W81XWH20Q0111- Amendment 02.pdf

W81XWH20Q0111

COMBINED SYNOPSIS/SOLICITATION INSTRUCTIONS

1. Original Issue Date: 13 July 2020

2. Close Date: 13 August 2020 10:00 AM Eastern Time 25 August 2020 10:00 AM Eastern Time

3. Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA) located at 820 Chandler Street, Fort Detrick, MD 21702.

4. Requiring Activity: U.S. Army Medical Materiel Development Activity (USAMDA)

5. Subject: Human Ultrasound, Portable

6. Solicitation Number: W81XWH20Q111

7. Description of Requirement: USAMMDA, requires replacement of the current generation of Human Ultrasound, Portable fielded systems across the Army’s deployed forces in Roles of Care 2 and 3. This requirement is for the establishment of one Blanket Purchase Agreement for Human UltraSound Portable Systems.

7.1. This is a combined synopsis/solicitation issued as a Request for Quote (RFQ) for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

7.2. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020-07; effective 02 July 2020.

7.3. This acquisition is being competed using full and open competition. The North American Industry Classification System (NAICS) code is 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing with a Size Standard of 1,250 employees.

7.4. Contract award shall be made on a competitive best value basis using “Lowest Price, Technically Acceptable (LPTA)” approach.

7.5. The Contract Line Item Numbers (CLINs) and items, quantities, units of measure and descriptions are identified under the Supplies/Services Section of the RFQ.

7.6. The anticipated required delivery date is 30 days ADC with shipping Free On Board (FOB) Destination to: The US Army Medical Materiel Development Agency, Veterans Dive, Fort Detrick, MD 21702.

7.7 Offerors responding to this combined synopsis/solicitation shall include a completed copy of the provision at 52.212-3 Offeror Representations and Certifications – Commercial Items with its proposal.

8. Point of Contact: The Point of Contact (POC) for this acquisition is Ms. Rebecca Wisner Contract Specialist, rebecca.c.wisner.civ@mail.mil; No telephone calls will be accepted.

9. Instructions for the Preparation and Submission of Quotes

9.1 Quotes shall be prepared in accordance with (IAW) this solicitation and FAR provision 52.212-1, Instructions to Offerors – Commercial Items including the (m) Addendum, which is included in the attached RFQ.

9.2. All quotes shall be evaluated in accordance with the Evaluation Criteria identified in the Addendum to FAR 52.212-2 Evaluation – Commercial Items within the Contract Clauses Section.

9.3. The FAR clause 52.212-4 Contract Terms and Conditions – Commercial Items applies to this acquisition.

Additional contract requirements and terms and conditions are identified in the attached RFQ.

9.4. The FAR clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders

– Commercial Items, applies to this acquisition. See the clause for additional FAR clauses cited and marked which are applicable to this acquisition.

9.5. The Government reserves the right to reject any or all proposals, and to award no contract at all, depending on the quality of the quotes(s) submitted and the availability of funds.

9.6. Questions: Questions shall be submitted via e-mail to Ms. Rebecca Wisner, Contract Specialist, rebecca.c.wisner.civ@mail no later than 28 July 2020 at 10:00 AM Eastern Time. Questions received after this date will not be accepted. An Amendment to the solicitation will be posted to BetaSam, https://beta.sam.gov/ to address the questions received. Only one (1) set of questions per Contractor will be accepted by the Government. No telephone calls will be accepted.

9.7 Quotes: Quotes in response to this solicitation are due via e-mail no later than 13 August 2020 at 10:00 AM 25 August 2020 10:00 AM EST Eastern Time to Ms. Rebecca Wisner, Contract Specialist, rebecca.c.wisner.civ@mail.mil; late proposals will not be accepted.

9.8. The Offeror shall agree to honor proposed prices for 60 calendar days from the due date for receipt of quotes.

https://beta.sam.gov/ mailto:rebecca.c.wisner.civ@mail.mil

DESCRIPTION OF REQUIREMENT

DESCRIPTION OF REQUIREMENT

1. BLANKET PURCHASE AGREEMENT

1.1. The Government intends to one (1) Blanket Purchase Agreement (BPA) IAW FAR 13.303 on a competitive basis, using the best value Lowest Price Technically Acceptable (LPTA) source selection procedures among price and non-price factors IAW FAR 15.101-2. The Government intends to evaluate and award without discussion;

however, the Government reserves the right to conduct discussions. If discussions are require, they will be conducted with Offerors IAW FAR 15.306.

1.2. The resultant BPAs will be issued on a DD 1155 and will include Contract Line Items Numbers (CLINs). As a result, no CLINs are included in the solicitation. The Federal Supply Code (FSC) for this BPA is 6525: Electro medical and Electrotherapeutic Apparatus Manufacturing.

1.3. The resultant Call Orders off the BPA will be Firm Fixed Price (FFP).

1.4. The ordering period for the BPA awarded as a result of this solicitation is for five (5) years. IAW FAR 13.303- 6(b) The Contracting Officer shall review at least annually the resultant BPA and, if necessary, update at that time to maintain awareness of changes in market conditions, sources of supply, and other pertinent factors that may warrant making new arrangements with different suppliers or modifying existing arrangements.

2. EXTENT OF OBLIGATIONS

2.1. The Government is obligated only to the extent of authorized purchases/Call Orders ordered and received under the resultant BPA.

2.2. The maximum amounts identified in the Statement of Need (SON) Section 3.1.1. below shall not be construed as a commitment on the part of the Government for guaranteed Call Order Value.

2.3. The cumulative ceiling amount of all Call orders issued against the resultant BPAs for the five (5) year ordering shall not exceed $530,000.00.

3. ISSUANCE OF CALL ORDERS

3.1. All required supplies provided under the BPA shall be set forth in individual Call Orders. A Call Order Request for Quote (CORFQ) shall be issued to the BPA Holder for quantities, description pricing and estimated delivery. All Call Orders will be awarded LPTA and IAW the Statement of Need (SON) and the terms and conditions of the resultant BPA.

3.2 IAW Army Federal Acquisition Regulation Supplement (AFARS) 5113.303-5(b)(2), individual Call Orders shall not exceed $530,000.00.

4.0 INVOICING:

To be determined at the BPA Call order Level.

STATEMENT OF NEED

STATEMENT OF NEED

Original Date: February 6, 2020

Revised Date: June 1, 2020

Title: HUMAN ULTRASOUND, PORTABLE (LIN: U26813) 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, Deployed Medical Systems PMO requires replacement of the current generation of fielded systems across the Army’s deployed forces in Roles of Care 2 and 3.

The Human Ultrasound system is to provide imaging for surgical, orthopedic, critical care, and emergency care procedures in deployed military settings, primarily to treat service members injured in combat or non-combat accidents. The currently fielded Human ultrasound Portable system is no longer procurable due to discontinuation by the manufacturer. Without the Human Ultrasound Portable System, providers would lack the means to accurately diagnose and locate trauma, impairing their ability to intervene with appropriate treatment. This would negatively affect patient outcomes, and compromise patient health and safety that may cause death.

2. HISTORY

The Sonosite M-Turbo has been in the Army’s inventory since 2010. A replacement product for the currently fielded Human Ultrasound Portable system is required. The current device has been discontinued by the manufacturer and is no longer procurable.

3. STATEMENT OF NEED SCOPE OF WORK

3.1 Task 1 – Supply Support.

1. The Contractor shall provide approximately 11 Ultrasound systems during the ordering period of the resultant BPA.

2. The Contractor shall ensure that each system includes all accessories and consumables.

3. The Contractor shall provide a full listing of repair parts, accessories and consumables. Any proprietary, or required special tools shall be included.

4. The Contractor shall identify all items considered to be high-failure repair parts. Mean time between failure (MTBF) and mean time to repair (MTTR) shall be provided for these parts.

5. The following additional information shall be furnished for the system and for all proposed parts:

• Name / Description

• Part Number

• Weight

• Dimensions

• Price

• ECRI Device Code

• Shelf Life

• Picture

• Country of origin

• MTBF, if available

• MTTR, if available

6. The Contractor shall have the complete ultrasound system, with all its components and accessories, packaged and packed safely and securely in one self-contained hardened case (e.g., Hardigg, Pelican, ECS Case, or equivalent) with closed-cell foam. The case shall have the approved marked data plates with the following information:

• Nomenclature – Nomenclature to be provided at time of award

• National Stock Number (NSN) – Actual NSN(s) to be provided at time of award

• Manufacturer

• Model

• Item Unique Identification (IUID) on each system/unit in accordance with clause DFARS

252.211-7003, Item Unique Identification and Valuation (DEC 2013).

7. The Contractor shall notify the USAMMDA, Technical Point of Contact (TPOC) and the Contracting Officer when the system and parts are coming to the end useful life, or that it is no longer available for procurement within 12 months of such date.

8. The Contractor shall allow the Army Depot personnel to contact the manufacturer of the ultrasound system to request information and verify data, as required.

3.2 Task 2 – Technical Data Accessibility.

1. Media Availability (Access): Vendor shall provide access to all technical data.

2. Technical Data Accessibility: DoD operators, Clinical Staff, and maintainers shall have access to application software, diagnostic software, operator, and service technical data required to operate and maintain the system in a deployed environment.

3.3 Task 3 – Training and Training Support

1. The Contractor shall provide a Training Plan and Program for Department of Defense (DoD)

Clinical Staff operator, and maintainer for the proposed system as configured to include the following topics: principles of operation, preparation for use and installation, software applications training, startup/shutdown, operating instructions, maintenance and servicing instructions, 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.

2. The Contractor shall provide all available user and maintainer manuals, training videos, and documentation. Manuals should comply with MIL-PRF-32216A.

Required supplemental materiel shall be provided for manuals that do not comply with this performance specification.

3. The Contractor shall offer, as part of the contract, training options for both individual and group service personnel that can be ordered as needed.

4. The online (and/or DVD) training should include all the preventive and corrective maintenance services necessary to operate, maintain, and sustain the system its useful life.

3.4 Task 4 – Maintenance Planning and Management

1. The Ultrasound system must be compliant with the most current U.S. Trade Agreement Act

(TAA) policies and regulations.

2. The Contractor shall provide a two-level maintenance concept plan (for field and sustainment maintenance support) allowing the proposed system to be reliable, maintainable, and sustainable at the government’s lowest level of maintenance support possible (Field level maintenance).

• FIELD LEVEL: Field support is provided by the operator and the organization's Biomedical Equipment Specialist (BES). Operator tasks include the care and cleaning of exterior surfaces, components, and accessories and the replacement of bulbs, tubing, etc., that are easily accessible and do not require specialized tools or test equipment. The maintenance is accomplished by a BES with basic tools and Test Measurement Diagnostic Equipment (TMDE).

• SUSTAINMENT LEVEL: Sustainment support is provided at the depot.

This level of maintenance requires specialized tools, TMDE, and/or training due to the complexity of maintenance/repair requirements.

3. The Contractor shall provide a maintenance strategy plan for when system is stored for short-

(less than 6 months) and long-term (more than six months).

4. The Contractor shall provide a warranty for a period of 12 months from time of delivery.

Warranty shall include all parts, software updates (if applicable), labor, technical support, and shipping during the warranty period. Shall be serviced and repaired using the minimum amount of specialized test, measurement and diagnostic equipment (TMDE) and tools available at unit and support maintenance levels.

5. The Contractor shall provide Operator/Maintainer telephone support during the hours of 8:00

AM to 5:00 PM for the entire life of the system.

6. The Contractor shall notify USAMMDA Technical Point of Contact (TPOC) and the Contracting Officer of all field change orders, alerts, recalls and equipment notices affecting the system for the useful life of the system.

4. CONTRACT ADMINISTRATION

The Contract Administration Team will consist of the following members:

4.1. The Contracting Officer will have overall responsibility for administering the Contract. The

Contracting Officer is the only person authorized to obligate the Government and make changes to the Contract. The Contracting Officer will manage Contract administration and performance delivery surveillance supported by Contract administrators and the Technical Point of Contact

(TPOC).

4.2. The TPOC will be appointed in writing and will be directly responsible to the Contracting Officer.

The TPOC serves as the Government’s point-of-contact for Contract-level coordination and administration. The TPOC will assist the Contracting Officer in overseeing the administration of the Contract as appropriate; assist in resolving issues; initiate changes; notify the Contracting Officer of any disputes or contractual issues that cannot be resolved; and conduct other activities as specified by appointment.

5. PERIOD OF PERFORMANCE/DELIVERY DATE:

The anticipated ordering period of this BPA is five years.

This will include the purchase of the COTS products. In addition, it will include supply support, technical data accessibility, training & training support, and maintenance planning and management, as stated above.

FY20 FY21 FY22 FY23 FY24

Projected Number of Systems

3 0 0 7 1

Shipping: The primary shipping destination will be Tracy Army Depot

DODAAC: W62SEV

US Army Medical Materiel Agency Medical Maintenance Operations Division Tracy Site, Building T-255 25600 S. Chrisman Road Tracy, CA 95304-9150

ATTN: Anthony Zapanta

Other shipment locations include:

USAMMDA

1430 Veterans Drive Fort Detrick, MD 21702

6. FEDERAL HOLIDAYS

The following Federal holidays are observed and no work or deliveries shall occur on the dates specified.

Any of the below holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday.

a. New Year’s Day, 1 January

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

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

d. Memorial Day, last Monday in May

e. Independence Day, 4 July

f. Labor Day, 1st Monday in September

g. Columbus Day, 2nd Monday in October

h. Veteran’s Day, 11 November

i. Thanksgiving Day, 4th Thursday in November

j. Christmas Day, 25 December

7. DELIVERABLES

SON Reference Title/Description Due

3.1.3 Supply Support The Contractor shall provide a full

listing of repair parts, accessories and consumables. Any proprietary tools shall be included.

RFQ

3.1.4 Supply Support The Contractor shall identify all items

considered to be high-failure repair parts. Mean time between failure (MTBF) and mean time to repair (MTTR) shall be provided for these

RFQ

parts.

3.1.5 Supply Support The following additional information

shall be furnished for the system and for all proposed parts:

• Name / Description

• Part Number

• Weight

• Dimensions

• Price

• ECRI Device Code

• Shelf Life

• Picture

• Country of origin

• MTBF, if available

• MTTR, if available

RFQ

3.2.1 Technical Data

Accessibility

Media Availability (Access): Vendor shall provide access to all technical data.

Award

3.2.2 Technical Data

Accessibility

Technical Data Accessibility: DoD operators, Clinical Staff, and maintainers shall have access to application software, diagnostic software, operator, and service technical data required to operate and maintain the system in a deployed environment.

Award

3.3.1 Training and

Training Support

The Contractor shall provide a Training Plan and Program for Department of Defense (DoD) Clinical Staff operator, and maintainer for the proposed system

RFQ

3.3.2 Training and

Training Support

The Contractor shall provide all available user and maintainer manuals, training videos, and documentation.

RFQ

3.4.2 Maintenance

Planning and Management

The Contractor shall provide a two-level maintenance concept plan

RFQ

3.4.3 Maintenance

Planning and Management

The Contractor shall provide a maintenance strategy plan for when system is stored for short- (less than 6 months) and long-term (more than six months).

RFQ

MINIMUM ESSENTIAL CHARACTERIST

MINIMUM ESSENTIAL CHARACTERISTICS (MECs)

Title: HUMAN ULTRASOUND, PORTABLE (LIN: U26813)

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, Deployed Medical Systems PMO requires to replace the current generation of fielded equipment and creating standardization across the Department of Defense (DoD). The standardization is estimated to last 10 years or as long as the selected system is available commercially and meets the Services requirements, whichever is longer.

The Human Ultrasound system is to provide radiographic and fluoroscopic imaging in surgical, orthopedic, critical care, and emergency care procedures in deployed military settings, primarily to treat service members injured in combat or non-combat accidents. The currently fielded Human ultrasound Portable system is no longer procurable due to discontinuation by the manufacturer. Without the Human Ultrasound Portable System, Radiologists, Surgeons and clinicians would lack the means to accurately diagnose and locate trauma, impairing their ability to intervene with appropriate treatment. This would negatively affect patient outcomes, and compromise patient health and safety that may cause death.

2. ESSENTIAL CHARACTERISTICS

These characteristics are essential and must be met in order for the device to be considered acceptable. The threshold

(T) is the minimum acceptable essential characteristic value while the objective is a desired level of performance above the threshold.(REMOVED)

Number Parameter Minimum Requirement

1) Regulatory Approval

Shall be FDA approved as a medical device prior to issuance of the first Delivery Order.

2) FAST Capable Shall be capable of performing Focused Assessment with Sonography in Trauma (FAST) exams.

3)

Real-time Physiological

Imaging

Shall be capable of real-time imaging of the:

1) abdomen to include urogenital and body wall

2) thorax

3) pelvis

4) heart

5) extremities (musculoskeletal)

6) neck

7) eye/head

4) Color Doppler Shall be capable of measurement of peripheral vessels with Color Flow Doppler and Color Doppler capabilities.

5)

Modes and Functions

Shall have the following capabilities:

1) adjustable depth

2) M-Mode

3) B-Mode

4) Doppler review

5) cine loop

6) movie clip

6) Digital Signal Processing Shall have noise processing and artifact reduction capabilities.

7) Digital Scan Converter

Shall have a digital scan converter with at least a 512 X 512 matrix, displaying at least 64 gray shades.

8) Caliper Measuring Tool Shall have, at a minimum, a single caliper (two point) measurement tool.

9) Adjustable Gain Shall have adjustable gain capabilities.

10) Image Capabilities Shall have zoom, pan, and freeze capabilities.

11) Power System should be able to operate/charge on standard 110/220V, 50/60 Hz power supplies.

12)

Probe Capability

- Shall have multi-frequency Linear Array probe capabilities.

- Shall have multi-frequency Convex Array probe capabilities.

- Shall have multi-frequency Phased/Vector Array probe capabilities.

13) Probe Ingress Protection Shall be ingress protection (IP) rated IPx2.

14) Cybersecurity Assessment (RMF)

System shall maintain an Authority to Operate (ATO) based on the DoD’s Risk Management Framework (RMF).

15) Software License System shall include an enterprise software license that does not require an external device or key to operate.

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

CLAUSES INCORPORATED BY REFERENCE

52.202-1 Definitions NOV 2013 52.203-3 Gratuities APR 1984 52.203-12 Limitation On Payments To Influence Certain Federal

Transactions

JUN 2020

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 JUL 2016 52.204-18 Commercial and Government Entity Code Maintenance JUL 2016 52.204-24 Representation Regarding Certain Telecommunications and

Video Surveillance Services or Equipment.

DEC 2019

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

AUG 2019

52.204-26 Covered Telecommunications Equipment or Services-- Representation.

DEC 2019

52.212-4 Contract Terms and Conditions--Commercial Items OCT 2018 52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.246-16 Responsibility For Supplies APR 1984 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7003 Agency Office of the Inspector General AUG 2019

252.203-7005 Representation Relating to Compensation of Former DoD Officials

NOV 2011

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting

DEC 2019

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

MAY 2016

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

DEC 2019

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

DEC 2019

252.223-7008 Prohibition of Hexavalent Chromium JUN 2013 252.225-7001 Buy American And Balance Of Payments Program-- Basic DEC 2017 252.225-7012 Preference For Certain Domestic Commodities DEC 2017 252.225-7021 Trade Agreements--Basic SEP 2019 252.225-7052 Restriction on the Acquisition of Certain Magnets and

Tungsten.

DEC 2019

252.227-7015 Technical Data--Commercial Items FEB 2014 252.227-7037 Validation of Restrictive Markings on Technical Data SEP 2016 252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

DEC 2018

252.232-7010 Levies on Contract Payments DEC 2006 252.243-7002 Requests for Equitable Adjustment DEC 2012 252.244-7000 Subcontracts for Commercial Items JUN 2013 252.247-7023 Transportation of Supplies by Sea FEB 2019

CLAUSES INCORPORATED BY FULL TEXT

52.204-17 OWNERSHIP OR CONTROL OF OFFEROR (JUL 2016)

(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;

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 (JUL 2016)

(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;

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).

52.209-11 REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT TAX LIABILITY OR A

FELONY CONVICTION UNDER ANY FEDERAL LAW (FEB 2016)

(a) As required by sections 744 and 745 of Division E of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235), and similar provisions, if contained in subsequent appropriations acts, the Government will not enter into a contract with any corporation that--

(1) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless an agency has considered suspension or debarment of the corporation and made a determination that suspension or debarment is not necessary to protect the interests of the Government; or

(2) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless an agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government.

(b) The Offeror represents that--

(1) It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and

(2) It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.

52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (JUN 2020)

Includes (m) Addendum

(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 which submits an offer in its own name, but which proposes to furnish an item which it did not itself manufacture, is 500 employees.

(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 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 subpart 4.10 of the Federal Acquisition Regulation), or alternative commercial items 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 specifications, standards, and commercial item descriptions cited in this solicitation may be obtained for a fee by submitting a request to--GSA Federal Supply Service Specifications Section, Suite 8100, 470 East L'Enfant Plaza, SW, Washington, DC 20407, Telephone (202) 619-8925, Facsimile (202) 619-8978.

(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a single copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained free of charge by submitting a request to the addressee in paragraph (i)(1)(i) of this provision.

Additional copies will be issued for a fee.

(2) Most unclassified Defense specifications and standards may be downloaded from the following ASSIST websites:

(i) ASSIST (https://assist.dla.mil/online/start/).

(ii) Quick Search (http://quicksearch.dla.mil/).

(iii) ASSISTdocs.com (http://assistdocs.com).

(3) Documents not available from ASSIST may be ordered from the Department of Defense Single Stock Point (DoDSSP) by--

(i) Using the ASSIST Shopping Wizard (https://assist.dla.mil/wizard/index.cfm);

(ii) Phoning the DoDSSP Customer Service Desk (215) 697-2179, Mon-Fri, 0730 to 1600 EST; or

(iii) Ordering from DoDSSP, Building 4, Section D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, Telephone

(215) 697-2667/2179, Facsimile (215) 697-1462.

(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 items, the make and model of the item 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.

(m) ADDENDUM https://assist.dla.mil/online/start/ http://quicksearch.dla.mil/ http://assistdocs.com/ https://assist.dla.mil/wizard/index.cfm http://www.sam.gov/ http://www.sam.gov/

M.1 CONTRACT

The Government intends to award one (1) Blanket Purchase Agreement (BPA) for a five (5) year ordering period for an estimated quantity of eleven (11) Human Ultrasound, Portable systems. The BPA will utilize Firm-Fixed Price (FFP) Contract Line Item Numbers (CLINs).

M.2. TECHNICAL QUESTIONS

Questions are due no later than 10:00 AM Eastern Time on 28 July 2020. Questions shall be submitted to Rebecca Wisner at rebecca.c.wisner.civ@mail.mil. An amendment to the solicitation will be posted to https://beta.sam.gov/ in order to address the questions received. Please note that only one (1) set of questions per Offeror will be accepted by the Government.

M.3. INSTRUCTIONS FOR THE PREPARATION AND SUBMISSION OF QUOTES

Failure to submit all documents concurrently and in accordance with these instructions may render a quote “Unacceptable.” Quotes should provide a minimum offer acceptance period of 60 days from the end of the solicitation closing date (including an agreement to hold the prices in offer firm).

The proposal shall be submitted electronically via e-mail to rebecca.c.winser.civ@mail.mil no later than 10:00 AM Eastern Time on 13August 2020 25 August 2020. The Offeror is responsible for ensuring receipt by the POC.

Late proposals will not be accepted.

M.4. PROPOSAL EVALUATION

To aid in evaluation, quotes shall be practical, specific, complete, and logically assembled. The quotes shall be in a clear, concise format satisfying all requirements of this solicitation. It shall be in sufficient detail to demonstrate a clear understanding of the solicitation requirements.

M.5. THE QUOTE

The overall quote shall consist of two (2) separate Volumes, individually titled. Each copy of each Volume should be appropriately titled as follows:

Proposal Volumes Volumes Titles Page Limitation

Volume I Executive Summary, Executed Solicitation Documents and Pricing

N/A

Volume II Technical Compliance to MEC’s and Deliverables N/A

M.6. ADDITIONAL PROPOSAL SUBMITTAL INFORMATION

All commitments made by the Offeror in the proposal will become a part of the resultant contract. Data submitted with each proposal should be complete and concise. Any reliance on promotional brochures is unacceptable.

M.7. CONTENT OF PROPOSAL VOLUMES

The Offeror shall submit the content of proposal sections for the evaluation of the Offeror’s non-price evaluation factors and price evaluation factors IAW (m) ADDENDUM of this Solicitation.

mailto:rebecca.c.wisner.civ@mail.mil https://beta.sam.gov/ mailto:rebecca.c.winser.civ@mail.mil

The Government will evaluate only one quote from each prime Offeror; therefore, the Government will not accept alternate quotes.

The Offeror’s proposal is presumed to represent the Offeror’s best effort in response to the Solicitation, as an award may be made without discussions.

M.7.1 VOLUME I – EXECUTIVE SUMMARY, EXECUTED SOLICITATION DOCUMENTS and

PRICING

Volume 1 shall be broken into three (3) sections; Executive Summary, Executed solicitation documents and Pricing.

EXECUTIVE SUMMARY:

The Executive Summary shall not exceed one (1) page and should briefly summarize the content and identify the key points of the Offeror’s Technical Proposal.

The Offeror shall include at least one (1) point of contact who is authorized to hold discussions/negotiations with the Government and who has the full authority to bind the Offeror to a contract. The required informational fields include: First name, last name, title, e-mail address, and phone number. Please also include the entity’s Commercial and Government Entity Code, or CAGE Code.

EXECUTED SOLICITAITON DOCUMENTS:

Offeror shall also include a signed copy of the SF1449 solicitation and signed amendments (if any), completed Representations and Certification as identified in the Combined Synopsis/Solicitation Instructions to Offerors.

PRICING:

The Offeror shall provide a price proposal which includes firm-fixed pricing for all items detailed in this solicitation.

The Offeror should propose its preferred customer pricing (to include any discounts) and pricing commensurate with prices paid for other Government and commercial contracts.

It is expected that there will be adequate price competition; therefore, the Offeror is not required to certify cost or pricing data IAW FAR 15.403-1(c). However, if after receipt of the proposals, the Contracting Officer determines that data other than certified cost or pricing data is required, the Offeror shall provide.

M.7.2 .SECTION II –TECHNICAL COMPLIANCE AND DELIVERABLES

All sections of the Offeror’s proposal shall make direct reference to the USAMMDA Human Ultrasound, Portable SON, specification paragraph numbers. Statements such as “will comply”, “meets the intent of”, or “we intend to meet the requirements” and the like, will not suffice for evaluation purposes.

Volume II shall be broken up into two (2) sections: Technical Compliance and Deliverables further defined below.

TECHNICAL COMPLIANCE:

The Offeror’s proposal shall describe how the Offeror’s proposed Human Ultrasound, Portable device will successfully satisfy all of the minimum essential characteristic (MEC) threshold requirements contained in the Statement of Need (SON). Threshold requirements are considered minimums. Specifically, the technical proposal shall describe the Offeror’s proposed Human Ultrasound, Portable and explain how it complies with each element of the SON (located starting on page3 of the solicitation), MEC thresholds (located on page 8 of the solicitation).

DELIVERABLES:

The Offeror shall submit all DELIVERABLES identified as Due at RFP (located on page 7 of the solicitation) Failure to complete and submit DELIVERABLES identified as Due at RFP, will render the Offeror’s proposal “Unacceptable”.

(End of Clause)

52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014)

a. Basis for Award: Award of this contract will be made on a competitive best value basis using the “lowest price, technically acceptable” basis. Proposals will be evaluated to identify all Offerors whose proposals are technically acceptable in accordance with the RFP and the evaluation criteria set forth below. Award will be made to the Offeror from the pool of technically acceptable proposals, whose cost/price is lowest. Technical acceptability will be determined by evaluating Technical Capabilities/Specifications and Past Performance. All technical evaluation criteria must be rated Acceptable to be considered for award. Each Offeror must fully document and substantiate a cross mapping of their cost approach as it equates to the technical approach listed in the evaluation criteria. Please note that unsubstantiated costs that are considered unrealistic or unsupported or both may cause the overall technical evaluation to be rated Unacceptable.

b. Evaluation Criteria: Each Offeror’s quote will be evaluated using the following criteria.

Acceptable: A proposal is acceptable if it demonstrates that the Offeror can provide a Human Ultrasound System with the characteristics as stated in the Minimum Essential Characteristics (MEC’s) document.

Unacceptable: A proposal will be deemed unacceptable if the Offeror fails to demonstrate the ability to meet the stated performance standards, or fails to provide the requirements listed above, or offers a technical approach that either does not meet and/or demonstrate an understanding of the requirements outlined in the PWS. If any of the following non-cost/price evaluation factors receives an individual rating of “Unacceptable”, the entire proposal will be deemed “Unacceptable”.

(1) Technical Capabilities/Specifications/Salient Characteristics: The degree to which the

Offeror’s technical proposal demonstrates that the offeror can provide the requested Human Ultrasound System with the requested technical capabilities/specifications and recurring maintenance support described in the RFP and can meet the delivery schedule.

(2) Cost/Price Evaluation: The Government will conduct an appropriate cost/price analysis to determine whether prices are fair and reasonable.

Technical and past performance, when combined, are more important than price.

(c) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(d) 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.