RFQ-HT942523R0053.pdf

SEE ADDENDUM

(No Collect Calls)

HT942523R0053 24-Mar-2023

b. TELEPHONE NUMBER

301-619-7414

8. OFFER DUE DATE/LOCAL TIME

12:00 PM 10 Apr 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

MATTHEW D. TEEL

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:

1,000

NAICS:

339112

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 OF62

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.

HT942523R0053

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 2 Each Ultrasonic Blood Flow Test Article

FFP

Ultrasonic Blood Flow Test Article In accordance with (IAW) the Statement of Need (SON), Minimal Essential Characteristic (MEC), and Request for Quotation

(RFQ).

FOB: Destination

PSC CD: 6515

NET AMT

0002 1 Each Ultrasonic Blood Flow Training

FFP

Ultrasonic Blood Flow Training IAW the SON, MECs, and RFQ.

0003 2 Each Ultrasonic Blood Flow Warranty

FFP

Basic Warranty for Ultrasonic Blood Flow Training IAW the SON, MECs, and

RFQ.

0004 2 Each Ultrasonic Blood Flow Maintenance Plan

FFP

Maintenance Plan for Ultrasonic Blood Flow Training IAW the SON, MECs, and

RFQ.

0005 2 Each OPTION OPTION: Extended Warranty

FFP

OPTIONAL Extended Warranty for Ultrasonic Blood Flow Training IAW the SON, MECs, and RFQ.

STATEMENT OF NEED & MECS

STATEMENT OF NEED

Original Date: 22 July 2022 Revised Date: 27 February 2023

Title: ULTRASONIC UNIT, BLOOD FLOW DETECTION

Requiring Activity/Agency Name: U.S. Army Medical Material Development Activity (USAMMDA)/Medical Modernization, Warfighter Deployed Medical Systems PMO

Program Name: Medical Modernization, Warfighter Deployed Medical Systems PMO

Requirements notated by “(***)” following the paragraph number shall be confirmed by the Offeror. These requirements will either be provided upon award of any resulting contract/order or will be required for any follow-on actions. Failure to provide confirmation on items notated with “(***)” may be considered not meeting that section of the Statement of Need (SON).

The Government may award one or more additional follow-on contracts, on a sole-source basis, to the

Offeror(s) providing the best overall value to the Government resulting from successful first article testing. Follow-on procurements are estimated to require a minimum purchase of ten (10), up to an estimated 450 products over a five-year period of performance. ***

1. PURPOSE

The USAMMDA, Medical Modernization, Warfighter Deployed Medical Systems (WDMS) Project Management Office (PMO) requires an Ultrasonic Unit, Blood Flow Detection for use in a deployed medical setting (Role of Care 3). The Ultrasonic Unit, Blood Flow Detection is used to assess blood flow in an artery prior to, during, or after surgery through the use of sound waves.

USAMMDA expects to award multiple contracts (to no more than 3 Offerors) for the procurement of the Ultrasonic Unit, Blood Flow Detection, with all its components and accessories, packaged and packed securely in one self-contained hardened case with closed-cell foam. Up to three (3) Offerors best meeting the requirements outlined in this Request for Quote (RFQ) will be selected to participate for First Article Testing (FAT). FAT will be performed to evaluate the device’s performance against the minimum essential characteristics (MEC), and maintenance and sustainment for use in an austere environment including evaluation of training and ability for Army personnel to calibrate and repair the device in the field. The Government reserves the right to waive any part of FAT including the requirement of an Authorization to Operate (ATO).

2. HISTORY

A replacement product is required for the currently fielded Ultrasonic Unit, Blood Flow Detection device to maintain Army readiness and the ability of medical treatment facilities (MTF) in the field to assess blood flow in an artery prior to, during, or after surgery. Transcutaneous blood flow assessments are critical to identifying arterial injuries. A critical step in repairing arterial injuries is to use Doppler directly on the repaired vessel to demonstrate restored flow prior to concluding surgery. In the early post-operative period, limb perfusion is monitored using transcutaneous Doppler to ensure restoration of flow and identification of changes in perfusion. Proper perioperative and intraoperative limb perfusion assessment is necessary for combat surgery. Delays in intervention may lead to loss of limb function up to and including amputation.

The intent is for the vendor to provide an Ultrasonic Unit, Blood Flow Detection system that is straightforward to use. The user (e.g., surgeon) shall be able to easily instruct others (e.g., nurse) to make the necessary adjustments on the device if needed during a procedure.

Biomedical Equipment Specialists (BMETs) are the maintainers for this system who provide preventative maintenance in regular intervals as set forth by the Original Equipment Manufacturer (OEM); normally a minimum of annually or biannually. If preventative maintenance is not completed, the equipment in the field is not considered mission capable. Any equipment that is needed to calibrate, fix, or perform preventative maintenance on the Ultrasonic Unit, Blood Flow Detection shall be clearly identified with the name, part number, reason (why is it needed), country of origin, and if it is commercially available or proprietary to the manufacturer.

3. SCOPE OF WORK

3.1 PARTS AND ACCESSORIES SUPPORT

3.1.1 The vendor shall provide a configuration that includes the Ultrasonic Unit, Blood Flow Detection with all accessories necessary for the function, service, calibration, and maintenance of the device for the first seventy-two hours of use (all tools and equipment necessary to maintenance in theatre without requiring a separate procurement), which shall include but is not limited to the following:

Ultrasonic Unit, Blood Flow Detection Ancillary items, as needed, such as probes (durable/reusable and disposable), probe adaptors, ultrasound gel, power cord, batteries, or any tools required for calibration or other routine maintenance Equipment set-up and re-packing instructions, with photos or diagrams User/Operator manuals and service manuals Reusable hard-side case to provide consolidation of items as well as protection during transport and storage Test, measurement, and diagnostic equipment (TMDE) needed for the maintenance and calibration of the device Training for up to four operator personnel Training for up to two maintenance personnel

The vendor shall create a standard configuration that can be ordered under a single part number. Part numbers shall be provided for each component with a SINGLE overarching part number for the government-configured set that is being proposed. For items that are non-Trade Agreements Act (TAA) compliant, the vendor must provide an acceptable TAA compliant substitution/addition request along with their quotationl.

upon shipment to the government, the above items shall be consolidated and packaged in the ruggedized case with a SINGLE part number for the configured set.

3.1.2 The contractor shall provide a hard-sided transport case that shall ensure the equipment can survive shock, introduced in drops or other jarring during shipping via ground, ship, or air transport.

3.1.3 The contractor shall agree to support all repair parts and accessories under this contract for the life of the contract.

3.1.4 Vendor shall identify all items considered to be high-failure repair parts to purchase as needed for repairs in the field by government-trained personnel along with any procedures, information, data, passwords, or calibration standards/standard operating procedures (SOPs) required. Vendor shall include all repair parts and consumables as separate items to be purchased from the Defense Logistics Agency (DLA) Electronic Catalog (ECAT) upon award of the contract. The vendor shall identify the point of contact at DLA, dates, and items submitted including part numbers and any issues to the Government upon request. ***

3.1.5 The Contractor shall provide a listing denoting the configuration of items required for each unit, repair parts, consumables, and replacement parts that shall include, but is not limited to the following:

A list of any required items, including part numbers, which are proprietary to the system needed for use, maintenance, calibration, repair and/or installation

A list of any required non-propriety items including part numbers needed for use, maintenance, calibration, and/or installation

Ordering information for replacement of consumables Cost for each part number and country of origin The weight and size of each item outside of the packaging with a picture The weight and size of the configuration outside the packaging with a picture The weight and size of the configuration in OEM packaging with shipping weight and size (e.g., the size and weight of the configuration in the hard case; the size and weight of the configuration in the hard case packaged as it will be shipped to the Government)

The weight and size of each item in OEM packaging with shipping weight and size

3.2 PACKAGING, STORAGE, AND TRANSPORTATION

3.2.1 Contractor shall have the complete Ultrasonic Unit, Blood Flow Detection, with all its components and accessories, packaged securely in a single self-contained hardened case with closed-cell foam (e.g., Hardigg, Pelican, ECS Case and/or equivalent). The case shall have the approved, marked data plates with the following information:

National Stock Number – Actual NSN(s) to be provided after award by the Government.

Nomenclature – Nomenclature to be provided after award by the Government.

Manufacturer Model Part Number

3.2.2 Each case/system shall include the pertinent Item Unique Identification (IUID) in accordance with clause DFARS 252.211-7003, Item Unique Identification and Valuation (DEC 2013).

3.2.3 The transport case for the system shall provide protection to the system from harsh environments.

Transport case may be validated with MIL-STD-810H testing to include but not limited to the following tests:

vibration, temperature, transport, and humidity.

3.2.4 Ultrasonic Unit, Blood Flow Detection devices and accessories shall be able to function with no degradation of performance up to original manufacturer specifications regarding: ***

Storage Temperature Range Operating Temperature Range

Storage Humidity Range

The contractor shall provide a listing of the original manufacturer specifications for the storage and use of the device that shall include, but is not limited to, operating and storage temperature ranges, operating and storage humidity ranges, lumens, power requirements (type, medical grade plug if applicable, maximum power draw), and any other parameters as noted by either the manufacturer and/or the minimum essential characteristics.

3.2.5 System shall be ready for operation when removed from the transport case (plug and play) within 30 minutes.

3.2.6 Vendor shall provide storage instructions for both short-term (less than 6 months) and long-term (greater than 6 months) storage to include required maintenance before returning to service.

3.3 WARRANTY AND MAINTENANCE

3.3.1 The vendor shall provide a maintenance plan that shall clearly outline what tasks can be performed by the system Operator and system Biomedical Equipment Specialist (BES) without voiding the warranty. The contractor shall clearly describe preventative maintenance tasks, expected time requirements to complete, and recommended intervals in the maintenance plan that includes, but is not limited, to the following:

The typical preventative maintenance required by time (e.g., it needs to be calibration annually; it needs to be cleaned after each use)

The typical calibration required by time List of preventative maintenance and repairs that can be completed in the field by Army personnel (note – if OEM training is required for each item) List of preventative maintenance and repairs that can only be completed by the OEM

3.3.2 Contractor shall provide a manufacturer warranty for at least one (1) year. This warranty shall include all Parts and OEM Labor and Technical Support including travel costs during the warranty period.

3.3.3 Vendor shall provide contractual options for an extended warranty. The contractor shall detail the warranty and maintenance support they will provide that meets and/or exceeds minimum requirements of the contract. The preference is for maintenance support that minimizes disruption to patient care while reducing workload. Maintenance support will be evaluated to determine if the vendor will reduce down-time during the warranty and post-warranty period. Contractors should provide information related to how the installed system will be supported; this includes any spares, repair parts and technical support that is included in the warranty, at or above contract requirements. The contractor shall provide the location(s) of all maintenance facilities capable of providing any needed support. The contractors should describe repair and preventative strategies they would offer for their system including a description of how they will expedite lead times as needed for repairs or replacement. If it is supported by technician(s) going to the Government location, then response times should be provided along with location of Service Office(s).

3.3.4 Vendor shall provide all relevant information and supplies that allow government BMET personnel to conduct maintenance to the device in the field, including the ability to replace system components to sustain items in good working condition. For routine maintenance, the items must be maintainable on-site at deployed field locations by the Government BMETs.

Examples of “routine maintenance” are actions such as lubrication, replacement of bolts, screws or other components, powering down/locking down at end of use and for storage, any calibration needs, and similar types of actions that sustain the equipment in good working condition. “Routine maintenance” does not refer to major repair actions nor to warranty repairs.

3.3.5 The contractor shall provide a full listing of support and repair parts and distinguish the items to be considered high-failure repair parts. The country of origin, availability, proprietary parts, and procurement accessibility of each item shall be provided on the list and added to ECAT upon contract award.

3.3.6 Contractor shall allow Army personnel to contact all manufacturers and/or contractors directly to request and verify information as well as information required to develop Army documentation to support the procurement and sustainment of the device. ***

3.3.7 Vendor shall notify the government, including but not limited to: the designated Contracting Officer and all technical points of contact, of all field change orders, alerts, recalls, and equipment notices affecting the system for the useful life of the system. ***

3.3.8 The Ultrasonic Unit Blood, Flow Detection shall be serviced and repaired using the minimum amount of specialized test, measurement, and diagnostic equipment and tools available at unit and support maintenance levels. Any proprietary TMDE shall be included as part of the configuration if applicable.

3.3.9 The vendor shall provide the organizational points of contact for maintenance and technical support including hours of operation, phone numbers, emails, and mailing address. Customer service is required as reach-back for technical support and potentially to order parts for replacement of consumables and/or repairs. The Contractor shall provide customer service and technical support, at minimum, during business hours at no additional cost to the Government. ***

3.4 SOFTWARE

3.4.1 Vendor shall provide software updates for the life of the system (if applicable).

3.4.2 Vendor shall provide a software obsolescence plan for addressing the maintenance of any third-party software that is no longer supported from the third-party vendor.

3.4.3 Device software, if applicable, that may require modification during system life shall be field upgradable by military Biomedical Equipment Technicians (BMET) using a computer interface, the Internet, or a CD supplied by the manufacturer without changing hardware components of the device. Manufacturer notification of product software modification and/or updates sold to customers is required. Outdated software shall not render the device unusable.

3.5 TRAINING

3.5.1 The contractor shall provide any necessary training to use, maintain, and calibrate the device within 10 days of delivery.

3.5.2 The contractor shall provide a training plan outlining the proper operation of the device, demonstrating its key features, and detailing the calibration process. The training plan shall include an outline of the amount of days and hours needed to complete User/Operator and BMET/Maintainer training; syllabus; OEM certifications; and schedule (e.g., maximum lead time from request for training to actual enrollment in the class).

Complete User/Operator Training and Maintainer Training is desired to be completed within one eight-hour day.

3.5.3 User/Operator Training and Maintainer Training shall be conducted at a single CONUS location or online. Training events shall include: principles of operation, preparation for use and installation, software applications training, startup/shutdown, operating instructions (control settings, start-up, normal operation, shutdown, and emergency shutdown), maintenance and servicing instructions (preventive and corrective), cleaning and lubrication, performance verification, inspection, troubleshooting, software updates and security patch instructions (if applicable), preparation for shipment and long term storage, safety hazard identification and mitigation, and required tools, test equipment, and consumables, as applicable.

The quotation shall include options for the onsite training at CONUS and OCONUS government locations if requested by the government. For the purposes of the quotation – the vendor shall propose options for on-site training in Texas, Georgia, Wisconsin, South Korea, Japan, and Germany and/or online training for a group of up to 6 personnel.

3.6 DOCUMENTATION

3.6.1 The contractor shall include operator and manufacturer service manuals, in both electronic and hard copy, with each system, that include:

Theory of Operation Troubleshooting instructions and videos All Maintenance and Calibration Requirements Illustrated Parts Breakdown with part numbers for each replaceable component Applicable schematics [electronic, pneumatic, hydraulic, etc.] for the device.

The vendor shall provide an electronic copy of the operator manual and electronic copy of the service manual with the quotation that shall be authorized to be placed on a government website for maintainers to use for the sustainment and maintainability of the system in an austere environment. The vendor shall provide any procedures, information, data, passwords, or calibration standards required to conduct repairs in the field by government trained personnel.

3.6.2 The vendor shall create, or provide access to existing on-line media (web-based) to all Army biomedical equipment repairers and operators. Online training (or on DVD) should include all the recommended preventive maintenance services, calibration and troubleshooting procedures necessary to operate and maintain the system. This training material must be added as a deliverable for the Army to use (upload) to DoD secured network to support the maintenance and operation of the device.

3.7 CYBERSECURITY ASSESSMENT (***)

3.7.1 The Government may be required to conduct a Risk Management Framework (RMF) analysis on all equipment intended for deployment as part of the FAT. DoD Instruction 8500.01, “Risk Management Framework (RMF)” supports cybersecurity risk analysis of device software, and generally applies to any equipment that includes electronics, particularly if there exists a possibility for wireless communications, and/or electronic upload/download of software or information. During the course of the RMF process, the Government will require system-specific information about the functionality of data transfer capabilities. The Government will submit questions, as needed, to the Contractor. The Contractor shall provide system specific information regarding data processed, stored, or transmitted by the equipment, as responses to Government queries, in support of the Government’s analysis within five (5) business days of each inquiry; the Contractor is not required to perform the RMF analysis. ***

To ascertain security compliance with United States Federal Government (USFG), Department of Defense (DoD), and Defense Health Agency (DHA) policies and directives, the DHA Cyber Logistics Center of Excellence (CyberLOG) requires the vendor complete a Medical Device Equipment Readiness Assessment (MDERA) Questionnaire upon award. ***

All Medical Systems/Devices are required to meet DoD cybersecurity and National Institute of Standards and Technology (NIST) standards. The information provided in the questionnaire will be used as a pre-procurement selection tool used to support all stakeholders working to achieve a Risk Management Framework (RMF) Authorization. Failure to disclose all required information, or misrepresentation of the proposed system’s capabilities, will result in the system being ineligible for purchase, or result in a breach of contract and cancellation of contract if discovered after award. ***

The information provided which includes data processing capabilities, current security posture, and level of compliance with the cybersecurity principles of Confidentiality, Integrity, and Availability will be used to identify the technical characteristics of the Medical System/Device and determine the level of effort and potential actions required prior to and during an RMF Assessment process, from a cybersecurity standpoint.

3.8 ANTITERRORISM/OPERATIONS SECURITY (AT/OPSEC)

3.8.1 Access and general protection/security policy and procedures. This standard language is for contractor employees with an area of performance within Army controlled installation, facility, or area. 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.

3.8.2 For contractors requiring Common Access Card (CAC). Before CAC issuance, the contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014-05. The contractor employee will be issued a CAC only if duties involve one of the following: (1) Both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) Remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) Physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

3.8.3 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. DoD Service Member or civilian employee at all times they are inside a U.S.

government facility.

3.8.4 Threat Awareness Reporting Program. For all contractors with security clearances. Per AR 381-12

Threat Awareness and Reporting Program (TARP),contractor employees must receive annual TARP training by a CI agent or other trainer as specified in 2-4b.

4. PERIOD OF PERFORMANCE/DELIVERY DATE:

The vendor shall deliver two (2) complete Ultrasonic Unit, Blood Flow Detection, with all its components and accessories, packaged and packed securely in one self-contained hardened case with closed cell foam within 45 calendar days of award. The unit shall consist of the fully configured system that meets all minimum requirements, vendor specifications, and other feature/items that were part of the vendor’s evaluated offer.

The Government reserves the right to award multiple contracts.

4.1 Place of Delivery:

Deliveries shall be FOB destination, to:

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

4.2 Inspection and Acceptance: Certification by the Government of satisfactory goods or services provided is contingent upon the Vendor performing in accordance with the terms and conditions of any resultant Contract/Order. Items determined to not be in accordance with the terms of the Contract/Order upon receipt inspection will be returned to the Vendor.

5. WAWF INSPECTOR/ACCEPTOR:

Name: Ms. Wendy M. Hagan Command: U.S. Army Medical Materiel Development Activity Agency: United States Army Street Address: 1430 Veterans Drive City, State and Zip code: Fort Detrick, MD 21702-5009 E-Mail: wendy.m.hagan2.civ@mail.mil Phone: (240) 457-1875 Office: (301) 619-4362

MINIMUM ESSENTIAL CHARACTERISTICS (MECs)

Original Date: 13 July 2022

Revised Date: N/A

Title: ULTRASONIC UNIT, BLOOD FLOW DETECTION

Requiring Activity/Agency Name: U.S. Army Medical Material Development Activity (USAMMDA)/Medical Modernization, Warfighter Deployed Medical Systems PMO

Program Name: Medical Modernization, Warfighter Deployed Medical Systems PMO

1. PURPOSE

The USAMMDA, Medical Modernization, Warfighter Deployed Medical Systems (WDMS) PMO requires an Ultrasonic Unit, Blood Flow Detection for use in the Role of Care 3 setting. The Ultrasonic Unit, Blood Flow Detection is used to assess blood flow in an artery prior to, during, or after surgery through the use of sound waves.

Transcutaneous blood flow assessments are critical to identifying arterial injuries. A critical step in repairing arterial injuries is to use Doppler directly on the repaired vessel to demonstrate restored flow prior to concluding surgery. In the early post-operative period, limb perfusion is monitored using transcutaneous Doppler to ensure restoration of flow and identification of changes in perfusion. Proper perioperative and intraoperative limb perfusion assessment is necessary for combat surgery. Delays in intervention may lead to loss of limb function up to and including amputation.

2. ESSENTIAL CHARACTERISTICS

The following essential characteristics must be met in order for the device to be considered acceptable.

No. Essential Characteristic (EC)

Threshold (T) Objective (O)

Food and Drug Administration (FDA) Regulatory Oversight

The system shall be cleared by the FDA with a 510(k) approval for human use if it is a Class II medical device.

If the system is Class I medical device, it shall be registered with the FDA for human use.

T=O

Intended Uses

The device shall be capable of use on sterile sites in intraoperative environments and on non-sterile sites such as intact skin.

3 Directionality The device shall be a non-directional Doppler.

The device shall be a bi-directional Doppler.

4 Probe Frequency The device shall support a probe frequency of 8 MHz.

T=O

5 Probe Shape The probe shall be pencil-style shaped. T=O

Probe Type

The probes shall be a durable probe compatible with sterile technique.

The device shall support the use of durable probes with sterile technique and disposable probes.

Output

The device shall contain a speaker for detection of audio output.

The device shall have a display screen as well as a speaker.

Power Source

The device shall be capable of operating on battery power or plugged into external power.

The device shall be capable of operating with a battery, rechargeable if possible.

Power Specifications

The device shall be able to operate using 110-120 VAC/60 Hz.

The device shall be able to operate using both of the following voltages:

110-120 VAC/60 Hz; 220

VAC/50 Hz 10 Weight, Device The device shall weigh no more than 8 lbs.

in its operational configuration.

The device shall weigh no more than 5 lbs. in its operational configuration.

Packaging

The supplier shall provide the system with all its components and accessories packed safely and securely in a self-contained harden case (e.g. Harding Pelican, ECS Case, and/or equivalent). The case shall have approved marked data plates with the following information:

a. National Stock Number(s) – Actual NSN(s) to be provided after award.

b. Item Unique Identification (IUID) on each system/unit in accordance with clause DFARS 252.211-7003, Item Unique Identification and Valuation (DEC 2013).

c. Inserts shall be of closed cell foam or similar insulating and protective material capable of sustaining the system throughout transport and environmental conditions.

The supplier shall provide the system with all its components and accessories packed safely and securely in a self-contained harden case with a pressure-equalization valve (e.g.

Harding Pelican, ECS Case, and/or equivalent). The case shall have approved marked data plates with the following information:

a. National Stock Number(s) – Actual NSN(s) to be provided after award.

b. Item Unique Identification (IUID) on each system/unit in accordance with clause DFARS 252.211-7003, Item

Unique Identification and Valuation (DEC 2013).

c. Inserts shall be of closed cell foam or similar insulating and protective material capable of sustaining the system throughout transport and environmental conditions.

d. Shall include a waterproof list of case contents with picture showing location and position of item in the case.

12 TAA Compliance The system shall be compliant with Trade Agreements Act (TAA) regulations.

3. CLINICAL/TECHNICAL: ADDITIONAL PERFORMANCE PARAMETERS:

These are desired Additional Performance Parameters (APPs) but are not essential. They allow for technical trade space and assist in best value determination. If met, these will be rated as strengths of the system.

No. Essential Characteristic (EC) Threshold (T) Objective (O)

Weight, Packaged

The system and all accessories shall come in one hardened transport case weighing no more than 15 lbs.

The system and all accessories shall come in one hardened transport case weighing no more than 10 lbs.

Authority to Operate (ATO)

If applicable, the system shall be able to obtain an Authority to Operate from the Defense Health Agency (DHA) that will be supported for the length of the contract.

(END)

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

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 45 dys. ADC 2 ARMY MMDA - MM

USAMMDA

1430 VETERANS DRIVE

FORT DETRICK MD 21702-5009

HT0986

0002 45 dys. ADC 1 (SAME AS PREVIOUS LOCATION)

0003 45 dys. ADC 2 (SAME AS PREVIOUS LOCATION)

0004 45 dys. ADC 2 (SAME AS PREVIOUS LOCATION)

0005 45 dys. ADC 2 (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.203-12 Limitation On Payments To Influence Certain Federal

Transactions

JUN 2020

52.204-7 System for Award Management OCT 2018 52.204-10 Reporting Executive Compensation and First-Tier

Subcontract Awards

JUN 2020

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 52.204-23 Prohibition on Contracting for Hardware, Software, and

Services Developed or Provided by Kaspersky Lab and Other Covered Entities

NOV 2021

52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment

NOV 2021

52.209-6 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment

NOV 2021

52.209-10 Prohibition on Contracting With Inverted Domestic Corporations

NOV 2015

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

DEC 2022

52.217-3 Evaluation Exclusive Of Options APR 1984 52.217-5 Evaluation Of Options JUL 1990 52.219-4 Notice of Price Evaluation Preference for HUBZone Small

Business Concerns

OCT 2022

52.222-3 Convict Labor JUN 2003 52.222-19 Child Labor -- Cooperation with Authorities and Remedies DEC 2022 52.222-21 Prohibition Of Segregated Facilities APR 2015 52.222-22 Previous Contracts And Compliance Reports FEB 1999 52.222-25 Affirmative Action Compliance APR 1984 52.222-26 Equal Opportunity SEP 2016 52.222-35 Equal Opportunity for Veterans JUN 2020 52.222-36 Equal Opportunity for Workers with Disabilities JUN 2020 52.222-37 Employment Reports on Veterans JUN 2020 52.222-50 Combating Trafficking in Persons NOV 2021 52.223-18 Encouraging Contractor Policies To Ban Text Messaging

While Driving

JUN 2020

52.225-1 Buy American--Supplies OCT 2022 52.225-13 Restrictions on Certain Foreign Purchases FEB 2021

52.232-33 Payment by Electronic Funds Transfer--System for Award Management

OCT 2018

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

MAR 2023

52.233-1 Disputes MAY 2014 52.233-1 Alt I Disputes (May 2014) - Alternate I DEC 1991 52.233-3 Protest After Award AUG 1996 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 52.239-1 Privacy or Security Safeguards AUG 1996 52.242-15 Stop-Work Order AUG 1989 52.243-1 Changes--Fixed Price AUG 1987 52.247-34 F.O.B. Destination NOV 1991 52.249-1 Termination For Convenience Of The Government (Fixed

Price) (Short Form)

APR 1984

52.253-1 Computer Generated Forms JAN 1991 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights DEC 2022 252.203-7005 Representation Relating to Compensation of Former DoD

Officials

SEP 2022

252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7012 Safeguarding Covered Defense Information and Cyber

Incident Reporting

JAN 2023

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

JAN 2023

252.204-7016 Covered Defense Telecommunications Equipment or Services -- Representation

DEC 2019

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

252.204-7019 Notice of NIST SP 800-171 DoD Assessment Requirements MAR 2022 252.204-7020 NIST SP 800-171 DoD Assessment Requirements JAN 2023 252.211-7008 Use of Government-Assigned Serial Numbers SEP 2010 252.213-7000 Notice to Prospective Suppliers on Use of Supplier

Performance Risk System in Past Performance Evaluations

SEP 2019

252.223-7008 Prohibition of Hexavalent Chromium JAN 2023 252.225-7001 Buy American And Balance Of Payments Program--Basic JAN 2023 252.225-7007 Prohibition on Acquisition of Certain Items from Communist

Chinese Military Companies

DEC 2018

252.225-7012 Preference For Certain Domestic Commodities APR 2022 252.225-7021 Trade Agreements--Basic JAN 2023 252.225-7036 Buy American--Free Trade Agreements--Balance of

Payments Program--Basic

JAN 2023

252.225-7048 Export-Controlled Items JUN 2013 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

252.225-7972 (Dev) Prohibition on the Procurement of Foreign-Made Unmanned Aircraft Systems (DEVIATION 2020-O0015)

MAY 2020

252.225-7973 (Dev) Prohibition on the Procurement of Foreign-Made Unmanned Aircraft Systems - Representation (DEVIATION 2020- O0015)

MAY 2020

252.226-7002 Represenation for Demonstration Project for Contractors Employing Persons with Disabilities

DEC 2019

252.227-7015 Technical Data--Commercial Products and Commercial Services

JAN 2023

252.227-7037 Validation of Restrictive Markings on Technical Data JAN 2023 252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

DEC 2018

252.232-7010 Levies on Contract Payments DEC 2006 252.243-7999 (Dev) Section 3610 Reimbursement. (DEVIATION 2020-O0021) AUG 2020 252.244-7000 Subcontracts for Commercial Products or Commercial

Services

JAN 2023

252.246-7008 Sources of Electronic Parts JAN 2023 252.247-7023 Transportation of Supplies by Sea JAN 2023

CLAUSES INCORPORATED BY FULL TEXT

52.204-17 OWNERSHIP OR CONTROL OF OFFEROR (AUG 2020)

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

Commercial and Government Entity (CAGE) code means—

(1) An identifier assigned to entities located in the United States or its outlying areas by the Defense Logistics Agency (DLA) Commercial and Government Entity (CAGE) Branch to identify a commercial or government entity by unique location; or

(2) An identifier assigned by a member of the North Atlantic Treaty Organization (NATO) or by the NATO Support and Procurement Agency (NSPA) to entities located outside the United States and its outlying areas that the DLA Commercial and Government Entity (CAGE) Branch records and maintains in the CAGE master file. This type of code is known as a NATO CAGE (NCAGE) code.

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.

(b) The Offeror represents that it [ ___ ] has or [ ___ ] does not have an immediate owner. If the Offeror has more than one immediate owner (such as a joint venture), then the Offeror shall respond to paragraph (c) and if applicable, paragraph (d) of this provision for each participant in the joint venture.

(c) If the Offeror indicates ``has'' in paragraph (b) of this provision, enter the following information:

Immediate owner CAGE code:

Immediate owner legal name: ___

(Do not use a ``doing business as'' name)

Is the immediate owner owned or controlled by another entity?:

[ ___ ] Yes or [ ___ ] No.

(d) If the Offeror indicates ``yes'' in paragraph (c) of this provision, indicating that the immediate owner is owned or controlled by another entity, then enter the following information:

Highest-level owner CAGE code:

Highest-level owner legal name:

(Do not use a ``doing business as'' name)

(End of provision)

52.204-20 Predecessor of Offeror (AUG 2020)

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

Commercial and Government Entity (CAGE) code means--

(1) An identifier assigned to entities located in the United States or its outlying areas by the Defense Logistics Agency (DLA) Commercial and Government Entity (CAGE) Branch to identify a commercial or government entity by unique location; or

(2) An identifier assigned by a member of the North Atlantic Treaty Organization (NATO) or by the NATO Support and Procurement Agency (NSPA) to entities located outside the United States and its outlying areas that the DLA Commercial and Government Entity (CAGE) Branch records and maintains in the CAGE master file. This type of code is known as a NATO CAGE (NCAGE) code.

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

Successor means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term “successor” does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

(b) The Offeror represents that it [____] is or [____] is not a successor to a predecessor that held a Federal contract or grant within the last three years.

(c) If the Offeror has indicated “is” in paragraph (b) of this provision, enter the following information for all predecessors that held a Federal contract or grant within the last three years (if more than one predecessor, list in reverse chronological order):

Predecessor CAGE code: ____ (or mark “Unknown”).

Predecessor legal name: ____.

(Do not use a “doing business as” name).

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…