20-R-0021-P00001 Conf Copy 5-4-20.pdf

CODE

(Hour)

PAGE(S)

until local time

X

A X B X C

D

EX

X G F 84 - 92

93 - 105 H 106 - 112

PETER.D.MITCHELL8.CIV@MAIL.MIL

RATING PAGE OF PAGES

7. ISSUED BY

(Date)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

Previous Edition is Unusable 33-134 STANDARD FORM 33 (REV. 9-97)

Prescribed by GSA FAR (48 CFR) 53.214(c)

1 112

(If other than Item 7)

15A. NAME 16. NAME AND TITLE OF PERSON AUTHORIZED TO

AND

ADDRESS

SIGN OFFER (Type or print)

OF

OFFEROR

AMENDMENT NO. DATE

15B. TELEPHONE NO (Include area code) 17. SIGNATURE15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

18. OFFER DATE

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

2. CONTRACT NO.

W81XWH 8. ADDRESS OFFER TO

See Item 7

9. Sealed offers in original and 1 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME (NO COLLECT CALLS)

PETER MITCHELL 301-619-1355

11. TABLE OF CONTENTS

SOLICITATION/ CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/ COSTS

1 - 2 3 - 7

X I CONTRACT CLAUSES

DESCRIPTION/ SPECS./ WORK STATEMENT

PACKAGING AND MARKING

8 - 17 J LIST OF ATTACHMENTS

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

19 - 32

X K

REPRESENTATIONS, CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS

CONTRACT ADMINISTRATION DATA 33 - 35 X

SPECIAL CONTRACT REQUIREMENTS

OFFER (Must be fully completed by offeror) X M

L INSTRS., CONDS., AND NOTICES TO OFFERORS

EVALUATION FACTORS FOR AWARD

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52.232-8)

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments

AMENDMENT NO. DATE

to the SOLICITATION for offerors and related documents numbered and dated):

FACILITY

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period

SOLICITATION, OFFER AND AWARD

X

(X) SEC. DESCRIPTION (X) SEC. DESCRIPTION PAGE(S)

PART I - THE SCHEDULE

26. NAME OF CONTRACTING OFFICER (Type or print) 27. UNITED STATES OF AMERICA 28. AWARD DATE

EMAIL:TEL: (Signature of Contracting Officer)

CODE CODE

B. TELEPHONE (Include area code) C. E-MAIL ADDRESS

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) (4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE

PART IV - REPRESENTATIONS AND INSTRUCTIONS

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

36 - 83

PART II - CONTRACT CLAUSES

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

FAX:

TEL:

FAX:

TEL:

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

6. REQUISITION/PURCHASE NO.

0011423032

5. DATE ISSUED

27 Apr 2020

4. TYPE OF SOLICITATION

SEALED BID (IFB)

NEGOTIATED (RFP)

[ X ]

3. SOLICITATION NO.

W81XWH20R0021

Section A - Solicitation/Contract Form

GENERAL INFORMATION

Project Title: Warfighter Health, Performance and Evacuation Project Management Office, Transport Telemedicine Systems Automated IV Pressure Infuser for MEDEVAC

This is a Request for Proposal (RFP)/solicitation for a Research & Development (R&D) requirement. This RFP/solicitation is for Full and Open Competition –Best Value Tradeoff under the authority of FAR 6.102(b) – Competitive proposals.

The Government anticipates that any resulting award from the RFP/solicitation will be a Cost-Plus-Fixed-Fee (CPFF) contract.

The anticipated period of performance (POP) is Fifty-four (54) months.

The resultant award will be a 100% small business set aside.

*REVISED in AMENDMENT #1 5-4-20

North American Industry Classification System (NAICS) Code: 541714— Research and Technology in Biotechnology (Except Nano biotechnology) Product Service Code: AN93—R&D-Other Medical (Advanced Development)

Point of Contact (POC): The primary point of contact (POC) for this solicitation is Peter D. Mitchell, Contract Specialist, peter.d.mitchell8.civ@mail.mil. All inquiries regarding this requirement must be submitted via electronic mail (e-mail) to the Contract Specialist.

Proposal Submission: Proposals shall only be electronically submitted to the primary POC via e-mail, No later than 29 May 2020 at 1:00 PM Eastern Time. The e-mail must have a subject title of “W81XWH-20-R-0021 Proposal Submission”. The Offeror is responsible for verifying receipt by the POC. One electronic copy shall be submitted for each proposal volume. Each proposal volume should be a separate attachment.

The Government anticipates that this solicitation will result in one (1) contract award.

This invitation to submit a proposal does not assure that a contract will be awarded.

(End of general information)

Section B - Supplies or Services and Prices

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Job Design Refine/Iterative Tech Prototype

CPFF

Warfighter Health, Performance and Evacuation Project Management Office, Transport Telemedicine Systems FOB: Destination

PURCHASE REQUEST NUMBER: 0011423032

PSC CD: AN93

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

0002 1 Job OPTION Optional Task 1 - Risk Manag and Air Rel

CPFF

Optional Task 1 - Obtain Risk Management Framework and Airworthiness Release Certifications FOB: Destination

0003 1 Job OPTION Optional Task 2 - FDA Reg and Cert

CPFF

Otional Task 2 - FDA Class I Registration and Certifications

0004 1 Job OPTION Optional Task 3 - LRIP

CPFF

Optional Task 3 - Low Rate Initial Production (LRIP)

0005 1 Each Other Direct Costs - ODCs

COST

Other Direct Costs for travel and miscellaneous supplies.

0006 1 Each Contractor Manpower Reporting (CMR)

FFP

Contractor shall input information in accordance with requirement "Contractor Manpower Reporting (CMR)" in section C.

NET AMT

0007 1 Each

CDRL A001 - CWBS

CPFF

CDRL A001-Contract Work Breakdown Structure (CWBS)

0008 1 Each

CDRL A002 - IMS

CPFF

CDRL A002-Integrated Master Schedule (IMS)

0009 1 Each

CDRL A003 - PMP

CPFF

CDRL A003- Program Management Plan (PMP)

0010 1 Each CDRL A004 - Master Gov Property List

CPFF

CDRL A004- Master Government Property List

0011 1 Each CDRL A005 - Final Report(s)

CPFF

CDRL A005- Final Report(s)

0012 1 Each CDRL A006 - Tech Data Package

CPFF

CDRL A006- Technical Data Package, System Specifications, Technical Manuals, and Quick Guides

0013 1 Each CDRL A007 - FDA Sub Package

CPFF

CDRL A007- FDA Submission Package

Section C - Descriptions and Specifications

STATEMENT OF OBJECTIVES (SOO)

STATEMENT OF OBJECTIVES

Original Date: 11/6/2019 Revised Date: 4/16/20 Title: Automated Intravenous (IV) Pressure Infuser Requiring Activity/Agency Name: Warfighter Health, Performance and Evacuation Project Management Office, U.S. Army Medical Materiel Development Activity Program Name: Transport Telemedicine Systems

1. PURPOSE/OBJECTIVE

Current standard of care practices in Army medicine utilize pressure infusion bags to provide rapid infusion of blood or other fluids into patients. However, pressure infusion bags require the medic to manually pressurize the bag by pumping a bulb. During a medical evacuation (MEDEVAC) mission, the manual burden necessary to pressurize the bag detracts the medic from their mission to perform life-saving measures to injured Warfighters. The purpose of this SOO is to obtain First Article Testing prototype(s) for an automated IV Pressure Infuser that will apply multiple options of pressure settings to IV fluids and wirelessly communicate the IV bag characteristics to a commercial tablet, allowing a medic to monitor and control the IV bag with minimal hands-on effort.

An additional goal of the automated IV Pressure Infuser is to integrate the device with the Medical Hands-Free Unified Broadcast (MEDHUB) system. MEDHUB currently integrates commercially available FDA devices, novel non-medical devices, and automated (hands-free, voice-free) software in order to capture Tactical Combat Casualty Care (TC3) card information. This data is transmitted over the DoD tactical satellite network to receiving Medical Treatment Facilities where it displayed in a standard hospital Intensive Care Unit (ICU) dashboard format.

2. BACKGROUND

The Department of Defense (DoD) Form 1380 (TC3 Card) is the “Gold Standard” and the current solution for documentation for all medical evacuations within the DoD; however, the current documentation process during MEDEVAC operations is limited due to the labor intensive manual process and the extensive time required to document care. Medics lack the capability to document patient care in a hands-free manner while performing patient treatment. Most of the documentation that occurs is either transcribed on bandages or completed after the mission and is limited to what the medic remembers. Upon arrival to a Role of Care II or III facility, only 14% of casualties arrive with prehospital documentation of care, as of 2011. Current medical documentation processes do not support medical situational awareness at the deployed Field Hospital because there is a lack of capability to capture, store, and forward patient data to the receiving deployed Field Hospitals during evacuation missions

MEDHUB Increment 1 addresses the need for an integrated, modular, and adaptable near-real-time telemonitoring system to increase situational awareness for deployed Field Hospitals and provide continuous monitoring of critical care patients within a theatre of operations while reducing documentation burden to the medic. MEDHUB Increment 1 utilizes only FDA-approved devices. It is currently in development and is scheduled to be fielded to Army units in 2021.

MEDHUB Increment 2 focuses on further decreasing medic burden by developing novel medical devices that increase the automation of patient care. The development effort described in this SOO is part of MEDHUB Increment 2.

During MEDEVAC missions, medics may need to rapidly infuse patients with blood products or other fluids.

Pressure infusion bags offer a means to rapidly decrease the amount of time necessary to infuse fluids compared to gravity-fed fluids; however, these pressure infusion bags require a significant amount of medics’ time and attention to setup and monitor. During a mass casualty scenario, the medic is expected to manage up to six (6) patients, and the time required to configure a pressure infusion bag is detrimental to the medic’s mission. An engineered solution is needed that can automatically control the pressure applied to a fluid bag and monitor the infusion levels with minimal burden to the medic. In addition, the device must be capable of operating in a high noise, low visibility, high vibration, and altering altitude environment that accompanies MEDEVAC missions.

3. SCOPE OF EFFORT

The Transport Telemedicine Systems is pursuing developmental efforts to create an automated IV Pressure Infuser that increases the automation in the Army’s current use of pressure infusion bags by fulfilling the requirements detailed below. At the end of the developmental effort, a Technology Readiness Level (TRL) of 8 is required (See Appendix A). The final form of the technology shall be demonstrated to function properly under expected operating conditions.

The Contractor shall draft a Statement of Work (SOW) for the development of the automated IV Pressure Infuser.

The SOW shall include all activities required for design, development, testing, Army Materiel Release, Airworthiness Release, Authority to Operate (ATO) on a military network, production, training, and fielding. The Contractor shall provide a SOW with well thought out approach and rationale to Warfighter Health, Performance and Evacuation (WHPE) Project Management Office (PMO) for each proposed Contract Line Item Number (CLIN).

The WHPE PMO will perform audits as deemed required or necessary and reserves the right to seek any contractual remedy available to it.

3.1. Technical Requirements

Threshold (minimum requirements):

a. Shall provide two pressure settings: 300 mmHg (Bolus) and 50 mmHg (TKO-to keep open) of pressure to IV fluids without the use of hand pump(s).

b. Shall have indication to communicate when IV fluid bag is full, when there are three minutes left before IV fluid bag is empty, and when the IV fluid bag is empty.

c. Shall be able to load IV Pressure Infuser system with fluids, pressurize, and begin delivery of fluids correctly in two minutes or less.

d. Shall be compatible for use on standard IV bags and IV tubing.

e. Shall be compatible with 500 mL IV fluid bags, 1000 mL IV fluid bags, and one unit of blood product bags.

f. Shall be compatible with current blood warming technology (Thermal Angel, Buddy Lite).

g. Shall be capable of operating in Army air and ground ambulances.

h. Shall be fully functional while changing altitude (sea level to 14,000 feet above sea level).

i. Shall meet airworthiness certification (see Appendix C) and comply with DoD Information Assurance protocols (DISA Risk Management Framework), current Federal Information Processing Standards (see Appendix D), and FDA medical device clearance as necessary.

j. Shall communicate the estimated bag size, infusion start time, infusion stop time, and estimated time until empty via Bluetooth 4.1 or higher to Samsung tablets and phones on an android operating system.

k. Shall be attachable to an Army Special Medical Emergency Evacuation Device (SMEED).

l. Shall maintain proper pressure setting in absence of power supply.

Objective (desired) requirements:

a. Shall provide warmed blood products using a standalone warming option on the system.

b. Shall communicate the estimated flow rate via Bluetooth 4.1 or higher to Samsung tablets and phones on an android operating system.

3.2 Development Levels

Upon completion of all periods of performance, if granted, the product is expected to complete Low Rate Initial Production (LRIP) and achieve a minimum TRL of 8.

4. PLACE AND PERIOD OF PERFORMANCE

The estimated period of performance is:

Base Period Date of award through 18 months of performance

Option Period 1 2 months prior to expiration of Base Period through 14 months of performance

Option Period 2 2 months prior to expiration of Option Period 1 through 8 months of performance

Option Period 3 2 months prior to expiration of Option Period 2 through 14 months of performance

The Offeror is to determine the place of performance in its Technical proposal.

5. Specific Taskings:

5.1 Base Period: Design Refinement and Iterative Technology Prototyping. The Base Period shall be used for continual refinement of the product. Feedback shall be given and continued refinement of the device shall be conducted, resulting in the delivery of a fully integrated and successfully tested system that can perform the program requirements. This phase is anticipated to last 18 months.

Tasks:

5.1.1. Complete Initial Baseline Review (IBR). The IBR shall include discussions regarding the Integrated Master Schedule (IMS), Work Breakdown Structure (WBS), performance specifications, Quality Assurance Plan, and the SOW that encompasses the entire scope of the contract based on this Government-provided SOO. The IMS should include major milestones and be directly traceable to the SOO. The IBR shall be conducted within one month (30 calendar days) of contract award.

5.1.2. Initial Prototypes, Developmental Testing (DT), and User Assessment. The contractor shall design and build (4) prototypes in accordance with SOW, performance specifications, and Quality Assurance Plan with a TRL of 5. The Contractor shall deliver all four (4) initial prototypes to the Government, including any consumables. The contractor shall support developmental testing and user assessments.

5.1.3. Critical Design Review and Prototyping. The contractor shall create a Critical Design Review (CDR) Product Master Data File (PMDF) that includes system design, architecture, technology selection criteria assessments, and performance specifications. The contractor shall design and build six (6) prototypes with a TRL of 6 in accordance with the CDR, SOW, performance specifications, and quality assurance plan.

5.2. Optional Task 1: Obtain Risk Management Framework and Airworthiness Release Certifications

Tasks:

5.2.1. Risk Management Framework, Airworthiness Release, and User Assessment. Obtain Airworthiness Release, medical device ruggedness testing, and an Authority to Operate (ATO) through the DoD Risk Management Framework (RMF). Complete and support additional user assessments. The SOW shall include how the contractor plans to meet the Airworthiness Release requirements for a rotary wing aircraft (see Appendix C).

5.3. Optional Task 2: FDA Class I Registration and Certifications

5.3.1. FDA Class I Registration. The Contractor shall register the device with the FDA as a Class I (general controls) product and be in compliance with the general controls that apply to Class I medical devices.

5.4 Optional Task 3: Low Rate Initial Production (LRIP) and First Article Testing (FAT)

5.4.1. LRIP and FAT. The contractor shall manufacture and deliver thirty-three (33) systems, along with the following:

a. New Equipment Training (NET)

b. Bill of Materials (BOM) for all systems and subsystems

c. Repair parts list with associated commercial part numbers and manufactures

d. List of required test, measurement, and diagnostic equipment (TMDE)

e. Quick user guides

f. Technical user manual

g. Technical operator manual (including maintenance plan and maintenance schedule)

Complete FAT on a production system based on Quality Assurance Plan for production units.

5.4.2. FDA Updates. The contractor shall file any updates to the FDA as necessary if changes occur to the product.

The contractor must be in Good Manufacturing Practices (GMP) compliance (per 21 CFR Part 820).

6. TRAVEL

The Contractor shall be required to travel to the U.S. Army Medical Materiel Development Activity at Fort Detrick, Maryland or other government sites for product demonstrations and/or technical meetings and/or product testing at least once, but no more than twice, during the period of performance.

7. CONSTRAINTS

The Contractor shall sign and submit a Non-Disclosure Statement (Appendix B) on behalf of the company and shall also ensure that all staff assigned to, including all subcontractors and consultants, or performing on this task order execute 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 have not executed this statement or failure to adhere to this statement may constitute default on the part of the Contractor.

7.1 CONTRACTOR MANPOWER REPORTING (CMR) – ACCOUNTING FOR CONTRACT SERVICES (APR

2011) (U.S. ARMY MEDICAL RESEARCH ACQUISITION ACTIVITY)

The Office of the Assistant Secretary of the Army (Manpower and Reserve Affairs) operates and maintains a secure Army data collection site where the contractor will report ALL contractor manpower (including sub-contractor manpower) required for performance of this contract. The contractor is required to completely fill in all the information in the format using the following web address: https://cmra.army.mil. The required information includes: (1) Contract Number; (2) Delivery Order Number (if applicable); (3) Task Order Number (if applicable);

(4) Requiring Activity Unit Identification Code (UIC); (5) Command; (6) Contractor Contact Information; (7) Federal Service Code (FSC); (8) Direct Labor Hours; (9) Direct Labor Dollars; and, (10) Location. In the event the Contracting Officer's Representative (COR)/Contracting Officer's Technical Representative (COTR) has not entered their data requirements first, the contractor must also enter the COR/COTR required data with the exception of fund cite, obligations, and disbursement data. The CMRA help desk can be reach at 703-695-5103 or 703-695-5058 for any technical questions. The help desk can also be contacted via email: contractormanpower@hqda.army.mil. As part of its quote or offer, the contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement. The reporting period will be the period of performance not to exceed 12 months ending 30 September of each government fiscal year and must be reported by 31 October of each calendar year.

7.2 Access and general protection/security policy and procedures. Contractor and all associated sub-contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office.

Contractor workforce must comply with all personal identity verification requirements (Federal Acquisition Regulation (FAR) clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by Department of Defense, Headquarters, Department of the Army 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.

7.3 For contractors that do not require a Common Access Card (CAC), but require access to a DOD facility or installation. Contractor and all associated sub-contractor employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database 9TSDB) (Army Directive (AD) 2014-05/Army Regulation (AR) 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or at Outside Continental United States (OCONUS) locations, in accordance with status of forces agreements and other theater regulations.

Accessing the Fort Detrick Installation Fort Detrick and the Army are committed to ensuring the safety of the post and its personnel. All visitors will be vetted through the National Crime Information Center Interstate Identification Index (NCIC-111) before entering Fort Detrick. All visitors MUST enter through the Nallin Gate and the Visitor Control Center (VCC). Visitors need one of the following:

a. Valid state driver’s license or identification card

b. Locally issued installation badge and/or pass

c. DA Form 1602, Civilian Identification and Gold Star Family

d. School District Employees ID (only until the installation has a local produced badge)

e. The Transportation Security Agency (TSA) issued Transportation Worker Identification Credential (TWIC)

f. DD Form 2574, Armed Forces Exchange Services ID and Privilege

g. Air Force (AF) Form 354, Civilian ID

h. DD Form 1934, Geneva Convention ID card for Medical and Religious

i. DD Form 2764, US DOD/Uniformed Services Civilian Geneva Convention ID

j. DD Form 489, Geneva Convention ID card for Civilians

k. Valid U.S. passport

Everyone, especially the driver in the vehicle must present a valid ID such as CAC, DOD issued ID, or State issued ID card, so please have them readily assessable, (not in card holder or wallet with plastic window). Be sure Installation ACP Guards can visually see inside your entire vehicle in order to validate that all persons inside the vehicle have presented valid credentials. This might require the back passenger windows to be rolled down for taller vehicles and or darker tinted windows. The guard will physically take possession of your ID cards in order to validate the photo to the person and observe the front and back for tampering.

The vetting process for an individual is done on the spot and is completed the same day. The time to complete the process depends on the number of names submitted to the Installation Badge Office for clearance. There is a multitude of reasons that could deny access. Some of those include:

a. The individual has a current arrest warrant

b. The individual is currently barred from entry or access to a federal installation or facility

c. The individual has been convicted of crimes encompassing sexual assault, armed robbery, rape, child molestation, production or possession of child pornography, trafficking in humans, drug possession with intent to sell or drug distribution

d. The individual has been convicted of a felony within the past 10 years, regardless of the offense or violation

e. The individual has been convicted of a felony firearms or explosives violation

Pre-vetting can be completed by providing the information requested on Form 190-13, to be provided after contract award. The following information is required for the form:

a. Name (First, MI, Last)

b. Social Security Number

c. Driver License Number

d. Address

e. City

f. State

g. Zip Code

h. Date of Birth

i. Place of Birth

j. Organization Building Number

k. Contract Expiration Date

Appendix A.

DOD DESKBOOK 5000.2-R

APPENDIX 6

TECHNOLOGY READINESS LEVELS AND THEIR DEFINITIONS

TECHNOLOGY READINESS LEVELS

The following matrix lists the various technology readiness levels and descriptions from a systems approach for both HARDWARE and SOFTWARE. DoD Components may provide additional clarifications for Software.

Supplemental definitions follow the table.

Technology Readiness Level Description

1. Basic principles observed and reported.

Lowest level of technology readiness. Scientific research begins to be translated into applied research and development. Examples might include paper studies of a technology’s basic properties.

2. Technology concept and/or application formulated.

Invention begins. Once basic principles are observed, practical applications can be invented. Applications are speculative and there may be no proof or detailed analysis to support the assumptions. Examples are limited to analytic studies.

3. Analytical and experimental critical function and/or characteristic proof of concept.

Active research and development is initiated. This includes analytical studies and laboratory studies to physically validate analytical predictions of separate elements of the technology. Examples include components that are not yet integrated or representative.

4. Component and/or breadboard validation in laboratory environment.

Basic technological components are integrated to establish that they will work together. This is relatively “low fidelity” compared to the eventual system. Examples include integration of “ad hoc” hardware in the laboratory.

5. Component and/or breadboard validation in relevant environment.

Fidelity of breadboard technology increases significantly. The basic technological components are integrated with reasonably realistic supporting elements so it can be tested in a simulated environment. Examples include “high fidelity” laboratory integration of components.

6. System/subsystem model or prototype demonstration in a relevant environment.

Representative model or prototype system, which is well beyond that of TRL 5, is tested in a relevant environment. Represents a major step up in a technology’s demonstrated readiness. Examples include testing a prototype in a high-fidelity laboratory environment or in simulated operational environment.

7. System prototype demonstration in an operational environment.

Prototype near, or at, planned operational system. Represents a major step up from TRL 6, requiring demonstration of an actual system prototype in an operational environment such as an aircraft, vehicle, or space. Examples include testing the prototype in a test bed aircraft.

8. Actual system completed and qualified through test and demonstration.

Technology has been proven to work in its final form and under expected conditions.

In almost all cases, this TRL represents the end of true system development.

Examples include developmental test and evaluation of the system in its intended weapon system to determine if it meets design specifications.

9. Actual system proven through successful mission operations.

Actual application of the technology in its final form and under mission conditions, such as those encountered in operational test and evaluation. Examples include using the system under operational mission conditions.

DEFINITIONS:

BREADBOARD: Integrated components that provide a representation of a system/subsystem and which can be used to determine concept feasibility and to develop technical data. Typically configured for laboratory use to demonstrate the technical principles of immediate interest. May resemble final system/subsystem in function only.

“HIGH FIDELITY”: Addresses form, fit and function. High-fidelity laboratory environment would involve testing with equipment that can simulate and validate all system specifications within a laboratory setting.

“LOW FIDELITY”: A representative of the component or system that has limited ability to provide anything but first order information about the end product. Low-fidelity assessments are used to provide trend analysis.

MODEL: A functional form of a system, generally reduced in scale, near or at operational specification. Models will be sufficiently hardened to allow demonstration of the technical and operational capabilities required of the final system.

OPERATIONAL ENVIRONMENT: Environment that addresses all of the operational requirements and specifications required of the final system to include platform/packaging.

PROTOTYPE: A physical or virtual model used to evaluate the technical or manufacturing feasibility or military utility of a particular technology or process, concept, end item or system.

RELEVANT ENVIRONMENT: Testing environment that simulates the key aspects of the operational environment.

SIMULATED OPERATIONAL ENVIRONMENTAL: Either 1) a real environment that can simulate all of the operational requirements and specifications required of the final system, or 2) a simulated environment that allows for testing of a virtual prototype; used in either case to determine whether a developmental system meets the operational requirements and specifications of the final system.

Appendix B.

Non-Disclosure Agreement

APPENDIX C

Joint Enroute Care Equipment Test Standard https://www.usaarl.army.mil/pages/research/aced/documents/JECETS%20- %201Mar2012%20(PA%20approved).pdf

APPENDIX D

Federal Information Processing Standards https://www.nist.gov/itl/current-fips

Section E - Inspection and Acceptance

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 0004 Destination Government Destination Government 0005 Destination Government Destination Government 0006 Destination Government Destination Government 0007 Destination Government Destination Government 0008 Destination Government Destination Government 0009 Destination Government Destination Government 0010 Destination Government Destination Government 0011 Destination Government Destination Government 0012 Destination Government Destination Government 0013 Destination Government Destination Government

CLAUSES INCORPORATED BY REFERENCE

52.246-8 Inspection Of Research And Development Cost

Reimbursement

MAY 2001

Section F - Deliveries or Performance

DELIVERABLES /CDRLS

Original Date: 11/19/2019

Revised Date: 4/16/20

Title: AUTOMATED INTRAVANEOUS (IV) PRESSURE INFUSER

This information will be incorporated into Section F of the awarded contract.

1.0. General Deliverable Information

Delivery Address: All deliverables shall be submitted to the COR designated in the COR appointment letter.

Method of Delivery: Electronic copies shall be delivered using Microsoft Office suite of tools (for example, MS WORD, MS EXCEL, MS POWERPOINT, MS PROJECT, or MS ACCESS format) or in Adobe PDF format, unless otherwise specified by the COR. Electronic submission shall be made via email, unless otherwise agreed to by the COR. <Note: Some contract deliverables may be required to be submitted in Contract Data Requirement List (CDRL) format. If your requirement calls for data as a deliverable, specify additional CDRL delivery requirements here.>

Shipping: The Contractor shall use appropriate, cGMP-compliant refrigerated shipping carriers for drug product shipments (FedEx, World Courier, or similar, as agreed to by the COR), and appropriate shipping methods for all other materials, equipment, and hard copy documents. In the United States, the contractor shall use the US Postal Service standard delivery for delivery of all such shipments.

Government Acceptance Period: The COR will have ten (10) business days to review draft deliverables and CDRLs and make comments if dates are not specifically provided. The Contractor shall have five (5) business days to make corrections. Upon receipt of the final deliverables, the COR will have two (2) workdays for final review prior to acceptance or providing documented reasons for non-acceptance. Should the Government fail to complete the review within the review period the deliverable will become acceptable by default, unless prior to the expiration of the ten (10) business days the Government notifies the Contractor in writing to the contrary. The final submission should be deemed approved if the Government has not rejected it in 30 calendar days.

The COR will have the right to reject or require correction of any deficiencies found in the deliverables that are contrary to the information contained in the Contractor’s accepted proposal. In the event of a rejected deliverable, the Contractor will be notified in writing by the COR of the specific reasons for rejection. The Contractor shall have five (5) business days to correct the rejected deliverable and return it per delivery instructions.

2.0. Deliverable/Delivery Schedule:

A summary of deliverables follows. Copies are to be provided to the Government officials indicated in electronic file (E) unless otherwise stated.

Deliverables Chart

Item Ref. Title Distribute

To Initial Subsequent Comments

Deliverable 1

SOO

Task 4.1

Contractor’s Progress, Status, and Management (PSM)

Report; Issue Summary Report

COR

No later than

(NLT) 45

calendar days after contract award

NLT 10th working day of each month of performance

At a minimum, shall address Man-Hours

Required, Funds Expended, Work

Completed, Program Cost Curves, Program

Risk Elements

Deliverable 2

SOO

Task 4.1

Annual In Process Review

COR

NLT 60

calendar days prior to end of Base Period

Annually

Deliverable 3

SOO

Task 4.1

Meeting Minutes from Meetings with

Government

COR

NLT 30

calendar days after contract award

Minimum twice a month

Deliverable 4

SOO

Task 4.1

Provide Configuration and

Change Management Revision Control

Document.

COR

NLT 45

calendar days after contract award

Monthly Incorporate into

Monthly Progress Report

Deliverable 5

SOO

Task 4.1.1

Provide Quality Assurance Plan

COR At IBR N/A

Deliverable 6

SOO

Task 4.1.1

Conduct Initial Baseline Review

(IBR)

COR

NLT 30

calendar days after contract award

N/A

Includes performance specifications, integrated master schedule, quality assurance plan and statement of work

(SOW). From now on all of these deliverables shall be called Program

Documentation.

Deliverable 7

SOO

Task 4.1.2

Design and build four (4) prototypes of

TRL of 5

COR

NLT six (6) months after contract award N/A

In accordance with SOW and minimum essential characteristics and all equipment and includes accessories required to demonstrate capability and maintain system.

Distribute

To Initial Subsequent Comments

Deliverable 8

SOO

Task 4.1.3

Provide an initial CDR Product Master

Data File (PMDF)

COR

7 calendar days prior to

CDR

execution

(Deliverable 11)

N/A

Includes system design, architecture, technology selection criteria assessments, and performance specifications.

Deliverable 9

SOO

Task 4.1.3

Conduct CDR Event & Report

COR

NLT 14

months after contract award

N/A

Deliverable

SOO

Task 4.1.3

Submit final CDR

PMDF

COR

14 calendar days after

CDR event (Deliverable

11)

N/A

Deliverable

SOO

Task 4.1.3

Design, build, and deliver six (6) prototypes of post- CDR systems

COR

NLT seven (7) calendar days prior to completion of Base Period

N/A

In accordance with SOW and minimum essential characteristics for TRL 6 validation and all equipment and includes accessories required to demonstrate capability and maintain system.

Deliverable

SOO

Task 4.2

Contractor’s PSM Report; Issue

Summary Report

COR

NLT 45

calendar days after Option

Period 1 award

NLT 10th day of each month of performance

At a minimum, shall address Man-Hours

Required, Funds Expended, Work

Completed, Program Cost Curves, Program

Risk Elements

Deliverable

SOO

Task 4.2

Annual In Process Review

COR

NLT 60

calendar days prior to end of

Option 1

Annually

Deliverable

SOO

Task 4.2

Meeting Minutes from Meetings with

Government

COR

NLT 30

calendar days after Option

Period 1 award

Minimum

Deliverable

SOO

Task 4.2

Provide Configuration and

Change Management Revision Control

Document.

COR

NLT 45

calendar days after Option

Period 1 award

Monthly Incorporate into

Monthly Progress Report

Distribute

To Initial Subsequent Comments

Deliverable

SOO

Task 4.2

Conduct IBR COR

NLT 30

calendar days after contract award

N/A

Includes performance specifications, integrated master schedule, quality assurance plan and statement of work

(SOW). From now on all of these deliverables shall be called Program

Documentation.

Deliverable

SOO

Task 4.2.1

Provide technical support for

Airworthiness Certification.

COR

Within 30 calendar days of Option Period 1 award

As required

Provide documents to support the product’s readiness to support

Airworthiness testing.

Deliverable

SOO

Task 4.2.1

Provide technical support for Joint Interoperability

Certification (JTIC) and Authority to Operate (ATO).

COR

Within 30 calendar days of Option Period 1 award

As required

ATO completed through the DoD Risk

Management Framework process.

Provide technical documents showing the product’s readiness complete RMF, including penetration testing and STIG checklist compliance

Deliverable

SOO

Task 4.2.1

Provide technical support and documentation before or during user testing.

COR

Within 45 calendar days of Option Period 1 award

As required

Provide testing documentation demonstrating the product’s readiness to perform successfully during a user assessment

Deliverable

SOO

Task 4.3

Contractor’s PSM Report; Issue

Summary Report

COR

NLT 45

calendar days after Option

Period 2 award

NLT 10th day of each month of performance

At a minimum, shall address (Man-Hours

Required, Funds Expended, Work

Completed, Program Cost Curves, Program

Risk Elements)

Deliverable

SOO

Task 4.3

Annual In Process Review

COR

NLT 60

calendar days prior to end of Option Period

Annually

Distribute

To Initial Subsequent Comments

Deliverable

SOO

Task 4.3

Meeting Minutes from Meetings with

Government

COR

NLT 30

calendar days after Option

Period 2

Minimum

Deliverable

SOO

Task 4.3

Configuration and Change Management

Revision Control Document.

COR

NLT 45

calendar days after Option

Period 2 award

Monthly Incorporate into

Monthly Progress Report

Deliverable

SOO

Task 4.3

Conduct IBR COR

NLT 30

calendar days after contract award

N/A

Includes performance specifications, integrated master schedule, quality assurance plan and statement of work

(SOW). From now on all of these deliverables shall be called Program

Documentation.

Deliverable

SOO

Task 4.3.1

Register device with FDA as a Class I product

FDA and

COR

NLT 60

calendar days after Option

Period 2 award

N/A

Deliverable

SOO

Task 4.4

Contractor’s PSM Report; Issue

Summary Report

COR

NLT 45

calendar days after Option

Period 3 award

NLT 10th day of each month of performance

At a minimum, shall address Man-Hours

Required, Funds Expended, Work

Completed, Program Cost Curves, Program

Risk Elements

Deliverable

SOO

Task 4.4

Annual In Process Review (IPR)

COR

NLT 60

calendar days prior to end of Option Period

Annually

Deliverable

SOO

Task 4.4

Meeting Minutes from Meetings with

Government

COR

NLT 30

calendar days after Option

Period 3

Minimum monthly

Distribute

To Initial Subsequent Comments

Deliverable

SOO

Task 4.4

Conduct IBR COR

NLT 30

calendar days after contract award

N/A

Includes performance specifications, integrated master schedule, quality assurance plan and statement of work

(SOW). From now on all of these deliverables shall be called Program

Documentation.

Deliverable

SOO

Task 4.4

Configuration and Change Management

Revision Control Document.

COR

NLT 45

calendar days after Option

Period 3 award

Monthly Incorporate into

Monthly Progress Report

Deliverable

SOO

Task 4.4.1

Manufacture and deliver 33 systems -

Low Rate Initial Production (LRIP)

COR

Within six (6) months of award of

Option Period

N/A

Deliverable

SOO

Task 4.4.1

Provide New Equipment Training

(NET) for the product

COR

14 calendar days prior to first LRIP quantity delivery

N/A

Deliverable

SOO

Task 4.4.1

Provide a Bill of Materials (BOM)

COR

14 calendar days prior to first LRIP quantity delivery

N/A

Deliverable

SOO

Task 4.4.1

Provide repair parts list with associated part number

COR

14 calendar days prior to first LRIP quantity delivery

N/A

Deliverable

SOO

Task 4.4.1

Provide list of required Test, Measurement, & Diagnostic

Equipment (TMDE)

COR

14 calendar days prior to first LRIP quantity delivery

N/A

Deliverable

SOO

Task 4.4.1

Provide Updated User Manuals, Maintenance

Manuals, and Quick Set-up Guides

COR

14 calendar days prior to first LRIP quantity delivery

N/A

Distribute

To Initial Subsequent Comments

Deliverable

SOO

Task 4.4.1

Provide technical maintenance manual with maintenance plan and maintenance schedule

COR

14 calendar days prior to first LRIP quantity delivery

N/A

Table 1. Deliverables

3.0 Deliverable Descriptions

Deliverable 1: Contractor’s PSM Report; Issue Summary Report The Contractor’s Progress, Status & Management Report shall indicate the work progress, man hours required, funds expended, and program status. The report shall include configuration and change management revision, control documentation for hardware and software, major accomplishments, work to be accomplished in the next month, performance, schedule, and cost updates. It shall also rate and document risks, risk mitigation activities, and issues raised by the Integrated Product Team. Contractor format is acceptable. The report is due the 10th working day of each month after award until contract conclusion.

Government will review submissions for compliance with the Statement of Work and other contract provisions.

Contractor has 10 working days to respond and resubmit upon receipt of Government final comments and shall provide the final document within 10 working days after approval of changes is received.

Deliverable 2: Annual In Process Review Annual In Process Reviews shall be conducted to review the current status of the technical performance of the contract. The first review shall occur no later than 60 calendar days prior to end of Base Period and annually after the first review.

Deliverable 3: Meeting Minutes from Meetings with Government The Meetings and meeting minutes with Government shall occur to communicate progress on tasks (as defined in the SOO and SOW); risks to cost, schedule, and performance; review PSM Report and other deliverables; and updates on any other on-going efforts. Meetings with Government can also be used as planning meetings to finalize dates for events such as IPRs, Annual In Process Reviews, and CDR. Meetings with Government can be cancelled at the discretion of the Government. The first meeting shall occur NLT 30 calendar days after contract award and reoccur at a minimum of twice a month.

Deliverable 4: Provide Configuration and Change Management Revision Control Document.

Configuration and Change Management Revision Control Document shall accurately reflect any and all changes that are made to the device throughout its lifecycle. This includes, but is not limited to, its technical capabilities, the ICD, system architecture, technical drawings, and any associated documentation. The Configuration and Change Management Revision Control Document shall act as a living document that represents the history of changes to the device. The date of change, reason for change, and implementation plan shall be part of the document. The document shall be provided monthly, as part of the Monthly Progress Report, and the first document shall be provided NLT 45 calendar days after contract award.

Deliverable 5: Provide Quality Assurance Plan Quality Assurance Plan shall be provided to ensure a consistent, high-quality, reliable device is produced as a result of the research, development, testing, evaluation, and manufacturing processes. The Quality Assurance Plan shall be provided at the IBR. The Government highly recommends providing a draft version of the Quality Assurance Plan prior to the delivery of the final version.

Deliverable 6: Conduct IBR IBR shall be conducted to ensure that the program’s efforts are consistently aligned with the SOO, SOW, Quality Assurance Plan, and expectations of the Government. The IBR shall focus on the product planning from a cost, schedule, and performance perspective. The IBR shall be conducted NLT 30 calendar days after contract award. The Government highly recommends providing a draft version of the IBR information prior to the delivery of the final version.

Deliverable 7: Design, build, and deliver four (4) prototypes of TRL of 5 Four prototypes and all the necessary components and equipment required to demonstrate capability and maintain the system shall be provided. The prototypes shall be functional and require minimal training to function. Prototypes shall work outside of the Contractor’s laboratory environment. The prototypes and necessary components shall be provided NLT six (6) months after contract award.

Deliverable 8: Provide an initial CDR PMDF CDR Master Data File shall contain, but is not limited to, all the technical data and information related to the system design, architecture, technology selection criteria assessments, and performance specifications. The File shall also include of all documentation necessary for the development, manufacturing, and support of the automated IV Pressure Infuser. The File shall be provided to the Government at least seven (7) calendar days prior to CDR execution (Deliverable 11) on blue-ray DVD and downloadable from a Government file share site. The Government highly recommends providing a draft version of the CDR PMDF prior to the delivery of the final version.

Deliverable 9: Conduct CDR Event & Report The CDR shall be a technical review assessing the proposed final system design, including its final configuration, architecture, technology selection criteria assessments, and performance specifications. The CDR shall encompass both past and future efforts. The CDR and delivery of the CDR report shall occur NLT 14 months after contract award. The CDR report shall summarize the CDR event. The Government highly recommends proving a draft version of the CDR and the CDR report prior to the delivery of the final version to include action items from the CDR event.

Deliverable 10: Submit final CDR PMDF The CDR PMDF shall be provided fourteen (14) calendar days after the CDR event. The PMDF shall include the system design, architecture, technology selection criteria assessments, a level of repair analysis, and performance specifications.

Deliverable 11: Design, build, and deliver six (6) prototypes of post-CDR systems Six (6) post-CDR prototypes shall be delivered, with all the accessories and components required to demonstrate capability and maintain the system. Prototypes shall be TRL 6 and be delivered at least seven (7) calendar days prior to the completion of Base Period.

Deliverable 12: Contractor’s PSM Report; Issue Summary Report See Deliverable 1.

Deliverable 13: Annual In Process Review See Deliverable 2.

Deliverable 14: Meeting Minutes from Meetings with Government See Deliverable 3.

Deliverable 15: Provide Configuration and Change Management Revision Control Document.

See Deliverable 4.

Deliverable 16: Conduct IBR See Deliverable 6.

Deliverable 17: Provide technical support for Airworthiness Certification Contractor shall provide all electrical, networking, and vibration testing that has been completed on the product within 30 calendar days of award of Option Period 1 to initiate Government Airworthiness Certification.

Deliverable 18: Provide technical support for JTIC and ATO Contractor shall provide Security Technical Implementation Guide (STIG) completion and penetration testing for the product to support Government network certifications within 30 calendar days of award of Option Period 1.

Deliverable 19: Provide technical support during user testing.

Contractor shall provide testing documentation demonstrating the product’s readiness to perform successfully during a user assessment within 45 calendar days of Option Period 1 award.

Deliverable 20: Contractor’s PSM Report; Issue Summary Report

See Deliverable 1.

Deliverable 21: Annual In Process Review See Deliverable 2.

Deliverable 22: Meeting Minutes from Meetings with Government See Deliverable 3.

Deliverable 23: Configuration and Change Management Revision Control Document.

See Deliverable 4.

Deliverable 24: Conduct IBR See Deliverable 6.

Deliverable 25: Register device with FDA as a Class I product Contractor shall submit the required documentation in accordance with the Statement of Objectives to the FDA NLT 60 days after Option Period 2 award. Contractor shall provide the Government copies of all FDA submissions and meeting minutes with the FDA generated by the Contractor prior to and during performance of contract necessary to pursue FDA filing as a Class I…