States for three (3) of the last five (5) years.

and Notes and conduct of quarterly reviews and submittal of meeting notes

Receipt of meeting notes

6 6.2 Monthly Tracking

Report

100% Receipt of monthly tracking report

Receipt and acceptance of report

Past performance

7 6.2 Service Reports 100% Receipt of service reports

Receipt and acceptance of report

Past performance

8 6.2 Quality Control Plan 100% Included in proposal Receipt and acceptance of report

Past performance

9 6.2 Contractor

Manpower Reporting

100% Review of annual report Receipt and acceptance of report

Past performance

9. COMPLIANCE DOCUMENTS

9.1. General Compliance

9.1.1. Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), Department of the Army (DA) and Medical Research and Material Command

(USAMRMC) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

Federal regulations governing regulations for human subject’s protection are found in 45 CFR 46. The

International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at https://mrmc.amedd.army.mil/rodorphrpo.asp.

9.1.2. Occupational Safety and Health Administration (Deliverable 10)

The contractor shall comply with Occupational Safety and health Administration Standard Number

1904.32. The contractor shall deliver the 300A by February 1 of each year.

10. OTHER TERMS, CONDITIONS, AND PROVISIONS

10.1. Non-Personal Services

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.

10.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

10.3. Inherently Governmental Functions

This requirement has been reviewed and contains no services that are inherently governmental functions.

10.4. Organizational Conflict of Interest

Walter Reed Army Institute of Research (WRAIR) has categorized its requirements into two broad categories, as defined below, for purposes of identifying, avoiding or mitigating against OCIs in accordance with FAR

Subpart 9.5. These categories apply to all enterprise laboratories AFRIMS, USAMRD-A, and USAMRD-G.

These categories are defined as follows:

Global Support: Where services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the contractor in a position to influence the award decision on a contract in which they are participating. These services are identified as those having a direct impact to the operations of the greater WRAIR enterprise.

Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts within subordinate directorates/Commands.

Mitigation strategies may include: avoidance (non-participation), firewalls between existing personnel and new

Isolated Support: Services which have focused impact on a specific Branch/ Department/ Program of WRAIR rather than the WRAIR enterprise.

Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate

Mitigation Strategies: Contractor can provide a mitigation plan or acceptable self-certification that no OCI exists.

Contractor participation in more than one of these areas may give rise to an unfair competitive advantage resulting from access to advance acquisition planning, source selection sensitive or proprietary information.

Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of

Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area.

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective

Offerors that WRAIR presumes that award of a contract or order in the subject category will give rise to real or apparent OCI’s with respect to requirements in the other category and or may give rise to an OCI in the same category; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in WRAIR requirements and in identifying and, where possible, avoiding or mitigating against OCIs; and (3) to ensure that all current Contractors and prospective Offerors are afforded the maximum practicable opportunity to compete for all WRAIR requirements consistent with the restrictions required under

FAR Subpart 9.5 and sound business practices.

For purposes of identifying and/or mitigating against OCIs, WRAIR will examine all its services requirements and acquisitions regardless of the cognizant contracting activity (e.g., USAMRAA, GSA, other agency Multiple

Award Schedules, etc.) or the type of contract vehicle used (e.g., FSS order, Fair Opportunity competitive order under Multiple Award ID/IQ Contracts, competitively negotiated awards under FAR Part 15, etc.).

Each WRAIR services solicitation will therefore be designated as falling within one of the above defined categories. The applicable OCI category will be set forth in each award.

This requirement is categorized as ISOLATED SUPPORT.

Organizational and consulting conflicts of interest may arise by performing advisory or consulting support services. Organizational conflicts of interest include providing services or performing advisory or consulting work for private companies that participate or will participate in future services or contract activities

(solicitations and award). See FAR subpart 9.5.

The Contractor shall ensure that the Participation Agreement, either A and / or B as identified on each award, is signed by all staff assigned to or performing on each award before performing any work, including all subcontractors and consultants. The Participation Agreement shall be cosigned by a corporate official

(contractor Task Manager or higher). The Contractor shall also ensure that all staff understand and adhere to the terms of the non-disclosure statement, protecting the procurement sensitive information of the Government and the proprietary information of other contractors. Assignment of staff who has not executed this statement or failure to adhere to this statement shall constitute default on the part of the Contractor and the COR will immediately initiate a CDR.

10.5. Invoices

The contractor shall submit invoices monthly to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice.

The contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The contractor shall attach back up information to receiving reports for direct labor and Other Direct Costs (ODCs). Direct labor backup information shall reflect the person’s name, job title and quantity of hours worked for each pay period at a minimum. Backup information for ODCs shall list all elements of costs, such as travel breakout backup, including itinerary, dates of travel, name of employees traveling plus per diem costs shall accompany the receiving report. All ODCs exceeding $3,000 requires that the contractor conduct appropriate competition and obtain approval from the COR prior to purchase. Equipment purchases are not authorized under this contract. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

Where applicable, contractor will include additional ODC invoice details as required per protocol for any volunteer payments in support of this PWS.

10.6. Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any Sub

Contractors or specified Integrated Product/Process Team (IPT) members who have a need to know, of information developed under this order or contained in the reports to be furnished pursuant to this order without prior written approval of the COR or the Contracting Officer.

10.7. Contractor Identification

The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts. Contractors may not use or allude to former or current military rank during the performance of this work.

10.8. Attendance at Meetings

Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract or assistance agreement representatives to meet the requirements of this order. Contractor personnel shall make their contractor status known during introductions.

10.9. Anti-Terrorism and Operational Security

10.9.1. AT Level I Training.

All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, and 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 is applicable.

The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee to the COR or to the contracting officer, if a COR is not assigned, within 30 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at the following website: http://jko.jten.mil.

10.9.2. iWATCH Training.

The contractor and all associated subcontractors shall brief all employees on the local iWATCH program

(training standards provided by the requiring activity ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 15 calendar days of new employees commencing performance, with the results reported to the COR NLT 45 calendar days after contract award. (Deliverable 11) http://jko.jten.mil/

10.9.3. Army Training Certification Tracking System (ATCTS) registration for contractor employees who require access to Government information systems.

All contractor employees with access to a Government info system must be registered in the ATCTS at commencement of services and must successfully complete the DoD Information Assurance Awareness prior to access to the information system and annually thereafter.

10.9.4. For Contracts That Require an OPSEC Standing Operating program.

The contractor shall develop an OPSEC Standing Operating Procedure (SOP)/Plan within 90 calendar days of contract award, to be reviewed and approved by the responsible Government OPSEC officer. This plan will include a process to identify critical information, where it is located, who is responsible for it, how to protect it, and why it needs to be protected. The contractor shall implement OPSEC measures as ordered by the commander. In addition, the contractor shall have an identified certified Level II OPSEC coordinator per AR 530-1.

10.9.5. For Contracts That Require OPSEC Training.

Per AR 530-1, Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

10.9.6. Threat Awareness Reporting Program (TARP).

All contractor employees, regardless of whether or not they possess a security clearance, must complete

TARP training on an annual basis per USAMRMC command directive, as outlined in USAMRMC

Memorandum for Record, Command Guidance for TARP Training Compliance, dated 06 January 2016.

The training can be conducted face-to-face in a classroom setting or on-line. The supported military organization will coordinate all face-to-face training. Personnel may access the on-line training via the

ALMS website under the course name, U.S. Army Threat Awareness and Reporting Program (TARP)

Course. This training shall be completed within 60 calendar days after the contract award or after new employees commence performance, and annually thereafter (Deliverable 12).

10.10. Sexual Harassment / Assault Response and Prevention (SHARP)

The contractor shall comply with OTSG/MEDCOM Policy Memo 16-033, Policy for Reporting Incidents of

Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP).

The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

The contractor shall require all contractor personnel with knowledge of an incident of sexual assault or sexual harassment occurring on a Government facility (Deliverable 13), to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the Government's COR or Contracting Officer.

All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

The contractor shall ensure all service providers receive Sexual Harassment/Assault Response and Prevention

(SHARP) training (Deliverable 14) not later than 60 calendar days after contractor personnel begin performance under this contract and annually thereafter. Training can be self-study using the attached slides, obtained online for contractor personnel with an Army Knowledge On-line (AKO) account or in person. In-person training through USAMRAA can be scheduled by contacting 301-619-8937 for class date/time and availability. If the employee has an AKO account, they can access training online at Army AKO https://www.us.army.mil/. Once in AKO:

Under the "Self Service" tab, click on "My Training"; once that page comes up, in the center of the page, click on the ALMS logo or the "Access the ALMS" option. On the left hand side of the page that launches, click on

“Search”, and enter “SHARP Standing Strong” in the Search option (in about the middle of the page that opens). Sexual Harassment/Assault Response and Prevention Standing Strong Training (Version: FY15) will appear as one of your options. Under that option, click on the “Begin Registration” option.

10.11. Information Security Program Training

The Information Security Program (ISP) Training Certification meets an Army mandatory annual training requirement for this subject. This Certification is the consolidation of the training topics previously provided in the Security Training - Initial Security Orientation and Security Training - Annual Security Refresher Training courses. The contractor shall ensure all service providers receive ISP training not later than 30 calendar days after contractor personnel begin performance under this contract and annually thereafter (Deliverable 12).

Training can be found at - https://www.lms.army.mil/ (Deliverable 15)

10.12. Compliance with Relevant DoD, Service, and Institutional Policy Regulations.

The Contractor shall comply with HIPAA and all relevant DoD/USG regulations for collection, storage, and transfer of sensitive data and PHI. In addition, the Contractor will comply with all requirements for communication of findings and publication in the scientific peer reviewed literature (e.g. Public Affairs clearance and Operational Security clearance for dissemination). Finally, all contractor employees must complete a yearly HIPAA training that is on Joint Knowledge Online (JKO). (Deliverable 16)

10.13. Personally Identifiable Information (PII) and Protected Health Information (PHI)

The contractor shall comply with the DHA Procedures, and Information (PGI) 224 – Protection of Privacy and

Freedom of Information, revised 17 May 2015. The contractor may access PII in the course of task response to the requirements of this contract, as such the contractor shall comply with the document entitled “Personally

Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Requirements”.

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 DFAR Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoD 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 (MHS) 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.

IT services that collect, maintain, use, or disseminate personally identifiable information must be managed in a manner that protects privacy, in accordance with section 552a of Title 5, U.S.C. (Reference (aa)), DoD 5400.11

(Reference (ab)) and DoD 5400.11-R (Reference (ac)). DoDI 5400.16 (Reference (ad)) established the guidance for development, review, and approval of Privacy Impact Assessments, in accordance with chapter 36 of Title

44, U.S.C. (Reference (ae)).

10.14. Public Key Infrastructure Authentication and Encryption

Contractors shall follow the DoD standards, policies, and procedures related to the use of Public Key

Infrastructure (PKI) certificates and biometrics for positive authentication including authentication to DoD private web servers or applications. Where interoperable PKI is required for the exchange of unclassified information, including the encryption of e-mail containing sensitive information, between DoD and its

Contractors, industry partners shall obtain all necessary certificates if they are not eligible for a DoD Common

Access Card. (refer to: http://iase.disa.mil/pki/eca/ and http://www.cac.mil/)

10.15. Network Security

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, the contractor must present a copy of this investigation to the WRAIR 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 WRAIR Personnel Security https://www.lms.army.mil/

Manager at the time of in-processing for all contractor personnel assigned to the contract.

Contractor personnel shall use only Government-provided computer equipment; and shall follow all applicable statutes, regulations and policies governing DoD, MEDCOM, USAMRMC, and WRAIR 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:

10.15.1. 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 WRAIR regulatory repository for review):

a. The National Security Act of 1947

b. Title 40/Clinger-Cohen Act

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

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

e. Subchapter III of chapter 35 of Title 44, United States Code (also known as the “Federal

Information Security Management Act (FISMA) of 2002”)

f. National Security Telecommunications and Information Systems Security Policy No. 11, "Revised Fact Sheet National Information Assurance Acquisition Policy" and associated

"Frequently Asked Questions"

g. National Institute of Standards and Technology (NIST) Special Publication (SP) 800-39

h. Federal Information Processing Standards

i. DoD Instruction 8500.01, “Cybersecurity,” March 13, 2014

j. DoD Instruction 8500.2, "Information Assurance Implementation"

k. DoD Instruction 8580.1, "Information Assurance in the Defense Acquisition System"

l. DoD Instruction 5000.02, “Operation of the Defense Acquisition System,”

m. DoD Directive 8570.01, "Information Assurance Training, Certification, and Workforce

Management"

n. Chairman of the Joint Chief of Staff Instruction 6510.01E, "Information Assurance (IA) and

Computer Network Defense (CND)"

o. Defense Acquisition Guidebook – Chapter 7 Acquiring Information Technology and

National Security Systems, Section 7.5 Information Assurance

p. DoD Instruction 8510.01, "Risk Management Framework (RMF) for DoD Information

Technologies"

10.15.2. Each proposal under this contract, will be screened for compliance with applicable Cybersecurity statutes, policies, and procedures. Specific requirements will be stated in the performance work statement/statement of objectives. This special contract provision shall be updated by reference for any changes to source documents. Any new laws or policies applicable to Cybersecurity subsequent to issuance of this contract will be incorporated into the basic contract unilaterally without equitable adjustment to the basic contract. Any equitable adjustment shall be assessed by individual contracts that may be affected by the change as applicable.

10.15.3. Non-US citizens are not being adjudicated for WRAIR trustworthiness determinations at this time. Non-US Citizens are not allowed access to DoD IT systems unless approved by an authority designated in Appendix 6, DoD 5200.2-R. Only US citizens shall be granted access and assigned to sensitive duties. Exceptions to these requirements shall be permitted only for compelling national security reasons (DoD 5200.2-R. C2.1.1, AP6.6.1)

10.16. Workplace Safety

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

The Contractor will be required to ensure compliance with Occupational Health physicals or vaccinations in support of the PWS. These shall be documented and charged as an ODC.

The contractor shall maintain an OSHA 300a log for all reportable (greater than first aid, lost time, lost days, transfer). The contractor shall provide a quarterly report of all mishaps, regardless of class or reportability.

Annually, the contractor shall provide a 300A (summary) report to the COR and KO.

10.17 Cybersecurity Regulations and Guidance

The vendor shall use and comply with the most recent published versions of the following references as well as all regulations or guidance referenced within those publications:

a. United States Law

i. The Health Insurance Portability and Accountability Act of 1996 (HIPAA)

ii. The Federal Information Security Management Act (FISMA)

iii. The E-Government Act of 2002

b. Office of Management and Budget (OMB)

i. The following publications are located at https://www.whitehouse.gov/omb/agency/default

ii. Circular A-130

iii. Guidance M-05-24, Implementation of Homeland Security Presidential Directive (HSPD)

12-Policy for a Common Identification Standard for Federal Employees and Vendors

c. National Institute of Standards and Technology (NIST)

i. The following publications are located at http://www.nist.gov/publication-portal.cfm

ii. NIST Special Publication (SP) 800-37 – Guide for Applying the Risk Management

Framework (RMF) to Federal Information Systems

iii. NIST SP 800-53 – Security and Privacy Controls for Federal Information Systems and

Organizations

d. Federal Information Processing Standards (FIPS)

i. The following publications are located at http://www.nist.gov/itl/fipscurrent.cfm

ii. FIPS Publication (FIPS PUB) 140-2, Security Requirements for Cryptographic Modules

iii. FIPS PUB 199 – Standards for Security Categorization of Federal Information and

Information Systems

iv. FIPS PUB 201-2, Personal Identity Verification of Federal Employees and Vendors

e. Department of Defense (DoD)

i. The following publications are located at http://www.dtic.mil/whs/directives/

ii. DoD Instruction 5200.2, DoD Personnel Security Program (PSP)

iii. DoD Instruction 8500.1, Cybersecurity

iv. DoD Instruction 8520.02, Public Key Infrastructure (PKI) and Public Key (PK) Enabling

v. DoD Instruction 8510.01, Risk Management Framework Process (RMF)

vi. DoD Instruction 8551.1, Ports, Protocols, and Services Management (PPSM)

vii. DoD Instruction 8580.02, Security of Individually Identifiable Health Information in

DoD Health Care Programs

viii. DoD Instruction 6025.18, Privacy of Individually Identifiable Health Information in DoD

Health Care Programs

ix. DoD Directive 5400.11, DoD Privacy Program

x. DoD Manual 5400.11-R, Department of Defense Privacy Program

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government

0002 Destination Government Destination Government

0003 Destination Government Destination Government

1001 Destination Government Destination Government

2001 Destination Government Destination Government

3001 Destination Government Destination Government

4001 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 N/A WRAIR

RECEIVING

503 ROBERT GRANT AVENUE

SILVER SPRING, MD DC 20910-7500

W74MYF

0002 N/A (SAME AS PREVIOUS LOCATION)

0003 POP 17-AUG-2020 TO

16-AUG-2021