HT942525R0048_Final_05.13.2025.docx

HT942525R0048

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 HT942525R0048. The solicitation is issued as a Request for Proposal (RFP). Provisions and clauses in effect through Federal Acquisition Circular 2024-06 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 associated North American Industrial Classification System (NAICS) code for this procurement is 541990.

The U.S. Army Aeromedical Research Laboratory (USAARL) has a requirement for an IDIQ contract that provides Post Mortem Human Subjects (PMHS) Services for USAARL, for a five (5) year ordering period. The estimated ordering periods are outlined below:

Ordering Period: 01 July 2025 – 30 June 2030

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

ORDERING INFORMATION

1. ORDERING INFORMATION:

1.1. The Contractor shall furnish equipment, if and when requested by the Contracting Officer (CO), an authorized Government Purchase Card (GPC) Ordering Officer or authorized representative during the ordering period specified in paragraph 1.5. below. Orders made hereunder may be written, via a Delivery Order issued on a SF1449 by the CO, or oral, via notification from an authorized GPC Ordering Officer.

1.1.1. Equipment purchased under the IDIQ shall be limited to the items specified in the Statement of Requirement and the MECs.

1.2. The following offices are hereby authorized to place orders under the IDIQ:

US Army Medical Research Acquisition Activity (USAMRAA)

808 Schreider Street Fort Detrick, Maryland 21702

US Army Aeromedical Research Laboratory (USAARL) 6901 Farrel Road Fort Rucker, AL 36362-0577

1.3. For orders falling below $25,000.00, USAARL Government Purchase Card (GPC) Ordering Officers will be placing phone/email orders directly with the contractor for one-time deliveries. GPC Ordering Officers will provide a GPC Order Number, for tracking and identification purposes, and a credit card number at the time the orders are placed. The GPC Order Number shall consist of the IDIQ Number followed by the Fiscal Year the order is placed and GPC Order Number. For example: HT942525DXXXX-25-0001.

The GPC Ordering Officer(s) authorized to place orders directly with the contractor are listed below:

To be completed at time of award

1.4. For orders exceeding $25,000.00, a USAMRAA Contracting Officer (CO) will order equipment against the IDIQ contract through issuance of written delivery orders, via a SF 1449, signed by the CO. Delivery Order will be executed in writing by the CO and transmitted electronically via e-mail.

1.4.1. Written delivery orders shall contain the following “minimum” information:

- Date of Order

- IDIQ Number and order number

- Item Number, description, quantity, and unit price

- Delivery Date and place of delivery

- Accounting and appropriation data

- Payment Office address

- Invoicing Instructions

1.4.2. Except as specified in paragraphs 1.2. and 1.3. above, no order, statement, or conduct of Government personnel who visit the contractor's facility or in any other manner communicate with contractor personnel during the performance of this contract shall constitute a change under the "Changes" clause of this contract.

1.4.3. The contractor shall not comply with any order, direction or request of Government personnel unless it is issued in writing and signed by the CO; is ordered by an authorized GPC Ordering Officer referenced in paragraph 1.2. above, or, pursuant to specific authority otherwise included as a part of this contract.

1.4.4. The CO is the only person authorized to approve changes in any of the requirements of this contract and, notwithstanding provisions contained elsewhere in this contract, the said authority remains solely the CO's. In the event the contractor effects any change at the direction of any person other than the CO, the change will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in charges incurred as a result thereof.

1.5. The IDIQ contract shall consist of one, 60-month ordering period. The estimated ordering period is 01 July 2025 through 30 June 2030.

1.6. The contractor shall identify all correspondence, reports, drawings, and other pertinent papers in connection with the IDIQ by imprinting thereon the Delivery Order and IDIQ number, plus any other references furnished by the CO.

1.7. The ordering period for the IDIQ shall consist of a five (5) year ordering period. The Contracting Officer shall review, at least annually, the base contract to determine if the contract remains effective in meeting the Government’s need, represents the best value to the Government, and to determine if price adjustments are needed. Note that if any products under the contract change over the next five (5) years, please contact the USAMRAA Contract Specialist and Contracting Officer to request a modification to incorporate the updated products and pricing.

PROHIBITION OF USE OF HUMAN

PROHIBITION OF USE OF HUMAN CADAVERS

PROHIBITION - READ FURTHER FOR DETAILS

Research, development, testing and evaluation (RDT&E), education or training activities involving human cadaveric specimens (with the exception of activities solely using established/existing human cadaveric cell lines under this contract shall not begin until approval is granted in accordance with the Army Policy for Use of Human Cadavers for RDT&E, Education, or Training, 5 November 2019 and the USAMRDC Policy #78 “Use of Human Cadavers for RDT&E Education and Training” dated 3DEC2024, as well as study-specific inclusion-exclusion criteria.

(https://mrdc.health.mil/index.cfm/collaborate/research_protections).

The USAMRDC Office of Human and Animal Research Oversight (OHARO) is the Action Office (usarmy.detrick.medcom-usamrmc.other.hrpo@health.mil ) for this policy. Approval must be obtained from the USAMRDC OHARO. Contractors must coordinate with the Contracting Officer Representative (COR) to ensure that proper approvals are obtained. ORP will issue written approvals to begin under separate notification to the contractor. Written approval to proceed from the USAMRDC OHARO is also required for any subcontractor that will use funds from this award to conduct RDT&E, education or training involving human cadaveric specimens.

Contractors must promptly report problems related to the conduct of the activity involving cadavers or the procurement, inventory, use, storage, transfer, transportation, and disposition of cadavers to the USAMRDC OHARO. Contractors must maintain complete records of the activity.

The USAMRDC or designees must be permitted to observe the activity upon request and/or audit activity records to ensure compliance with the approved protocol or applicable regulatory requirements.

Non-compliance with these terms and conditions may result in withholding of payments and/or the termination of the contract.

(End of Requirement)

Service - Whole or partial Cadaver

FFP

Whole body minus hand or foot Head to T2 Cervical Spines (C1 – T1) Lumbar Spines (L1 – sacrum) Whole arm (head of humerus to finger-tip) Mid-femur to toe-tip Inclusive of shipping, final acceptance, and cremation all in accordance with Government's Performance Work Statement (PWS) 5- year ordering period - 06/15/2025 - 06/14/2030 FOB: Destination

PSC CD: AC34

MAX

NET AMT

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

DELIVERY INFORMATION

14-JUN-2030

U S ARMY AEROMEDICAL RESEARCH LABOR

FARRELL RD

BLDG 6901

FORT NOVOSEL AL 36362-5152

210-808-2837 FOB: Destination

W31NWX

PWS

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 Development Command (USAMRDC). USAARL is one of USAMRDC’s six research laboratories in the continental United States, responsible for planning and executing basic and applied medical research. USAARL is located at Fort Novosel, Alabama, the home of Army Aviation and the U.S. Army Aviation Center of Excellence (USAACE). USAARL will be the proponant for this IDIQ, but this ordering vehicle will open to all Medical Research and Development Command (MRDC) research labs.

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 USAMRDC’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 Novosel, 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(s) shall provide the services necessary to assure the availability of whole body, cervical spines, lumbar spines, cephalus-T2, whole arms, and/or mid-femur to toe-tip specimens are available for military research into human tolerance to blunt impact accelerations for USAARL. 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 5NOV2019 and the USAMRDC Policy #78 “Use of Human Cadavers for RDT&E Education and Training” dated 3DEC2024, 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.

1.3.1. The Government intends on issuing a Multiple Awardee Indefinite-Delivery Indefinite-Quantity (IDIQ) for the services to acquire, screen, ship, and dispose of PMHS. All delivery orders will be issued by USAMRAA Contracting Officers or authorized Ordering Officers from USAARL. Delivery shall be made in accordance with paragraph 3.1.3 of this document; unless, otherwise specified in a delivery order.

1.4 Non-Disclosure Statement (NDS) (Deliverable 1, Attachment 01).

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.

1.5 Organization Conflict of Interest (OCI) (Deliverable 2, Attachment 02).

This contract will be used to procure USAMRDC 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.

SECTION 2 GENERAL REQUIREMENT

2.1. Performance

2.1.1. Place of Performance

2.1.1.1. Contractor(s) 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. Delivery Site. The PMHS work to be conducted is located on the USAARL campus 6901 Farrel Road and 8825 Andrews Avenue, Fort Novosel, AL 36362. The Delivery Order or purchase request will identify the building location for delivery.

2.1.2. Period of Performance. This contract is for a period of 5 years. 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 (CO) immediately.

2.3 Contract Management

2.3.1. Government Management. The Contracting Officer’s Representative (COR) for this contract will be appointed by the Contracting Officer (CO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract.

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 CO 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.

2.3.3. 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. Reserved.

2.5. Training Requirements (Not Applicable)

2.6. Government Work Days and Hours

2.6.1. Contractor personnel shall perform services during regular duty hours. Duty hours range from 0800 to 1800 hours, Monday through Friday.

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

2.6.2.1. 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:

2.6.2.1.1. New Year’s Day, 1 January

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

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

2.6.2.1.4. Memorial Day, last Monday in May

2.6.2.1.5. Juneteenth, 19 June

2.6.2.1.6. Independence Day, 4 July

2.6.2.1.7. Labor Day, 1st Monday in September

2.6.2.1.8. Columbus Day, 2nd Monday in October

2.6.2.1.9. Veteran’s Day, 11 November

2.6.2.1.10. 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 on days the Government or installation is closed due to local determinations relating to safety conditions, inclement weather conditions, national emergencies, energy conservation.

2.7. Travel (Not Applicable)

SECTION 3 PERFORMANCE REQUIREMENTS

3.1 PMHS Services

This section specifies the Performance Objectives and Performance Elements for the contract. The contractor(s) 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). The contractor shall be familiar with and comply with all federal and state laws applicable to these services. All PMHS specimens will be from fresh frozen, un-embalmed donors. PMHS specimens shall meet at a minimum the inclusion-exclusion criteria described in 3.1.1.1. and 3.1.1.2. 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 5NOV2019 and the USAMRDC Policy #78 “Use of Human Cadavers for RDT&E Education and Training” dated 3DEC2024, specifically:

The contractor shall ensure all State and U.S. territory laws and regulations applicable to/that govern the use/or transport of cadavers are followed.

The contractor shall obtain and maintain written authorization from individual/self-donor or next of kin for any Army conducted or supported use of human cadavers.

If donor authorization will be obtained by a third party or subcontractor, the Government must be notified of the responsible organization obtaining donor authorization.

The contractor shall provide the Government with copies of written donor authorizations for each supplied cadaver upon request and/or make available for inspection.

Use of unclaimed bodies or donations from medical examiners or coroners are not permitted.

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.

Table 1. PMHS Anatomy

PMHS Anatomy

Whole body minus hand or foot

Head to T2

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 4) 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 pre-acceptance medical imaging (Deliverable 5) of the research anatomical area of interest, Anterior-Posterior and Lateral, at a minimum. The Government will communicate the type of imaging required and the research anatomical area of interest.

3.1.2.3. The COR, or appointed Government representative, will review the medical imaging 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 or certificate of compliance (Deliverable 6) 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 7) 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

3.1.3.1 Shipments made under this agreement be accompanied by delivery tickets or sales slips that contain the following minimum information:

a. Name of supplier

b. IDIQ number

c. Date of purchase

d. Purchase (delivery order) number

e. Itemized list of PMHS anatomy description, donor number, quantity (as necessary), unit price, and extension of each item

f. Date of delivery

3.1.3.2. The deliverable services ordered under this contract are deliverable to Bldg 6901 Farrel Road or Bldg 8825 Andrews Avenue, Fort Novosel, 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. The specimen will remain frozen from receipt through final acceptance or rejection and return shipping.

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 8). The COR will coordinate shipments with the Contractor. The COR will ensure each specimen is labeled appropriately. 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 9). 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 – MONTHLY TRACKING. The Contractor will provide a monthly tracking (Deliverable 10) of quantity and anatomical description of tissue requested; quantity, donor number, and date of tissue accepted for use by the Government; and quantity, donor number, and date of tissue returned for final disposition.

3.1.8. Objective 8 – SITE VISITS. The Contractor will allow the Government (USAMRDC Office of Human and Animal Research Oversight [OHARO]) to visit Contractor facilities to ensure compliance with the Army Cadaver Policy requirements. The OHARO may review copies of relevant records and/or conduct on-site assessments. Site visits will be scheduled in advance with the Contractor.

3.2. While tissue is in the custody of the Government, the Government will:

3.2.1. Maintain the original donor identifying tag with the tissue at all times. Depending on the location of the tag, the tag may have to be removed from the specimen due to testing requirements. The tag will be kept in the storage container or bag with the tissue.

3.2.2. Maintain dissected tissue extraneous to the test, e.g. skin, IAW Contractor policies and procedures, so that all expected tissue is returned with the specimen for final disposition.

3.2.3. Capture still and moving (video) images for scientific documentation and analysis IAW the regulatory approved-protocol. Images and video are not shared outside of the approved-protocol team membership. Images may be redacted/cropped/altered as necessary to document scientific research findings in peer-reviewed reports and journals (e.g. zoom in image of fracture). Images will be carefully reviewed to ensure any identifying features of the donor are removed and donor dignity is respected.

3.2.4. Contact the Contractor to request permission for change of use or subsectioning of tissue prior to any such actions. For example, tissue that was requested, shipped, and accepted for project A is no longer needed; however, the same tissue could be used for project B. The Government will request permission to use the donor tissue for project B to ensure the test is within the donor’s consent.

3.2.5. Fix components with hardware in resin for potting in specific test scenarios. These scenarios will be described in the request for tissue. The components will be returned to the Contractor for final disposition in the resin with fixturing hardware to minimize complete disruption to the tissue.

3.3. Performance Requirement Summary Matrix

3.4. 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 (Not Applicable)

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 1 week 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. (None)

6.3. Mandatory Compliance

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.

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

7.1.6. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

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

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

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

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

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

7.1.12. 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)

QASP

Quality Assurance Surveillance Plan Post Mortem Human Subject (PMHS) Services

1. Purpose.

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

· What will be monitored?

· How Monitoring will take place?

· Who will conduct the monitoring?

· How monitoring efforts and results will be documented?

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. Government Roles and Responsibilities

a. Contracting Officer (CO) – The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

b. Contract Specialist (CS) – The CS shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CS shall also assure that the contractor receives impartial, fair, and equitable treatment under the contract.

c. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. At the conclusion of the contract or when requested by the CO, the COR shall provide documentation to the CO. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the CO for action.

d. Contracting Officer’s Technical Representative (COTR). A COTR is a Government employee who is authorized to monitor the contractor’s performance under the contract, serve as technical liaison between the contractor and the COR, and perform other duties specified in this document. COTRs have no authority to change any of the terms or conditions of the contract.

3. Contractor Representatives. The contractor’s identified employee shall serve as the contractor’s Program Manager and Task Manager for the contract.

4. Performance Standards. Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

The below Performance Requirements Summary Matrix includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL). If the performance standards are not met in the performance requirement summary the government will document the contractor’s past performance, and may terminate the contract in accordance with FAR Clause 52.212-4 (m), Termination For Cause.

5. Incentives. The Government shall use past performance as incentives. Incentives shall be based on exceeding, meeting, or not meeting performance standards.

6. Methods of Quality Assurance Surveillance.

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

Regardless of the surveillance method, the COR shall always contact the contractor's Program Manager and Task Manager when a defect is identified and inform the manager of the specifics of the problem. The COR, with assistance from the CS, shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard/AQL.

a. Direct Observation. Can be performed periodically or through 100% surveillance.

· Periodically

b. Periodic Inspection. Uses a comprehensive evaluation of selected outputs. Inspections may be scheduled [Daily, Weekly, Monthly, Quarterly, or annually] or unscheduled, as required.

· As requested or required.

c. 100% Inspection. Evaluates all outputs. Most applicable to small quantity, but highly important services. May be used where there are written deliverables and stringent requirements such as tasks required by law, safety, or security.

· Provide reports and documentation as specified in the PWS and the Performance Requirements Summary Matrix above.

d. Progress or status meetings.

Surveillance results may be used as the basis for actions (to include payment deductions) against the Contractor. In such cases, the Inspection of Services clause in the Contract becomes the basis for the CO’s actions

7. Ratings. Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used: