Performance-Work-Statement.docx

Performance Work Statement USAARL Post Mortem Human Subject (PMHS) Services

SECTION 1 PURPOSE

1.1. Introduction

The United States Army Aeromedical Research Laboratory (USAARL) is a subordinate Command of the United States Army Medical Research and Materiel Command (USAMRMC). USAARL is one of USAMRMC’s six research laboratories in the continental United States, responsible for planning and executing basic and applied medical research. USAARL is located at Fort Rucker, Alabama, the home of Army Aviation and the U.S. Army Aviation Center of Excellence (USAACE).

1.1. Mission

The Commander, USAARL, directs the management of a number of medical research, development, and acquisition programs related to aeromedical and ground ambulance evacuation and the prevention of injury. USAARL’s military applied research primarily supports USAMRMC’s Military Operational Medicine Research Program (MOMRP) and the Joint Program Committee 5 (JPC-5) research objectives. The mission of the USAARL is to preserve and enhance the health, safety, combat effectiveness, and survivability of the U.S. Army aviator and Soldier. USAARL is the U.S. Army’s lead lab for research in combat injury prevention, head injury prevention, visual performance and protection, acoustic performance and protection, and operator performance under stress.

USAARL's research includes developing injury prevention and health performance standards, determining the effectiveness of life support equipment and personnel protective equipment, and preventing and mitigating ground and aircrew biomechanical injuries. The USAARL’s facilities and scientific experience and expertise specialize in human protection through development, test, and evaluation of helmets, restraints, and medical equipment.

USAARL has maintained a reputation as an honest broker of Soldier safety, and by combining basic science, technology, medicine, and engineering, USAARL continues to enhance the safety and performance of mounted and dismounted Service Members.

1.2. Background

The U.S. Army Medical Research Acquisition Activity (USAMRAA) on behalf of its customer activity, the U.S. Army Aeromedical Research Laboratory (USAARL) located at Fort Rucker, Alabama has a recurring requirement for Post Mortem Human Subjects (PMHS) Services. The Injury Biomechanics and Protection Group’s (IBPG) mission is to develop biomedical assessment tools and performance standards for the prevention and mitigation of Soldier injuries. The primary threat-based competency is Blunt, Blast, and Accelerative Injury and Protection with a focus to the head and spine and overall whole body response. In order to measure human tolerance to measure human injury response to develop biofidelity curves and injury criteria, post mortem human subjects (PMHS) whole body and components are required.

1.3. Scope

Each year, the contractor shall provide the services necessary to assure the availability of whole body, cervical spines, lumbar spines, cephalus-C7, whole arms, and/or mid-femur to toe-tip specimens are available for military research into human tolerance to blunt impact accelerations. Services include donor consent and retrieval, screening (serology, medical imaging), shipping, disposal, and, at the discretion of the Government, storage and additional medical imaging of PMHS. All PMHS specimens will be from fresh frozen, un-embalmed donors. PMHS specimens shall meet Army-specific regulatory requirements described in the “Army Policy for Use of Human Cadavers for Research, Development, Test and Evaluation, Education, or Training,” dated 20APR2012, as well as study-specific inclusion-exclusion criteria. The contractor shall be familiar with and comply with all federal and state laws applicable to the services listed above.

This contract will be used to procure U.S. Army Medical Research and Material Command (USAMRMC) OCI Category for Services that falls within the scope of the PWS. The contractor shall provide an OCI certification with their proposal. If there is an OCI, the contractor shall provide a draft OCI Mitigation Plan with their proposal.

1.6. Non-Disclosure Statement (NDS) (Deliverable 2, Exhibit 2).

The contractor shall ensure that all contractor personnel are advised of nondisclosure policies as well as restrictions from communicating official business to media outlets. The contractor personnel may be required to sign specific non-disclosure statements as required by the contract. The contractor shall provide signed non-disclosure statements from each personnel assigned, prior to performing any services.

SECTION 2 GENERAL REQUIREMENT

2.1. Performance

2.1.1. Place of Performance

2.1.1.1. Contractor owned and/or leased off-post facilities. All initial tissue harvesting, screening (serology, medical imaging), shipping, and disposal will be conducted by the contractor at one of the contractor’s facilities. Upon request of the Government, storage of PMHS will also be at one of the contractor’s facilities.

2.1.1.2. Primary on-site Government location. The PMHS work to be conducted is located on the USAARL campus 6901 and 8825 Farrel Road, Fort Rucker, AL 36362. Deliveries will be made to each of these buildings depending on component.

2.1.2. Period of Performance. This contract is for one (1) twelve (12) month Base Period and four (4) twelve (12) month Option Periods. The periods of performance for this contract are as follows:

2.2. 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.

2.3 Contract Management

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

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

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

2.3.2.3. The contractor shall develop and provide a Contract Management Plan (CMP) (Deliverable 3) with their proposal. The CMP shall include a key points of contact for program management and customer service.

2.3.2.4. The contractor shall provide a Quality Control Plan (QCP) (Deliverable 4) that is based on industry best practices for the services being provided under this contract. The contractor shall 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.

2.3.3. Subcontract Management. The subcontractor shall be:

2.3.3.1. Responsible for any subcontract management necessary to integrate services performed on this contract.

2.3.3.2. Responsible and accountable for subcontractor performance on this contract.

2.3.3.3. Responsible to manage task distribution to ensure there are no OCI considerations.

2.3.3.4. Contractors may add subcontractors to their team after notification and approval from the PCO and COR. Cross teaming shall be permitted.

2.4. Reports

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

2.4.2. Monthly Financial Tracking Report (Deliverable 5). The contractor shall provide a spreadsheet with detail of real time expenditure levels of every contract line item number (CLIN) and delivery order. The initial report is due 45 days after contract award and monthly thereafter.

2.4.3. PMHS Service Status Report (Deliverable 6). The contractor shall provide a monthly report detailing all work, including subcontractor’s work, and where there is critical or significant data related to the provided support. The report shall include at least, the minimum turn-around time required to certify and calibrate each piece of equipment listed, detailed list of work-in-progress, and work accomplished, to include but not limited to, last service date and projected due dates.

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

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the Army 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/.

2.5. Training Requirements

2.5.1. Completion of Training Requirements (Deliverable 8). The contractor shall track and complete refresher training to maintain training compliance and readiness status. The contractor shall submit certificates of completion for each affected contractor and subcontractor personnel to the COR within 5 calendar days after completion of training by all personnel and subcontractor personnel. Contractor shall track and complete refresher training to maintain training compliance and readiness status as required.

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

2.5.1.2. iWATCH Training. The contractor and all associated subcontractors shall brief all employees on Fort Detrick iWATCH program, available on-line at http://www.detrick.army.mil/ready/iwatch.cfm. This locally developed on-line training will be used to inform contractor personnel of the types of behavior to watch for and instruct them how to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 30 calendar days of new contractor personnel commencing performance, with the results reported to the COR no later than 30 days after contract award.

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

2.5.1.4. Threat Awareness and Response Program (TARP). Training applies to those contract personnel who have a security clearance. Applicable contractor shall complete this required non-residential training every 365 days, available on-line at https://www.lms.army.mil. It takes approximately two hours to complete.

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

2.5.1.6. Combat Trafficking in Persons General Awareness Course (CTIP). Training applies to those contractor personnel who perform contract requirements Outside Continental United States (OCONUS). Applicable contractor shall complete this required non-residential training every 365 days, available on-line at https://www.lms.army.mil (AKO, then select ALMS). It takes approximately 30 minutes to complete.

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

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

2.5.1.9. Sexual Harassment/Assault Reponses and Prevention (SHARP) Contractor Training. This training is IAW USAMRAA Policy 17-01, Sexual Harassment/Assault Reponses and Prevention (SHARP) Contractor Guidance.

2.5.1.10. 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 Responses Program (SHARP). The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

2.5.1.11. The contractor shall require all contractor personnel with knowledge to an incident of sexual assault or sexual harassment occurring on a Government facility, 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.

2.5.1.12. Government Unique Training. The contractor shall ensure all services providers receive SHARP Training no later than 60 calendar days after contractor personnel begin performance under this contract and annually thereafter. Training can be self-study using the provided 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/. (Deliverable 8)

2.6. Government Work Days and Hours

2.6.1. In the event of on-equipment contractor work at Government facilities:

2.6.1.1. Contractor personnel shall perform services during regular duty hours. Duty hours range from 0600 to 1800 hours, Monday through Friday. The 8 hour regular duty day will be determined by the COR.

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

2.6.1.3. 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:

2.6.1.3.1. New Year’s Day, 1 January

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

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

2.6.1.3.4. Memorial Day, last Monday in May

2.6.1.3.5. Independence Day, 4 July

2.6.1.3.6. Labor Day, 1st Monday in September

2.6.1.3.7. Columbus Day, 2nd Monday in October

2.6.1.3.8. Veteran’s Day, 11 November

2.6.1.3.9. Thanksgiving Day, 4th Thursday in November

2.6.1.3.10. Christmas Day, 25 December

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

2.7. Travel (Reserved)

2.7.1. Travel Process.

2.7.1.1. Travel Request Procedures.

2.7.1.2. Travel Approval Process.

2.7.1.3. Travel Claim Procedures.

SECTION 3 PERFORMANCE REQUIREMENTS

3.1 PMHS Services

The contractor shall provide all necessary resources required to acquire, screen, ship, and, at the discretion of the Government, store, receive, and/or dispose of fresh frozen post mortem human subject (PMHS) specimens. Services include donor consent and preparation of donor, screening (serology and initial medical imaging), shipping to and from USAARL, and, at the discretion of the Government, short term storage or additional medical imaging (CT, DEXA). All PMHS specimens will be from fresh frozen, un-embalmed donors. PMHS specimens shall meet Army-specific regulatory requirements described in the “Army Policy for Use of Human Cadavers for Research, Development, Test and Evaluation, Education, or Training,” dated 20APR2012, as well as study-specific inclusion-exclusion criteria. The contractor shall be familiar with and comply with all federal and state laws applicable to the services listed above. This section specifies the Performance Objectives and Performance Elements for the contract.

3.1.1 Objective 1 – DONOR CONSENT AND PREPARATION. The contractor shall consent potential donors and handle retrieval and preparation of potential donors to assure un-embalmed, fresh frozen PMHS specimens are available for military research into human tolerance. The PMHS specimens or components required are listed in Table 1.

Whole body minus hand or foot

Head to T1

Cervical Spines (C1 – T1)

Lumbar Spines (L1 – sacrum)

Whole arm (head of humerus to finger-tip)

Mid-femur to toe-tip

3.1.1.1 The contractor will screen potential PMHS specimens to ensure specimens meet inclusion criteria specific to the research study. The basic inclusion criteria will be as follows:

3.1.1.2. Occasionally, the Government may have additional inclusion criteria specific to research questions. Additional inclusion criteria will be further specified in the orders the Government submits to the Contractor. Examples of additional inclusion criteria:

3.1.2. Objective 2 – ORDERING, SCREENING, AND PRE-ACCEPTANCE. PMHS services are expected to be flexible on an as needed basis, not a fixed schedule. Periods of foreseen services could be as often as every month or as sporadically as once a year. However, when the Government requires PMHS services, the Government will complete the contractor forms necessary with PMHS type and respective quantities to provide the Contractor. The Contractor shall review all donor summaries and provide offers to the Government that fulfill the requirements below.

3.1.2.1. The Contractor shall notify the COR when a potential PMHS specimen becomes available to allow the Government the opportunity to accept or decline use of the potential PMHS specimen. At the time of notification, the contractor shall provide a donor summary (Deliverable 9) with the following information:

3.1.2.2. The COR, or appointed Government representative, will review the above documentation and determine if the potential donor meets the minimum criteria. The Government will inform the Contractor if the potential donor meets the minimum criteria, and the Contractor will provide x-rays (Deliverable 10) of the research anatomical area of interest, Anterior-Posterior and Lateral, at a minimum. The Government will communicate the research anatomical area of interest.

3.1.2.3. The COR, or appointed Government representative, will review the x-rays to confirm the donor is free of traumatic injury and fractures. The COR will inform the Contractor of pre-approval of the donor to be shipped or rejection of the donor.

3.1.2.4. The Contractor shall provide redacted copies of the donor consent forms (Deliverable 11) for each PMHS specimen pre-approved by the Government. The redacted copies shall not include any Personal Identifiable Information (PII). The redacted copies shall include the PMHS specimen’s unique identification number generated by the Contractor.

3.1.3. Objective 3 – SHIPPING AND FINAL ACCEPTANCE. The Contractor shall ship PMHS specimens within a Government-specified time period after Government acceptance of the potential specimen and indication that the requesting agency is ready to receive the specimen. Typical quantities per delivery (Deliverable 12) is in Table 2 below; however, different quantities may be requested pending research requirements and USAARL storage availability. The contractor shall coordinate deliveries with the COR or their designee to ensure personnel will be available to take receipt of the delivery. The contractor shall ensure each specimen is clearly identified with the specimen unique identification number generated by the contractor. PMHS specimens shall be packaged to prevent damage during transit. PMHS specimens shall not arrive at the requesting agency’s location in a completely thawed state and shall be packaged to prevent leakage from thawing that may occur during transit. The contractor shall ship PMHS specimens in accordance with all applicable federal and state regulations as described in Title 49 of the Code of Federal Regulations (49 CFR) and the Defense Transportation Regulation (DTR) 4500.9-R.

Table 2. Estimated Delivery Quantities (per delivery)

3.1.3.1 FAR 13.303-3(a) (5) requires that all shipments made under this agreement be accompanied by delivery tickets or sales slips that contain the following minimum information:

3.1.3.2. The deliverable services ordered under this contract are deliverable to Bldg 6901 Farrel Road or Bldg 8825 Andrews Avenue, Fort Rucker, Alabama. All orders will be coordinated with the COR.

3.1.3.3. The Contractor shall ship the PMHS once an acceptable number of specimens are pre-approved. Upon arrival of the PMHS specimen and associated documentation to USAARL, the COR or their representative will exercise the QASP. CT imaging will be conducted by USAARL to determine if the PMHS is free of traumatic injury as specified in the PWS. If the specimen is IAW with the QASP and PWS, the COR will provide the Contractor with final acceptance of the specimen. If the specimen deviates from the QASP or PWS, the COR will reject the specimen and return the specimen to the Contractor.

3.1.3.4. The Contractor shall provide return shipping labels and materials to the Government to return all specimens for final disposition once research activities are complete (Deliverable 12). The COR will coordinate shipments with the Contractor. The COR will ensure each specimen is labeled appropriately with the number furnished by the Contractor. PMHS specimens shall be packaged to prevent damage during transit. PMHS specimens shall be shipped in accordance with all applicable federal and state regulations as described in Title 49 of the Code of Federal Regulations (49 CFR) and the Defense Transportation Regulation (DTR) 4500.9-R.

3.1.4. Objective 4 – FINAL DISPOSITION. The Contractor shall provide final disposition services for the PMHS specimens, including return shipment services to the Contractor’s facility. The Contractor shall dispose of the PMHS tissue in accordance with the donor or next-of-kin’s wishes, if known. If the donor or next-of-kin provide no guidance as to disposition of the PMHS tissue, the contractor shall dispose of the PMHS tissue in accordance with the contractor’s standard procedures. The contractor’s standard procedures for disposition of PMHS tissue shall be conducted in accordance with applicable local, state, and federal regulations.

3.1.5. Objective 5 – OPTIONAL TEMPORARY STORAGE. At the request of the Government, the Contractor shall temporarily store Government pre-approved PMHS specimens. Execution of this task will be exercised in the event the requesting agency does not have sufficient storage capacity to take immediate delivery of the specimens. The Contractor shall have the capability of temporarily storing Government pre-approved PMHS specimens at temperatures of -20° Celsius (-4° Fahrenheit) or below.

3.1.6. Objective 6 – OPTIONAL MEDICAL IMAGING. At the request of the Government, the contractor shall provide additional medical imaging services for Government-accepted PMHS specimens (Deliverable 13). Medical imaging modalities that may be requested include radiographic imaging (x-ray), computed tomography, medical resonance imaging, and dual-energy x-ray absorptiometry (DEXA) scanning. Meta-data associated with medical imaging files shall not include any PII; the meta-data shall include the PMHS specimen’s unique supplier-generated identification number. Medical imaging shall be provided to the Government in Digital Imaging and Communications in Medicine (DICOM) format on compact disc or digital versatile disc.

3.1.7. Objective 7 – INVOICING. The COR will process invoices for payment only when products and services are received, inspected, and accepted at the delivery location. Each invoice shall identify the appropriate CLIN number to be billed. If CLINs are not properly identified on an invoice, the invoice will be rejected. Additional requirements for invoicing:

3.2. Performance Requirement Summary Matrix

b) STD: Contractor supplies x-rays, at the request of the COR.

b) STD: Contractor supplies return shipping labels and materials.

Periodic Surveillance

3.3. Quality Assurance Surveillance Plan. Every DoD contract awarded for services in excess of $2,500.00 shall contain a Quality Assurance Surveillance Plan (QASP) as discussed in the FAR 46, Government Contract Quality Assurance. A QASP is a plan that specify the particular services the COR will inspect and the method(s) used to complete that surveillance. Each offeror shall digest the PWS in this RFP and offer a QASP associated therewith. The QASP shall be submitted as part of the offeror’s technical proposal. It will not be subjectively evaluated and rated. However, it may be discussed during the pre-award period for finalization prior to its inclusion in the awarded contract.

SECTION 4 SPECIAL REQUIREMENT

4.1. Government Furnished Property (Not Applicable)

4.2. Contractor Furnished Property (Not Applicable)

4.3. Security and Safety

4.3.1. Access and General Protection/Security Policy and Procedures. The contractor and all associated subcontractors’ personnel 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 also provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office. The contractor workforce shall comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DoD, HQDA, and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

4.3.2. Contractors Requiring Common Access Card (CAC). (Not Applicable)

4.3.3. Contractors That Do Not Require CAC, But Require Access to a DoD Facility or Installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, IAW status of forces agreements and other theater regulations.

4.3.4. Contractor Personnel Who Require Access to Government Information Systems. (Not Applicable)

4.3.5. Prior to commencement of on-site services, the contractor shall provide the COR, within seven (7) calendar days in advance of the event, full names, date of birth, place of birth and Social Security numbers (or equivalent identification numbers for non-U.S. citizens) of all personnel who will be entering Army-controlled installation and facilities.

4.3.6. The contractor shall ensure that its personnel entering Army-controlled installations or facilities have obtained access badges and passes IAW facility regulations and that these badges and passes are obtained in advance so as not to delay the accomplishment of contracted services.

4.3.7. 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 personnel no longer requires access to the installation and facility. USAARL specific access badges shall be returned upon completion of on-site work and prior to departure.

4.3.8. Force Protection Condition (FPCON) impact on work levels. The contractor workforce shall comply with all personal identity verification requirements as directed by DoD, Headquarters Department of the Army (HQDA), and local policy. In addition to the changes otherwise authorized by the changes clauses of this contract, should the FPCON at any individual facility or installation change, the Government may require changes in contractor security matters or process. IAW Department of Defense Instructions (DoDI) 2000.16, DoD AT Standards, the FPCON is defined as follows:

4.3.8.3. 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.

4.3.8.4. 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. See also anti-terrorism

4.3.8.5. During FPCONs Charlie and Delta, non-essential services are discontinued. Designated essential service will resume when the FPCON level is reduced to level Bravo or lower.

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

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

4. 4. Security Requirements. The contractor shall not possess or store classified information at the contractor’s facility; therefore, level of safeguarding required is not applicable to this contract.

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

4.4.2. DD Form 254, DoD Contract Security Classification Specification is not required for this contract.

4.5. Proprietary Information Assurance and Security. The contractor shall comply with Office of Management and Budget (OMB) Circular A-130, “Management of Federal Information Resources,” which requires Certification and Accreditation (C&A) of all federal information systems every three (3) years at a minimum or as changes that require re-accreditation occur. This C&A requirement ensures the effective safeguarding of sensitive but unclassified (SBU) data against unauthorized modification, disclosure, destruction, and denial of service, as directed by the DoD.

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

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

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

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

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

4.7. Other Direct Costs

4.7.1. ODCs shall be billed on a cost reimbursable basis. Costs are defined as the purchase price of materials or service plus General and Administrative charges (G&A) or material and handling charges (M&H) in accordance with FAR 31.205-26, Material Cost. ODC also includes travel in accordance with FAR 31.205-46, Travel.

4.7.2. All ODCs shall be reported as stated in the Monthly Progress Report as required.

SECTION 5 DELIVERABLES

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

Coordinated once a full delivery of pre-approved PMHS is achieved and scheduled in at least 2 weeks prior to delivery onsite.

b) Physical materials with delivery of PMHS

SECTION 6 APPLICABLE DIRECTIVES, REGULATIONS, AND POLICIES

6.1. Environmental Requirements

6.1.1. Mandatory Compliance. Occupational Safety and Health Act and AR 200-1 Environmental Protection and Enhancement.

6.1.2. Non Mandatory Documents. Additional DoD and Army environmental program and regulations are available on-line at http://aec.army.mil.

6.2. Applicable Directives. (Reserved)

6.3. Mandatory Compliance (Reserved)

“Army Policy for Use of Human Cadavers for Research, Development, Test and Evaluation, Education, or Training,” dated 20APR2012.

SECTION 7 DEFINITIONS AND ACRONYMS

7.1. Definitions

7.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

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

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

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

7.1.7. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

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

7.1.9. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

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

7.1.11. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

7.1.12. WORK DAY. The number of hours per day the contractor provides services IAW the contract.

7.1.13. WORK WEEK. Monday through Friday, unless specified otherwise.

7.2. Acronyms

The acronyms listed below will assist in recognizing certain key words, phrases, or departments as defined in the contract, as well as any forthcoming dialogue with the contractor.

7.3. Related Documents (Reserved)