Call 1 - JMCIP - Attachment 1 Statement of Objective(s) (SOO).pdf

STATEMENT OF OBJECTIVES

Hybrid Broad Agency Announcement, Airman Readiness Medical Research (ARMR) Call 1

Joint Multi-Channel Infusion Pump (JMCIP)

18 February 2022

1.0 BACKGROUND

The Joint Service lacks a permanent MCIP system that is FDA approved, reliable, maintainable, and capable of infusing multiple IV fluids, medications, nutrition, and blood for patients across the operational continuum of care. The JMCIP will provide infusion channels for the simultaneous delivery of a wide range of fluids from various mediums. Each line will have the capability to deliver a separate drug, eliminating incompatibility and drug sequencing limitations. The JMCIP will have pre-set factors that accommodate specific clinical applications to include pediatric, operating room, critical care and secondary infusion capabilities for the expeditionary and en route care systems. The purpose of the JMCIP ARMR effort is to demonstrate this MCIP capability in a prototype device.

2.0 SCOPE

The objective of the ARMR JMCIP project is to develop and demonstrate a prototype JMCIP medical device that meets as many of the requirements stated in the government System Requirement Document (SRD) Requirements List as feasible in order to demonstrate the vendor’s capability to produce an FDA-approved JMCIP device. The Government anticipates a separately contracted effort for further development toward delivery of a Safe-to- Fly/Airworthiness certified, FDA-approved JMCIP device.

3.0 TASKS / TECHNICAL AREAS / OBJECTIVES

Under this Call, 711 HPW/RHB will be procuring the development of prototypes and the testing of fully functional JMCIP devices. The contractor shall deliver three prototype devices and the related supporting hardware including administration sets and Contract Data Requirements List (CDRL) documentation.

3.1 The contractor shall design, develop and fabricate functional prototypes, including administration sets, to address all the Project-Unique Identifier (PUI) requirements listed in the JMCIP Requirements List (attached).

3.2 The contractor shall demonstrate that the prototype, at the minimum, is capable of meeting the following JMCIP requirements through demonstration and test:

PUI #2 Multi-channel infusion capability with at least three channels in one device

FA8650-20-S-6008, Call 1 Attachment 1 - Statement of Objectives (SOO)

18 February 2022

Volume to be infused PUI #9 Selectable infusion rate for each channel PUI #11 Flow rate accuracy PUI #14 A/C powered operations PUI #18 Pump operation orientation PUI #30 Fluid elevation PUI #31 Battery powered operations PUI #34 Battery replacement PUI #38 Weight PUI #39 Size PUI #40 Noise level PUI #46 Operable by personnel wearing personal protective equipment

PUI #47

3.3 The contractor shall develop and submit a Test Plan/Procedure (CDRL A007 Test Plan) for this effort. All demonstrations and testing shall be conducted at the contractor’s facility. The Government intends to witness the testing events at the contractor’s facility. The contractor shall provide the Government a Final Test Report (CDRL A009 Test/Inspection Reports) documenting the results.

3.4 The contractor shall deliver three devices and 30 administrations sets and shall develop and deliver draft Preliminary Operator Instructions for Government’s evaluations (CDRL A008 Preliminary Operator’s Manual).

3.5 The contractor shall provide an initial Design review approximately 45 days after contract award to obtain government concurrence on the proposed design approach and a Final Design Review prior to fabricating the prototype devices used for test and demonstration (A006 Presentation material).

4.0 Program Management

4.1 The contractor shall implement an effective program management structure to ensure task order accomplishment as specified, on schedule, and within budget. The contractor shall prepare and submit a Funds and Man-hour Expenditure Report (CDRL A002 Funds and Man Hour Expenditure Report), a Contract funds Status Report (CDRL A003 Contract funds Status Report) and a Project Planning Chart (CDRL A004 Project Planning Chart).

4.2 The contractor shall provide recurring status reports, which identify accomplishments to date, difficulties encountered, and compares the status achieved to planned goals. Identification of problems/deficiencies shall include known or anticipated impact, and the contractor shall provide recommended solutions (CDRL A005 Status Report).

4.3 The contractor shall provide a Final Report at the end of the technical effort (CDRL

A001 Final Report).

FA8650-20-S-6008, Call 1

5.0 SECURITY REQUIREMENTS

5.1 Position of Trust. All Contractor personnel require a minimum of a Tier 1 background check (T1)/SF85 for any position that requires access to the internet, use of automated information systems to cover standalone computers, or unescorted entry into restricted or controlled areas prior to reporting for duty in support of any requirement. The investigation is not for a security clearance; it is for a position of trust. This is a mandatory requirement set forth in DoDM 5200.02_AFMAN 16-1405, Air Force Personnel Security Program. All documentation required for security certification shall be the responsibility of the Contractor.

5.2 Operations Security (OPSEC). The contractor shall provide OPSEC protection for all sensitive/critical information and indicators involved in execution of this contract/Task Order, as defined by AFI 10-701 (Operations Security). 711 HPW Critical Information and Indicators are protected under the 711 HPW Operations Security Program and the 711 HPW Critical Information and Indicators List (CIIL). Contractor employees granted access to critical information and indicators will be provided initial OPSEC training by the 711 HPW OPSEC Coordinator upon in-processing and prior to being granted access to CIIL items related to the contract/Task Order. The contractor will also participate in 711 HPW’s annual OPSEC training and education programs, which includes periodic updates and refresher training on CIIL items applicable to the contract/Task Order. The 711 HPW OPSEC coordinator will evaluate the OPSEC posture of AF contract activities and operations.

5.3 Information Security and Force Protection. The Contractor shall accomplish

Information Security and Force Protection training as defined by AFI 16-1404, Air Force Information Security Program, and DoDIO- 2000.16V1_AFI10-245-O_AFMCSUP, Antiterrorism (AT) Program Implementation. The Contractor shall participate in the 711 HPW sustained Information Security and Force Protection/Antiterrorism training, or include this training as part of their ongoing security program. The 711 HPW Security Managers will evaluate the training posture of AF contract activities and operations. This requirement is set forth in AFI 16-1404, DoDIO- 2000.16V1_AFI10-245-O_AFMCSUP, and applicable AFRL and 711 HPW supplements.

5.4 The contractor must comply with all federal, state and local safety and environmental regulations.

5.5 An approved Safety Plan IAW AFI 91-202 AFRL Supplemental 1 is required before any experiment may be conducted. The contractor must comply with all Air Force safety and environmental regulations.

5.6 The contractor shall comply with system safety requirements constrained in MIL-

STD 882E, Section 4 “General Requirements” for any deliverable systems or hardware. The contractor shall identify safety- critical components of those systems or hardware, and software interfaces with those components. The contractor shall test and verify the safety-critical hardware and software for safety acceptance.

FA8650-20-S-6008, Call 1

5.7 Any flight activities must be coordinated and approved by HQ AFRL/SE.

5.8 Protection of Human Subjects and Use of Live Animal Subjects. This research will not involve the use of live animal subjects or the use of human subjects.

5.9 Highest Security Classification: Unclassified.

FA8650-20-S-6008, Call 1