RFQ HT942524Q0007 USFP System.pdf

SEE ADDENDUM

(No Collect Calls)

HT942524Q0007 18-Oct-2023

b. TELEPHONE NUMBER

301-619-1342

8. OFFER DUE DATE/LOCAL TIME

12:00 PM 17 Nov 2023

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

HT94259. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

CHRISTOPHER SULT

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

0 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED ORX

SMALL BUSINESS

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

ARMY MED RES ACQ ACTIVITY

808 SCHREIDER ST

FORT DETRICK MD 21702

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE HT0986 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

ARMY MMDA - MM

USAMMDA

1430 VETERANS DRIVE

FORT DETRICK MD 21702-5009

TEL: FAX:

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

1,250

NAICS:

334510

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF50

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

HT942524Q0007

Section SF 1449 - CONTINUATION SHEET

MINIMAL ESSENTIAL CHAR (MEC)

MINIMAL ESSENTIAL CHARACTERISTICS (MEC)

1. SYSTEM DESCRIPTION

The Ultrasound Field Portable (USFP) system shall be handheld, easily transportable (including transducer(s) and viewing platform), reliable, have minimal power requirements, with all required accessories. The USFP system should have the ability to remove network connectivity (i.e. ability to function and perform software updates without connectivity to any network and cloud domain). The Government’s intent is that the handheld portable USFP system should meet field environmental and operational testing conditions. The USFP system shall provide imaging quality sufficient for diagnosis in the Focused Assessment with Sonography in Trauma (FAST), Extended FAST (eFAST) and Musculoskeletal Injury (MSKI) exams. The USFP shall enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult patients.

2. MINIMAL ESSENTIAL CHARACTERISTICS

The following minimal essential characteristics shall be met for the device to be considered acceptable.

Number Essential Characteristic

(EC) Threshold (T) Objective (O) 1 U.S. FDA Clearance Shall have U.S. FDA Clearance T=O 2 Focused Assessment with

Sonography for Trauma (FAST) Capable

Shall be FDA-Cleared for use in the abdomen and capable of performing FAST exams.

T=O

3 Extended Focused Assessment with Sonography for Trauma (e- FAST) Capable

Shall be FDA Cleared for us e in the abdomen and for cardiac use, and capable of performing eFAST exams

T=O

4 Musculoskeletal (MSK) Capable

Shall be FDA Cleared for musculoskeletal use and capable of performing MSK/MSKI exams

T=O

3. ADDITIONAL PERFORMANCE CHARACTERISTICS

The following additional performance characteristics are desired, but not essential for the device to be considered acceptable.

Number Additional Performance

Characteristics Threshold (T) Objective (O) 1 Power Source Duration The power source should last for two hours at the highest setting

The power source should last for five hours or more at the highest setting

2 Power Source The power source should be rechargeable

The power source should be rechargeable and interchangeable

3 Weight The complete USFP system (screen & transducer(s)) should not weight more than three pounds

The complete USFP system (screen & transducer(s)) should not weight more than 0.5 pounds

4 Size The complete USFP system (screen & transducer(s))

The complete USFP system (screen & transducer(s)) should should be a cube of no more than 280 cubic inches be a cube of no more than 160 cubic inches

5 High Temperature The fully functional USFP system should be operational at all settings at 49°C

The fully functional USFP system should be operational at all settings at 60°C

6 Low Temperature The fully functional USFP system should be operational at all settings at -1°C

The fully functional USFP system should be operational at all settings at -26°C

7 Transducer(s) The USFP system should have transducers to perform FAST, eFAST and MSK exams

The USFP system should have one transducer to perform FAST, eFAST and MSK exams (can have multiple heads on transducer)

8 Storage The USFP system should have at least 8 GB of storage space

The USFP system should have at least 16 GB of storage space

9 Network Connectivity The network connection capabilities can be turned off from all components of the USFP system

The USFP system does not connect to any networks

10 Software Updates If software updates are required on any component in the USFP system, the frequency of updates can be adjusted

If software updates are required on any component in the USFP system, the frequency of updates can be adjusted out to 18 months or longer

STATEMENT OF NEED (SON)

STATEMENT OF NEED (SON)

Original Date: 20 September 2023

Revised Date: 18 October 2023

Title: ULTRASOUND FIELD PORTABLE (USFP) PROCUREMENT FOR TESTING

Requiring Activity/Agency Name: The U.S. Army Medical Materiel Development Activity (USAMMDA) / Warfighter Expeditionary Medicine and Treatment Project Management Office (WEMT PMO), Fort Detrick, MD

Program Name: Ultrasound Field Portable (USFP)

1. PURPOSE

The mission of the U.S. Army Medical Research and Development Command (USAMRDC) is to “Responsively and responsibly create, develop, deliver, and sustain medical capabilities for the Warfighter.”

Accordingly, it is the mission of the U.S. Army Medical Materiel Development Activity (USAMMDA) Warfighter Expeditionary Medicine and Treatment Project Management Office (WEMT PMO) to acquire Ultrasound Field Portable (USFP) systems.

The U.S. Army has a requirement to fill the gap in combat injury by acquiring and field testing USFP systems in accordance with the Department of Defense (DoD) Acquisition System, Food and Drug Administration (FDA) regulations and guidelines, and industry best practices.

The requirement under this Statement of Need (SON) is intended to result in multiple awards for a commercial USFP system (including transducer(s) and viewing platform) that is handheld, reliable, easily transportable, and meets the Minimal Essential Characteristic threshold with all required accessories.

2. HISTORY

Inappropriate identification, care, and triage are responsible for the more than 10% of unintended outcomes following combat injury. According to the Theater Combat Casualty Care Initial Capabilities Document (ICD) there are several issues where gaps exist, including the ability to detect/diagnose injury in an austere and/or pre-hospital environment. The DoD expects a future operational environment that will require prolonged field care, delayed or denied evacuation, and increased capabilities further forward than in recent conflicts. Currently, no portable ultrasound imaging capability is fielded to the Role 1 through a medical equipment set.

The current handheld ultrasound market technology consists of a transducer (or transducers) that connects to a viewing platform, paired with the software application. The commercial product is developed with the civilian provider in mind, and the products have connectivity features, both for the software application and for the viewing platform, that pose a cybersecurity threat in a military operational environment. The commercial systems on the market require additional assessments to ensure they are operable under expected conditions.

3. SCOPE OF WORK

The Government intends to award multiple contracts for the procurement of ultrasound systems for operational and environmental testing, along with having Contractor personnel travel to the operational test to perform a “show and tell” of the ultrasound system. The ultrasound systems shall meet the required Minimum Essential Characteristics and should meet the desired Additional Performance Characteristics.

3.1 PARTS AND ACCESSORIES

3.1.1 The Contractor shall provide nine (9) USFP systems, containing all components listed in 3.1.2 and 3.1.3.

3.1.2 The Contractor shall include all accessories necessary for the function, service, and maintenance of the USFP system, to include:

Hand-Held Ultrasound Transducer(s) Small Viewing Platform with Applicable Software/Application, capable of turning off the ability to connect to any networks The Software/Application must be ready to go so that the USFP can be used upon delivery

Battery(ies) and/or Charging Accessories for both the Transducer(s) and Viewing Platform User/Operator manuals and service manuals All Accessories needed to fully operate the system A Ruggedized/Hardened Case to contain the system and all components

3.1.3 The Contractor shall consolidate and package the complete USFP system, including all items listed in 3.1.2, in a ruggedized/hardened case. The ruggedized/hardened case for the system shall provide protection to the system from harsh environments. The case may be validated with MIL-STD-810H testing.

3.2 DEVICE TESTING

3.2.1 The Contractor shall perform a “show and tell” presentation for test users, demonstrating how the ultrasound system works, addressing overall general system performance/function and maintenance.

3.2.1.1 Up to two (2) Contractor personnel shall travel to a site within the Continental United States for two (2) days for a Government-led Operational Test. The operational test will be conducted to ensure the ultrasound system provides imaging quality sufficient for diagnosis in the Focused Assessment with Sonography in Trauma (FAST), Extended FAST (eFAST) and Musculoskeletal Injury (MSKI) exams.

3.2.1.2 Prior to the “show and tell” presentation, Contractor personnel shall have prepared the ultrasound system so that it is ready to be demonstrated without the need for set up.

3.2.1.3 During the “show and tell” presentation, Contractor personnel shall demonstrate the operational functions of all of the ultrasound system components, shall demonstrate using the ultrasound system to perform the FAST, eFAST and MSKI exams, and shall address all questions from the end users.

3.2.1.4 The Contractor shall bring the equipment necessary for demonstrating the ultrasound system (i.e. ultrasound system components including the viewing screen that is part of the ultrasound system, and whatever equipment needed to launch a presentation) and shall work with the Government team on any audio-visual support equipment that will be needed for the demonstration (i.e. projection equipment, microphone, etc.).

3.2.2 The Government will also conduct environmental testing to MIL-STD-810. This testing does not require involvement from the Contractor.

3.3 WARRANTY AND MAINTENANCE

3.3.1 Supportability Design. The Contractor shall provide a supportability design discussion addressing the proposed solution’s approach and incorporates ease of use, innovation, and flexibility.

3.3.2 The Contractor shall provide all maintenance and sustainment information for the proposed solution addressing reliability and maintainability metrics, e.g. Mean Time Between Failure and Mean Time Between Failure data.

3.3.3 The Contractor shall provide a description of the most common failure modes, and the root cause and consequence of each, for the proposed solution. Also provide a description of those failure modes that are in frequent but have severe negative consequence for the proposed solution. The description of consequences shall include a discussion of the known downtime costs that are typically experienced for each failure mode.

3.3.4 The Contractor shall provide the key operating and maintenance practices required to mitigate and minimize these failure modes.

3.3.5 The Contractor shall provide a completed Medical Device Evaluation and Risk Assessment (MDERA) form (Attachment 1).

3.4 ANTI-TERRORISM/OPERATIONS SECURITY

3.4.1 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 (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

3.4.2 For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations. Contractor personnel must be escorted by a U.S. Service Member or DA Civilian employee at all times they are inside a U.S. government facility or in possession of used U.S. government information storage devices.

3.4.3 iWATCH Training. The contractor and all associated sub-contractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This local developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and reported to the COR within 7 calendar days of new employee's commencing performance on an active contract.

4. POTENTIAL FUTURE FOLLOW-ON CONTRACTS

The government will conduct Operational and Environmental testing. The purpose of this analysis is to evaluate each candidate device’s ability to function successfully in an austere environment, the ability of the Army to sustain the device for the anticipated life of the device, and validate the device meets or exceeds the minimum essential characteristics. The Government intends to award a single follow-on award for a Risk Management Framework (RMF) assessment and potential modifications to meet the RMF standards. After the completion of the RMF assessment award, the Government intends to award a follow-on award for procurement. The procurement will be for an estimated three thousand five hundred (3,500) USFP systems over a five (5) year period.

5. DELIVERY DATES AND LOCATIONS

5.1 DELIVERY DATES

5.1.1 The Contractor should deliver complete USFP systems within fifteen (30) calendar days of award.

5.1.2 The Contractor shall perform a “show and tell” presentation for test users. The dates are estimated to be in March 2024. Exact dates of the testing event and “show and tell” presentation will be provided by the Government after contract award.

5.2 LOCATIONS

5.2.1 Delivery of USFP Systems

Deliveries shall be Free on Board (FOB) destination, to:

ATTN: TBD

U.S. Army Medical Materiel Development Activity (USAMMDA) 1430 Veterans Drive Fort Detrick, MD 21702-5009

5.2.2 Place of Operational Testing

Joint Base San Antonio Fort Sam Houston, San Antonio, TX

*Note: This exact location is subject to change, but the testing will take place in the Continental United States

6. INSPECTION AND ACCEPTANCE

Certification by the Government of satisfactory goods or services provided is contingent upon the Contractor performing in accordance with the terms and conditions of any resultant contract. Items determined to not be in accordance with the terms of the contract upon receipt inspection will be returned to the Contractor.

7. ATTACHMENTS

7.1. Attachment 1 – Medical Device Evaluation and Risk Assessment (MDERA) form

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 9 Each USFP System

FFP

Ultrasound Field Portable (USFP) System in accordance with (IAW) the Statement of Need (SON) and Minimal Essential Characteristics (MEC).

FOB: Destination

PSC CD: 6525

NET AMT

0002 9 Each Shipping

FFP

Shipping of the Ultrasound Field Portable (USFP) System in accordance with (IAW) the Statement of Need (SON)

0003 1 Each Show and Tell Presentation

FFP

Show and Tell Presentation for the Ultrasound Field Portable (USFP) System in accordance with (IAW) the Statement of Need (SON)

0004 Job Travel

COST

Travel for the Show and Tell Presentation for the USFP System in accordance with (IAW) the Statement of Need (SON)

ESTIMATED COST

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

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 08-JAN-2024 9 ARMY MMDA - MM

USAMMDA

1430 VETERANS DRIVE

FORT DETRICK MD 21702-5009

HT0986

0002 08-JAN-2024 9 (SAME AS PREVIOUS LOCATION)

0003 04-MAR-2024 1 (SAME AS PREVIOUS LOCATION)

0004 04-MAR-2024 1 (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.204-7 System for Award Management OCT 2018 52.204-13 System for Award Management Maintenance OCT 2018 52.204-16 Commercial and Government Entity Code Reporting AUG 2020 52.204-18 Commercial and Government Entity Code Maintenance AUG 2020 52.204-21 Basic Safeguarding of Covered Contractor Information

Systems

NOV 2021

52.212-4 Contract Terms and Conditions--Commercial Products and Commercial Services

DEC 2022

52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran-- Representation and Certifications.

JUN 2020

52.232-40 Providing Accelerated Payments to Small Business Subcontractors

MAR 2023

252.203-7005 Representation Relating to Compensation of Former DoD Officials

SEP 2022

252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support

JAN 2023

252.204-7017 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services -- Representation

MAY 2021

252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services

JAN 2023

252.223-7008 Prohibition of Hexavalent Chromium JAN 2023 252.225-7001 Buy American And Balance Of Payments Program--Basic JAN 2023 252.225-7002 Qualifying Country Sources As Subcontractors MAR 2022 252.225-7055 Representation Regarding Business Operations with the

Maduro Regime

MAY 2022

252.225-7056 Prohibition Regarding Business Operations with the Maduro Regime

JAN 2023

252.232-7003 Electronic Submission of Payment Requests and Receiving Reports

DEC 2018

252.232-7010 Levies on Contract Payments DEC 2006

252.244-7000 Subcontracts for Commercial Products or Commercial Services

JAN 2023

252.247-7023 Transportation of Supplies by Sea JAN 2023

CLAUSES INCORPORATED BY FULL TEXT

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services-- Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications- Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services."

(d) Representations. The Offeror represents that--

(1) It [ ___ ] will, [ ___ ] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that--

It [ ___ ] does, [ ___ ] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of provision)

52.209-12 CERTIFICATION REGARDING TAX MATTERS (OCT 2020)

(a) This provision implements section 523 of Division B of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235), and similar provisions, if contained in subsequent appropriations acts.

(b) If the Offeror is proposing a total contract price that will exceed $5.5 million (including options), the Offeror shall certify that, to the best of its knowledge and belief, it--

(1) Has [ ] filed all Federal tax returns required during the three years preceding the certification;

(2) Has not [ ] been convicted of a criminal offense under the Internal Revenue Code of 1986; and

(3) Has not [ ], more than 90 days prior to certification, been notified of any unpaid Federal tax assessment for which the liability remains unsatisfied, unless the assessment is the subject of an installment agreement or offer in compromise that has been approved by the Internal Revenue Service and is not in default, or the assessment is the subject of a non-frivolous administrative or judicial proceeding.

52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

(SEP 2023)

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code(s) and small business size standard(s) for this acquisition appear elsewhere in the solicitation. However, the small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees, or 150 employees for information technology value-added resellers under NAICS code 541519, if the acquisition--

(1) Is set aside for small business and has a value above the simplified acquisition threshold;

(2) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(3) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(b) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show--

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of offers;

(3) The name, address, and telephone number of the offeror;

(4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

(8) A completed copy of the representations and certifications at Federal Acquisition Regulation (FAR) 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);

(9) Acknowledgment of Solicitation Amendments;

(10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and

(11) If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of offers. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender's request and expense, unless they are destroyed during preaward testing.

(e) Multiple offers. Offerors are encouraged to submit multiple offers presenting alternative terms and conditions, including alternative line items (provided that the alternative line items are consistent with FAR subpart 4.10), or alternative commercial products or commercial services for satisfying the requirements of this solicitation. Each offer submitted will be evaluated separately.

(f) Late submissions, modifications, revisions, and withdrawals of offers:

(1) Offerors are responsible for submitting offers, and any modifications, revisions, or withdrawals, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that offers or revisions are due.

(2)(i) Any offer, modification, revision, or withdrawal of an offer received at the Government office designated in the solicitation after the exact time specified for receipt of offers is “late” and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition; and--

(A) If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of offers; or

(B) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or

(C) If this solicitation is a request for proposals, it was the only proposal received.

(ii) However, a late modification of an otherwise successful offer, that makes its terms more favorable to the Government, will be considered at any time it is received and may be accepted.

(3) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the offer wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel.

(4) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(5) Offers may be withdrawn by written notice received at any time before the exact time set for receipt of offers.

Oral offers in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile offers, offers may be withdrawn via facsimile received at any time before the exact time set for receipt of offers, subject to the conditions specified in the solicitation concerning facsimile offers. An offer may be withdrawn in person by an offeror or its authorized representative if, before the exact time set for receipt of offers, the identity of the person requesting withdrawal is established and the person signs a receipt for the offer.

(g) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with offerors. Therefore, the offeror's initial offer should contain the offeror's best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest; accept other than the lowest offer; and waive informalities and minor irregularities in offers received.

(h) Multiple awards. The Government may accept any item or group of items of an offer, unless the offeror qualifies the offer by specific limitations. Unless otherwise provided in the Schedule, offers may not be submitted for quantities less than those specified. The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit prices offered, unless the offeror specifies otherwise in the offer.

(i) Availability of requirements documents cited in the solicitation.

(1)(i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of Federal specifications, standards, and product descriptions can be downloaded from the ASSIST website at https://assist.dla.mil.

(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained from the address in paragraph (i)(1)(i) of this provision.

(2) Most unclassified Defense specifications and standards may be downloaded from the ASSIST website at https://assist.dla.mil.

(3) Defense documents not available from the ASSIST website may be requested from the Defense Standardization Program Office by--

(i) Using the ASSIST feedback module (https://assist.dla.mil/feedback); or

(ii) Contacting the Defense Standardization Program Office by telephone at 571-767-6688 or email at assisthelp@dla.mil.

(4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance.

(j) Unique entity identifier. (Applies to all offers that exceed the micro-purchase threshold, and offers at or below the micro-purchase threshold if the solicitation requires the Contractor to be registered in the System for Award Management (SAM).) The Offeror shall enter, in the block with its name and address on the cover page of its offer, the annotation "Unique Entity Identifier" followed by the unique entity identifier that identifies the Offeror's name and address. The Offeror also shall enter its Electronic Funds Transfer (EFT) indicator, if applicable. The EFT indicator is a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the Offeror to establish additional SAM records for identifying alternative EFT accounts (see FAR subpart 32.11) for the same entity. If the Offeror does not have a unique entity identifier, it should contact the entity designated at www.sam.gov for unique entity identifier establishment directly to obtain one. The Offeror should indicate that it is an offeror for a Government contract when contacting the entity designated at www.sam.gov for establishing the unique entity identifier.

(k) Reserved.

(l) Debriefing. If a post-award debriefing is given to requesting offerors, the Government shall disclose the following information, if applicable:

(1) The agency's evaluation of the significant weak or deficient factors in the debriefed offeror's offer.

(2) The overall evaluated cost or price and technical rating of the successful and the debriefed offeror and past performance information on the debriefed offeror.

(3) The overall ranking of all offerors, when any ranking was developed by the agency during source selection.

(4) A summary of the rationale for award;

(5) For acquisitions of commercial products, the make and model of the product to be delivered by the successful offeror.

(6) Reasonable responses to relevant questions posed by the debriefed offeror as to whether source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities were followed by the agency.

ADDENDUM TO: 52.212-1 - ADDITIONAL INSTRUCTIONS

(a) Instructions To Offerors. The Offerors response to this RFQ shall be legible and comprehensive to enable the Government to conduct the technical evaluation of the Offeror’s ability to meet the Statement of Need (SON) and Minimal Essential Characteristics (MEC) identified within this Requst for Quote (RFQ). The information shall be precise, factual, and complete. Failure to submit all information concurrently and in accordance with these instructions shall render the Offeror’s quote “unacceptable”.

(b) General Information. Offerors shall provide all information required to ensure quotes are technically acceptable in accordance with the RFQ and the evaluation criteria. Offerors shall submit the information necessary to convey technical acceptability, sustainment and maintainability, and price in accordance with the RFQ. Offerors should fully document and substantiate a cross mapping of their price approach as it equates to the Technical Capability listed in the evaluation criteria. Offerors should provide the necessary information to support the price proposed.

(b) Technical Information. Offerors shall ensure to specify the required products/equipment necessary to support the RFQ. Offerors should provide all necessary Technical Capabilities/Specifications/Salient Characteristics necessary to cross map to the SON and MEC easily indicating the Offeror can provide the requested configuration with the requested technical capabilities/specifications and maintenance support described in the RFQ and can meet the delivery schedule. The Offeror should clearly list out if they meet or do not meet requirements listed in the SON and MEC, explain how they meet or do not meet each requirement including appropriate references (for example;

see page 3 of warranty, see page 6 of service manual, see attached certification, etc.). Lack of a response to a MEC may be assumed to have not met that requirement.

(c) Device Testing. Show and Tell Presentation. The quote should demonstrate that the Offeror can perform a Show and Tell presentation for test users, demonstrating how the ultrasound system works, adressing overall general system performance/function and maintenance.

(d) Warranty And Maintenance. The quote shall the required information outlined in the SON to include supportability design discussion, maintenance and sustainment information, key operating and maintenance, and a completed Medical Device Evaluation and Risk Assessment form (Attachment - 1).

(e) Price Quote Instructions. The Offeror shall provide a total price for each Contract Line Item Number (CLIN) identified in this RFQ under Supplies/Services. The Government anticipates award of a Firm-Fixed Price (FFP) contract and the Offeror shall propose a FFP pricing on CLINs 0001 – 0003 and a Cost for CLIN 0004 (Travel) either by cost/price or “NSP” (Not Separately Priced). A line item price left blank will be considered incomplete and may not be considered for award.

(f) Offerors responding to this RFQ shall complete the following Provisions /Clauses:

52.212-3 Offeror Representations and Certifications-Commercial Items

(g) Other Administrative Instructions: System for Award Management (SAM). Contractors must be registered in SAM to be considered for award. Registration is free and can be completed on-line at http://www.sam.gov; provide SAM Unique Entity number; Cage Code and TIN.

** Please Note that the DUNS Number will no longer be used as part of Contractor Identification after 1 April 2022.

You will need to have your SAM Unique Entity number and CAGE Code.

(h) RFQ Questions: Questions to this RFQ are due via e-mail no later than 26 October 2023 at 4:00 PM EST to Christopher Sult, Contract Specialist, at christopher.m.sult.civ@health.mil.

(i) RFQ Due Date: Response to this RFQ are due via e-mail no later than 17 November 2023, at 12:00 PM EST via e-mail to Christopher Sult, Contract Specialist, at chrisotpher.m.sult.civ@health.mil.

52.212-2 EVALUATION--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Factor 1 – Technical Capability Factor 2 – Price

Award of this contract shall be made on a competitive best value basis, using “best value tradeoff” among price and non-price factors. A best value tradeoff process will be used, thus the Government may award to other than the lowest priced Offeror, or other than the Offeror with the highest rated non-cost proposal. Award will be made based on the overall “Best Value” quote that is determined to be most beneficial to the Government, with appropriate consideration given to the evaluation factors Technical Capability and Price.

Technical Capability is more important than Price.

(b) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

(a) Definitions. As used in this provision --

"Covered telecommunications equipment or services" has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

"Economically disadvantaged women-owned small business (EDWOSB) concern" means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127, and the concern is certified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

"Forced or indentured child labor" means all work or service-

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

"Highest-level owner" means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

"Immediate owner" means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

"Inverted domestic corporation" means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

"Manufactured end product" means any end product in product and service codes (PSCs) 1000-9999, except--

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC…