Combined_Sol-Syn_NIH-CC-17-00513.pdf

Combined Synopsis/Solicitation Number NIH-CC-17-00513 Ultrasound Machine

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal

Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for

Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued.

Responses to combined synopsis/solicitation are due by May 23, 9:00 a.m. ET, emailed to Lisa.Schaupp@nih.gov.

The Government anticipates awarding a Firm Fixed Price contract with a twelve month base period, and four (4) twelve month option periods.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition

Circular (FAC) 2005-95, effective January 19, 2017.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 -

Electromedical and Electrotherapeutic Apparatus Manufacturing, with a small business size standard of 1250 employees.

The National Institute of Health, Clinical Center, Office of Purchasing and Contracts, is seeking a contractor who will provide a state of the art ultrasound machine, complete with warranty, and maintenance/service support for delivery to the Rehabilitation Medicine Department, NIH Clinical Center. Maintenance and Support shall include spare parts and supplies, emergency visits, hardware and software updates and support, hardware and software technology upgrades, as required by the Statement of Work. See Statement of Work attached herein.

Pricing Table. All businesses who are submitting an offer shall fill in the pricing table, below, with their firm fixed price.

Line

Item Estimated Period of Performance Qty U/I Total ($)

Base Period: Ultrasound Machine, including shipping and handling.

*Delivery by June 1, 2017, warranty through May 31, 2018

1 EA $_______

0002 Option Period One (1): June 1, 2018 – May 31, 2019 1 EA $_______

0003 Option Period Two (2): June 1, 2019 – May 31, 2020 1 EA $_______

0004 Option Period Three (3): June 1,2020 – May 31, 2021 1 EA $_______

0005 Option Period Four (4): June 1, 2021 – May 31, 2022 1 EA $_______

TOTAL Price If all Options are Exercised 4 EA $_______

*Contractor may propose a delivery schedule should June 1, 2017 not be possible.

STATEMENT OF WORK

Ultrasound machine

BACKGROUND:

The Functional & Applied Biomechanics (FAB) section in the Rehabilitation Medicine Department

(RMD) of the NIH Clinical Center uses a Philips IU22 ultrasound machine. This machine’s primary use is for clinical assessments including neurosurgical planning, ultrasound guided botulinum toxin injections, and ultrasound guided fine-wire EMG placement for research protocols. We are in need of immediate replacement of the current ultrasound machine in order to continue clinical assessments and research protocols.

mailto:Lisa.Schaupp@nih.gov

MINIMUM REQUIREMENTS / SPECIFICATIONS:

The ultrasound machine shall meet or exceed the technical specifications identified below. All items must be new. Used or remanufactured equipment will not be considered for award.

Functional Performance:

o We need a premium performance ultrasound machine to image musculoskeletal and peripheral nerve systems and make treatment/surgical decisions from these hi-resolution images.

Operational Performance:

o The following minimum specifications are required as stated in the Mandatory

Evaluation Criteria:

Transducers must be able to collect between the range of 3-18MHz (inclusive)

Machine capabilities:

Ability to collect 2D and 3D images, color and power wave Doppler, B-mode, M-mode, and shear wave

Extended field of view

Multiple pre-sets including MSK, Nerve, Gland (thyroid/breast)

Ability to collect shear wave elastography o Other evaluated features that are not required, but will be assigned points as stated in the Variable Evaluation Criteria:

Frame rate:

High frame rate exceeding 1000 frames/second for image acquisition – this is required for imaging and data collection for Doppler, during movement, and for shear wave imaging

Shear wave elastography

Multiple transducers able to collect shear wave

Must have at least one linear transducer (>12MHz) to collect shear wave, then an additional curvilinear transducer is acceptable; linear allows for higher frequency, which means better resolution than the curvilinear transducer

Real-time shear wave is preferred

Transducers:

At least one high frequency (collects up to 18MHz) linear transducer;

higher than 18MHz is preferred because high frequency is important for imaging peripheral nerves

At least one low frequency (collects down to 3 MHz) transducer – linear is preferred over a curvilinear transducer because the linear transducer provides superior imaging that is required for clinical and research imaging

Small footprint transducer (hockey stick) for imaging pediatric patients, small and irregular body parts

Larger footprint transducer (at least 50mm array)

Physical properties:

Display should move up/down and side to side for comfortable use both sitting and standing

At least 3 ports for ultrasound transducers

Needle visualization software

Smaller footprint of ultrasound machine is preferred

Export capabilities:

Ability to export the raw Radio Frequency (RF) B mode data

Ability to export raw beam form data in 2D or shear wave

Collaboration potential:

Having the same abilities in our machine as colleagues in the field increases our ability to collaborate on research projects.

DELIVERY TERMS:

System must be delivered fully assembled to:

NIH Clinical Center

9000 Rockville Pike

Bethesda, MD 20892

INSPECTION AND ACCEPTANCE:

Inspection and Acceptance will take place at the deliver to location.

NIH Clinical Center

9000 Rockville Pike

Bethesda, MD 20892

The Contracting Officer’s Representative (COR), to be determined at time of award, will inspect and accept goods and may perform operational tests to ensure the equipment performs in accordance with the original equipment manufacturer (OEM) specifications.

TRAINING:

One technician from the Contractor shall show 2-3 Government Employees how to use the machine once at time of delivery and acceptance.

WARRANTY:

Full system warranty for 12 months.

EXTENDED MAINTENANCE SERVICE:

Specifications:

Maintenance/repair will be performed in the Rehabilitation Medicine Department without patients present. The room will be determined upon scheduling a visit.

The vendor should be able to perform the on-site visit within one week of being contacted in order to prevent downtime.

Remote access to the ultrasound machine via software may not be possible due to

DCRI policy.

Labor, travel, and parts should be covered by the maintenance agreement.

Telephone technical support should be available during normal business hours.

Annual on-site maintenance should be covered.

PERIOD OF PERFORMANCE:

12 month base period with four (4) twelve month Option Periods for Warranty and

Maintenance Service.

Base Period: 6/1/2017 – 5/31/2018

Option Period One (1) (begins one year after date of acceptance date): 6/1/2018 –

5/31/2019

Option Period Two (2): 6/1/2019 – 5/31/2020

Option Period Three (3): 6/1/2020 – 5/31/2021

Option Period Four (4): 6/1/2021 – 5/31/2022

REGULATORY COMPLIANCE:

All contractor furnished products must be UL and C-UL classified, ISO (International

Organization for Standardization), and CE (European Conformity) compliant. They must meet all FDA clearances, and have received ADA acceptance.

Proposed medical devices/equipment must be in compliance with the FDA Good

Manufacturing Practices for medical devices and equipment. The equipment shall be in compliance with the FDA Safe Medical Devices Act, “Safety Medical Act of

1990” by Frank E. Samuel, Jr.

System components where required must possess 510K certifications and produced by a manufacturer with ISO 13485 Certification or equivalent. Contractor shall provide a copy of their certification with their offer.

510k Certification:

http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearanc es/510kclearances/default.htm and/or

ISO 13485 Certification:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm2

12795.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_ter m=ISO%2013485%20Certification&utm_content=1

End of Statement of Work

PROVISIONS AND CLAUSES

CLAUSES INCORPORATED BY REFERENCE

52.212-4 Contract Terms and Conditions--Commercial Items Jan 2017

CLAUSES INCORPORATED BY FULL TEXT

ADDENDUM TO 52.212-4

(v) The non-FAR Part 12 discretionary FAR, and LOCAL clauses included herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 for locations where full text can be found.

CLAUSES INCORPORATED BY REFERENCE

52.202-1 Definitions NOV 2013

52.203-3 Gratuities APR 1984

52.203-5 Covenant Against Contingent Fees MAY 2014

52.203-6 Restrictions On Subcontractor Sales To The Government (Sep

2006) Alternate 1

OCT 1995

http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/default.htm http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/default.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm212795.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=ISO%2013485%20Certification&utm_content=1 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm212795.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=ISO%2013485%20Certification&utm_content=1 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm212795.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=ISO%2013485%20Certification&utm_content=1

52.203-7 Anti-Kickback Procedures MAY 2014

52.203-8 Cancellation, Rescission, And Recovery Of Funds For Illegal Or

Improper Activity

MAY 2014

52.203-10 Price Or Fee Adjustment For Illegal Or Improper Activity MAY 2014

52.203-12 Limitation On Payments To Influence Certain Federal

Transactions

OCT 2010

52.203-17 Contractor Employee Whistleblower Rights And Requirement To

Inform Employees Of Whistleblower Rights

APR 2014

52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content

Paper

MAY 2011

52.204-9 Personal Identity Verification of Contractor Personnel JAN 2011

52.204-10 Reporting Executive Compensation and First-Tier Subcontract

Awards

OCT 2016

52.204-18 Commercial And Government Entity Code Maintenance JUL 2016

52.209-6 Protecting the Government's Interest When Subcontracting With

Contractors Debarred, Suspended, or Proposed for Debarment

OCT 2015

52.222-55 Establishing a Minimum Wage for Contractors (Deviation) DEC 2015

52.222-57 Representation Regarding Compliance with Labor Laws DEC 2016

52.222-59 Compliance with Labor laws (executive Order 13673) DEC 2016

52.222-60 Paycheck Transparency (Executive Order 13673) OCT 2016

52.223-5 Pollution Prevention and Right-to-Know Information MAY 2011

52.223-6 Drug Free Workplace MAY 2001

52.229-3 Federal State and Local Taxes FEB 2013

52.232-1 Payments APR 1984

52.232-17 Interest MAY 2014

52.232-18 Availability Of Funds APR 1984

52.232-23 Assignment of Claims MAY 2014

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013

52.233-3 Protest After Award AUG 1996

52.233-4 Applicable Law for Breach of Contract Claim OCT 2004

52.237-2 Protection Of Government Buildings, Equipment, And Vegetation APR 1984

52.237-3 Continuity of Services JAN 1991

52.242-13 Bankruptcy JUL 1995

52.242-15 Stop-Work Order AUG 1989

52.242-17 Government Delay Of Work APR 1984

52.245-1 Government Property JAN 2017

52.245-9 Use And Charges APR 2012

52.253-1 Computer Generated Forms JAN 1991

352.222-70 Contractor Cooperation in Equal Employment Opportunity

Investigations

DEC 2015

352.223-70 Safety and Health DEC 2015

352.227-70 Publications and Publicity DEC 2015

352.231-70 Salary Rate Limitation DEC 2015

352.237-74 Non-Discrimination in Service Delivery DEC 2015

52.217-8 -- Option to Extend Services. (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 calendar days.

(End of Clause)

52.217-9 -- Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor any time prior to the expiration of the contract; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 66 months.

(End of Clause)

52.222-40 Notification of Employee Rights Under the National Labor Relations Act (DEC 2010)

(a) During the term of this contract, the Contractor shall post an employee notice, of such size and in such form, and containing such content as prescribed by the Secretary of Labor, in conspicuous places in and about its plants and offices where employees covered by the National Labor Relations Act engage in activities relating to the performance of the contract, including all places where notices to employees are customarily posted both physically and electronically, in the languages employees speak, in accordance with 29 CFR

471.2(d) and (f).

(1) Physical posting of the employee notice shall be in conspicuous places in and about the Contractor's plants and offices so that the notice is prominent and readily seen by employees who are covered by the

National Labor Relations Act and engage in activities related to the performance of the contract.

(2) If the Contractor customarily posts notices to employees electronically, then the Contractor shall also post the required notice electronically by displaying prominently, on any Web site that is maintained by the Contractor and is customarily used for notices to employees about terms and conditions of employment, a link to the Department of Labor's Web site that contains the full text of the poster. The link to the Department's Web site, as referenced in (b)(3) of this section, must read, ``Important Notice about Employee Rights to Organize and Bargain Collectively with Their Employers.''

(b) This required employee notice, printed by the Department of Labor, may be--

(1) Obtained from the Division of Interpretations and Standards, Office of Labor-Management Standards, U.S. Department of Labor, 200 Constitution Avenue, NW., Room N-5609, Washington, DC 20210, (202)

693-0123, or from any field office of the Office of Labor-Management Standards or Office of Federal

Contract Compliance Programs;

(2) Provided by the Federal contracting agency if requested;

(3) Downloaded from the Office of Labor-Management Standards Web site at http://www.dol.gov/olms/regs/compliance/EO13496.htm; or

(4) Reproduced and used as exact duplicate copies of the Department of Labor's official poster.

(c) The required text of the employee notice referred to in this clause is located at Appendix A, Subpart

A, 29 CFR Part 471.

(d) The Contractor shall comply with all provisions of the employee notice and related rules, regulations, and orders of the Secretary of Labor.

(e) In the event that the Contractor does not comply with the requirements set forth in paragraphs (a) through (d) of this clause, this contract may be terminated or suspended in whole or in part, and the

Contractor may be suspended or debarred in accordance with 29 CFR 471.14 and subpart 9.4. Such other sanctions or remedies may be imposed as are provided by 29 CFR part 471, which implements Executive

Order 13496 or as otherwise provided by law.

(f) Subcontracts. (1) The Contractor shall include the substance of this clause, including this paragraph

(f), in every subcontract that exceeds $10,000 and will be performed wholly or partially in the United

States, unless exempted by the rules, regulations, or orders of the Secretary of Labor issued pursuant to section 3 of Executive Order 13496 of January 30, 2009, so that such provisions will be binding upon each subcontractor.

(2) The Contractor shall not procure supplies or services in a way designed to avoid the applicability of

Executive Order 13496 or this clause.

(3) The Contractor shall take such action with respect to any such subcontract as may be directed by the

Secretary of Labor as a means of enforcing such provisions, including the imposition of sanctions for noncompliance.

(4) However, if the Contractor becomes involved in litigation with a subcontractor, or is threatened with such involvement, as a result of such direction, the Contractor may request the United States, through the

Secretary of Labor, to enter into such litigation to protect the interests of the United States.

(End of clause)

52.232-25 -- Prompt Payment (Jul 2013)

(a) Invoice payments—

(5) Computing penalty amount. The Government will compute the interest penalty in accordance with the Office of Management and Budget prompt payment regulations at 5 CFR part 1315.

(i) For the sole purpose of computing an interest penalty that might be due the Contractor, Government acceptance is deemed to occur constructively on the 15th day (unless otherwise specified in this contract) after the Contractor delivers the supplies or performs the services in accordance with the terms and conditions of the contract, unless there is a disagreement over quantity, quality, or Contractor compliance with a contract provision.

If actual acceptance occurs within the constructive acceptance period, the Government will base the determination of an interest penalty on the actual date of acceptance. The constructive acceptance requirement does not, however, compel Government officials to accept supplies or services, perform contract administration functions, or make payment prior to fulfilling their responsibilities.

52.252-2 -- Clauses Incorporated By Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

Regulations URLs: (Click on the appropriate regulation.)

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm

NOTE: After selecting the appropriate regulation above, at the "Table of Contents" page, conduct a search for the desired regulation reference using your browser's FIND function. When located, click on the regulation reference (hyperlink).

52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984)

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.

(b) The use in this solicitation or contract of any HHSAR FAR Supplement (48 CFR Chapter 3) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

(End of clause)

INVOICE REQUIREMENTS

In addition to the requirements in attachment titled “Invoice and Payment Provisions (2/2014)”, the following information must be stated on the invoice.

1) List name of employee performing maintenance

2) Dates worked

3) Total for entire invoice

A. The contractor shall submit the original and a copy of the invoices concurrently as follows:

a. An original mailed to the following designated payment office:

National Institutes of Health

Office of Financial Management

Commercial Accounts, Room 4B-432

2115 East Jefferson Street MSC 8500

Bethesda, Maryland 20892-8500

b. One copy e-mailed to the Contracting Officer’s Representative at:

National Institutes of Health

PET Department

Bethesda, Maryland 20892

Email: (to be determined)

(End of Addendum to 52.212-4)

PROVISIONS INCORPORATED BY REFERENCE

INSTRUCTIONS TO OFFERORS:

Addendum to FAR 52.212-1, Acceptance of Terms and Conditions

This is a Sole-Source Combined Synopsis/Solicitation for maintenance of equipment as defined herein.

Offers will be reviewed exclusively based upon information submitted. If the information submitted does

52.212-1 Instructions to Offerors--Commercial Items JAN 2017 not address all the technical characteristics required in this combined solicitation-synopsis, the offer will be rejected. The Government intends to award a Fixed Price Contract as a result of this Combined

Synopsis/Solicitation that will include the terms and conditions that are set forth herein. In order to facilitate the award process, ALL offers shall include a statement regarding the terms and conditions herein as follows:

The offeror shall state “The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition.”

OR

The offeror shall state “The terms and conditions in the solicitation are acceptable to be included

In the award document with the exception, deletion, or addition of the following:

Offeror shall list exception(s) and rationale for the exception(s)

Please note that this procurement is not being conducted under the GSA Federal Supply Schedule (FSS) program or another Government-Wide Area Contract (GWAC). If an offeror submits an offer based upon an FSS or GWAC contract, the Government will accept the quoted price. However, the terms and conditions stated herein will be included in any resultant Contract, not the terms and conditions of the offeror’s FSS or GWAC contract, and the statement required above shall be included in the offer.

(End of Addendum to FAR 52.212-1)

Addendum to FAR 52.212-1, Proposal Preparation Instructions

FAR 52.212-1 is hereby amended to reflect the changes shown below as to the specific paragraph revised.

Paragraph (b) Submission of Offers. The following amends this paragraph with respect to the information and documents required for submission in response to this solicitation.

(1) ELECTRONIC OFFERS. The offeror shall submit electronic offers in response to this solicitation unless otherwise specified herein. The offer must arrive by the time specified in the solicitation to the following email address: Lisa.Schaupp@nih.gov .

(2) PROCESS FOR AWARD. Award will be made to the Best Value Offeror consistent with the evaluation criteria discussed at FAR 52.212-2 and Addendum to FAR 52.212-2.

(3) BASIS FOR AWARD. Award will be made to the offeror that proposes: a technical proposal conforming to the requirements of the solicitation; has an acceptable record of past performance; its price is determined to be fair and reasonable by the contracting officer; and the contracting officer determines the offeror is responsible in accordance with FAR Part 9. The Contracting Officer intends to award without discussions, but reserves the right to do so in his or her sole discretion.

(4) The Government may reject a proposal if it is found that any information that has a negative impact on the offeror's past performance record has been deleted, misrepresented, or withheld.

(5) Offers shall remain valid for a period of 90 days from the date offers are due.

(6) Quotation shall include Certifications and Representations, Technical, Past Performance, and Price as separate parts in the submission.

mailto:Lisa.Schaupp@nih.gov

CERTIFICATIONS & REPRESENTATIONS:

Provide pricing for each Contract Line Item Numbers (CLINS).

Verification of current account in the System for Award Management

QUOTATION COMPOSITION:

PART I: TECHNICAL

TECHNICAL CAPABILITY - The offeror shall provide sufficient information to demonstrate its understanding of the requirements, providing a concise, detailed, and thorough discussion of its technical capability to successfully provide the supplies and services as required in this solicitation.

Submissions shall meet at least, the criteria described in the Statement Work above.

PART II: PAST PERFORMANCE.

Offerors shall submit past performance information on at least two (2) but not more than four (4) recent and relevant contracts (within the past three years from the date of the solicitation). If more than four contract references are submitted, only the first four will be evaluated. References may include performance on contracts for Federal, State and local Governments as well as private commercial firms of similar size and scope.

Section 1 – Contract Description Information:

Offeror’s CAGE Code and DUNS Number. Point of Contact (POC) (name, and current address, e-mail address, and telephone and fax numbers). Contracting activity/Administration and current address, Contracting Officer or Technical Representative Name, e-mail address, telephone and fax numbers.

Contract Number and, in the case of Indefinite Delivery type contracts, GSA contracts, and Blanket

Purchase Agreements, include Delivery Order Numbers also; Awarded price; Final or projected final price; Original/Final delivery schedule, including dates of start and completion of delivery.

Section 2 – Performance (See FAR Provision 52.212-2 Addendum Government intends to evaluate.)

Offerors shall provide a specific narrative explanation of each contract listed in Section 1 above describing recency and relevancy of the requirements in this solicitation.

For any contracts that did not/do not meet original schedule or technical performance requirements, provide a brief explanation of the reason(s) for the shortcomings and any corrective action(s) taken to avoid recurrence. The Offerors shall indicate if any of the contracts listed were terminated and the type and reasons for the termination.

PART III: PRICE.

Offerors shall provide pricing for all item/s specified on each Contract Line Item Number (CLIN) of the solicitation.

Addendum to FAR 52.212-1, Proposal Preparation Instructions Continued

Para (g) Contract award. This paragraph is amended to state that the Government may conduct discussions prior to contract award.

Para (j) Data Universal Numbering System (DUNS)/CAGE Code. This paragraph is amended to state that the offeror shall obtain these Codes and include them in the proposal and confirm Registration in

System for Award Management and the Online Representations and Certifications, if you are a US firm.

Award cannot and shall not be made to an offeror without these codes.

Para (m) Proposal Preparation Costs. This solicitation does not commit the Government to pay any costs incurred in the submission of an offer, in making any necessary studies for the preparation thereof, or for any visit(s) the Contracting Officer may request for the purpose of clarification of the offer.

Para (n) The offeror is responsible for ensuring that its proposal is complete. The proposal shall be clear, concise, and shall include sufficient detail for effective evaluation and for substantiating the validity of any stated claims. The proposal shall not simply rephrase or restate the Government's requirements, but rather shall provide convincing rationale to address how the offeror intends to perform the requirement.

The offeror shall assume that the Government has no prior knowledge of their experience and will base its evaluation solely on the information presented in the offeror's proposal.

Para (o) Protests received at a level higher than the contracting officer will be referred to the contracting officer. Protestor may request a review by the contracting officer or an independent review at a level higher than the contracting officer. Requests for appeals or independent review will be addressed to the contracting officer for referral to the review authority. Questions on this process will be referred to the cognizant contracting officer identified in the solicitation.

Para (p) The non-FAR Part 12 discretionary FAR, and LOCAL provisions included herein are incorporated into this solicitation either by reference or in full text. If incorporated by reference, see provision 52.252-1 herein for locations where full text can be found.

(End of Addendum to FAR 52.212-1)

52.212-2 EVALUATION--COMMERCIAL ITEMS (JAN 1999)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: See Addendum to 52.212-2

(b) 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).

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

(End of provision)

ADDENDUM TO 52.212-2

Paragraph (a) is hereby supplemented with the following:

The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered.

Award will be made using the best value source selection process.

Except for communications conducted for the purpose of minor clarification, the Government intends to evaluate the proposal and award a contract without discussions.

In the evaluation of all Offerors’ proposals, appropriate consideration is given to three (3) evaluation factors:

Technical, Past Performance and Price are in descending order of importance. Technical is more important than past performance. Technical and Past Performance, when combined, are significantly more important than Price. The importance of price in the evaluation will increase with the degree of equality among quotations of the non-price factors.

To receive consideration for award, all Mandatory Criteria must be passed, and a score of at least 144 points or 80% of the possible points available in the Variable Criteria must be achieved for the technical capability evaluation factor. For Past Performance, the offeror must receive a rating of no less than an overall “satisfactory confidence” in the Performance Ratings in the Government Reporting system, “PPIRS” to be considered for award. However, proposals receiving an unknown (neutral) past performance rating will be considered for award.

EVALUATION FACTORS -- THE FOLLOWING FACTORS WILL BE EVALUATED:

PART I: TECHNICAL

In order for a quotation to receive full consideration and be eligible for award, the following mandatory requirements must be fully met at the time of the receipt of quotation. Mandatory requirements shall be evaluated on a PASS/FAIL basis.

Mandatory Criteria

1. Transducers collect between 3-18MHz (inclusive)………………………Pass/Fail

2. Machine capabilities: 2D and 3D images, color and power wave Doppler, B mode, M mode, and shear wave, extended field of view, multiple pre-sets………..Pass/Fail

3. Ability to collect shear wave elastography……………………………….Pass/Fail

In determining the best overall applicant, the following criteria will be scored with the maximum point values for each area, yielding a total of 180 obtainable points.

Additional Criteria (total points = 180)

1. Frame rate: above 1000 frames/second preferred………………………… (20 points)

2. Shear wave elastography: linear transducers, multiple transducers, and real-time

……………………………………………………………………………..(40 points)

3. Transducers: >18MHz, linear down to 3MHz, hockey stick transducer, at least 50mm array transducer ……………………………………………………………(60 points)

4. Physical properties: adjustable display, at least 3 transducer ports, footprint of ultrasound machine, needle visualization software ……………………………………..(20 points)

5. Export capabilities: RF B mode data, beam form data in 2D and shear wave (20 points)

6. Collaboration potential……………………………………………………… (20 points)

a. Same machine as colleagues in our field increases our ability to collaborate on research projects

The Government reserves the right to reject any or all proposals received. It is understood that your proposal will become part of the official file on this matter without obligation to the

Government.

The total evaluation point schema has a maximum of 180 points and is broken down as follows:

Frame rate 20 points

Shear wave elastography 40 points

Transducers 60 points

Physical properties 20 points

Export capabilities 20 points

Collaboration potential 20 points

TOTAL (Maximum Point Score) = 180 points

PART II: PAST PERFORMANCE

The past performance evaluation results is an assessment of the offeror’s probability of meeting the minimum past performance solicitation requirements. This assessment is based on the offeror’s record of relevant and recent past performance information that pertain to the products and/or services outlined in the solicitation requirements.

Offerors are cautioned that in conducting present and past performance evaluations, the Government may use data provided in the offeror's proposal, any other source available to the Government and data obtained from other sources to include, but not limited, to data independently obtained from other

Government and commercial sources.

After the Government has evaluated Offerors’ past performance for recency and relevancy, the

Government will evaluate Quality of Performance (how well the contractor has performed on contracts).

The Government will assign an Unknown /Neutral rating, meaning the rating is treated neither favorably nor unfavorably, to Offerors with no recent/relevant past performance record or the offeror’s performance record is not available or the information is inadequate such that no meaningful confidence assessment rating can be reasonably assigned.

6. Contractor Past Performance submission criteria

a. Include the following information for each contract or subcontract:

Name of contracting organization

Contact number (for subcontracts, provide the prime contact number and the subcontract number)

Contract type

Total contract value

Description of requirement

Contracting Officer’s name and telephone number

Program Manager’s name and telephone number

b. Each offeror will be evaluated on its past performance under existing and prior contracts for similar products and services. Performance information will be used for both responsibility determinations and as an evaluation factor against which offeror’s relative rankings will be compared to assure the best value to the Government. The Government will focus on information that demonstrates quality of performance relative to the size and complexity of the acquisition under consideration.

c. The Government is not required to contact all references by the offeror. Also, references other than those identified by the offeror may be contacted by the Government to obtain additional information that will be used in the evaluation of the offeror’s past performance.

Note: In the case of an offeror without a record of relevant past performance or for whom information on past performance is not available or so sparse that no meaningful past performance rating can be reasonably assigned, the offeror may not be evaluated favorably or unfavorably on past performance (see

FAR 15.305 (a)(2)(iv)). Therefore, the offeror shall be determined to have “unknown” past performance and their performance confidence assessment rating will be “unknown confidence (neutral).”

PART III: PRICE

Price will be evaluated separately from the technical and past performance factors and will be evaluated for fairness and reasonability in terms of the Government’s requirement.

(End of Addendum)

52.212-3 -- Offeror Representations and Certifications -- Commercial Items.

As prescribed in 12.301(b)(2), insert the following provision:

Offeror Representations and Certifications -- Commercial Items (Jan 2017)

The offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management

(SAM) Web site located at http://www.sam.gov/portal. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (u) of this provision.

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

“Administrative merits determination” means certain notices or findings of labor law violations issued by an enforcement agency following an investigation. An administrative merits determination may be final or be subject to appeal or further review. To determine whether a particular notice or finding is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance.

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/12.htm#P120_20016 http://www.sam.gov/portal

“Arbitral award or decision” means an arbitrator or arbitral panel determination that a labor law violation occurred, or that enjoined or restrained a violation of labor law. It includes an award or decision that is not final or is subject to being confirmed, modified, or vacated by a court, and includes an award or decision resulting from private or confidential proceedings. To determine whether a particular award or decision is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance.

“Civil judgment” means--

(1) In paragraph (h) of this provision: A judgment or finding of a civil offense by any court of competent jurisdiction.

(2) In paragraph (s) of this provision: Any judgment or order entered by any Federal or

State court in which the court determined that a labor law violation occurred, or enjoined or restrained a violation of labor law. It includes a judgment or order that is not final or is subject to appeal. To determine whether a particular judgment or order is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance.

“DOL Guidance” means the Department of Labor (DOL) Guidance entitled: “Guidance for

Executive Order 13673, ‘Fair Pay and Safe Workplaces’ “. The DOL Guidance, dated August

25, 2016, can be obtained from www.dol.gov/fairpayandsafeworkplaces.

“Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13

CFR part 127. It automatically qualifies as a women-owned small business eligible under the

WOSB Program.

“Enforcement agency” means any agency granted authority to enforce the Federal labor laws. It includes the enforcement components of DOL (Wage and Hour Division, Office of Federal

Contract Compliance Programs, and Occupational Safety and Health Administration), the Equal

Employment Opportunity Commission, the Occupational Safety and Health Review

Commission, and the National Labor Relations Board. It also means a State agency designated to administer an OSHA-approved State Plan, but only to the extent that the State agency is acting in its capacity as administrator of such plan. It does not include other Federal agencies which, in their capacity as contracting agencies, conduct investigations of potential labor law violations.

The enforcement agencies associated with each labor law under E.O. 13673 are--

(1) Department of Labor Wage and Hour Division (WHD) for--

(i) The Fair Labor Standards Act;

(ii) The Migrant and Seasonal Agricultural Worker Protection Act;

(iii) 40 U.S.C. chapter 31, subchapter IV, formerly known as the Davis-Bacon

Act;

(v) 41 U.S.C. chapter 67, formerly known as the Service Contract Act;

(vi) The Family and Medical Leave Act; and http://www.dol.gov/fairpayandsafeworkplaces

(vii) E.O. 13658 of February 12, 2014 (Establishing a Minimum Wage for

Contractors);

(2) Department of Labor Occupational Safety and Health Administration (OSHA) for--

(i) The Occupational Safety and Health Act of 1970; and

(ii) OSHA-approved State Plans;

(4) Department of Labor Office of Federal Contract Compliance Programs (OFCCP) for-

(i) Section 503 of the Rehabilitation Act of 1973;

(ii) The Vietnam Era Veterans' Readjustment Assistance Act of 1972 and the

Vietnam Era Veterans' Readjustment Assistance Act of 1974; and

(iii) E.O. 11246 of September 24, 1965 (Equal Employment Opportunity);

(5) National Labor Relations Board (NLRB) for the National Labor Relations Act; and

(6) Equal Employment Opportunity Commission (EEOC) for--

(i) Title VII of the Civil Rights Act of 1964;

(ii) The Americans with Disabilities Act of 1990;

(iii) The Age Discrimination in Employment Act of 1967; and

(iv) Section 6(d) of the Fair Labor Standards Act (Equal Pay Act).

“Forced or indentured child labor” means all work or service—

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

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

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

“Immediate owner” means an entity, other than the offeror, that has direct control of the offeror.

Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

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

“Labor compliance agreement” means an agreement entered into between a contractor or subcontractor and an enforcement agency to address appropriate remedial measures, compliance assistance, steps to resolve issues to increase compliance with the labor laws, or other related matters.

“Labor laws” means the following labor laws and E.O.s:

(1) The Fair Labor Standards Act.

(2) The Occupational Safety and Health Act (OSHA) of 1970.

(3) The Migrant and Seasonal Agricultural Worker Protection Act.

(4) The National Labor Relations Act.

(5) 40 U.S.C. chapter 31, subchapter IV, formerly known as the Davis-Bacon Act.

(6) 41 U.S.C. chapter 67, formerly known as the Service Contract Act.

(7) E.O. 11246 of September 24, 1965 (Equal Employment Opportunity).

(8) Section 503 of the Rehabilitation Act of 1973.

(9) The Vietnam Era Veterans' Readjustment Assistance Act of 1972 and the Vietnam

Era Veterans' Readjustment Assistance Act of 1974.

(10) The Family and Medical Leave Act.

(11) Title VII of the Civil Rights Act of 1964.

(12) The Americans with Disabilities Act of 1990.

(13) The Age Discrimination in Employment Act of 1967.

(14) E.O. 13658 of February 12, 2014 (Establishing a Minimum Wage for Contractors).

(15) Equivalent State laws as defined in the DOL Guidance. (The only equivalent State laws implemented in the FAR are OSHA-approved State Plans, which can be found at www.osha.gov/dcsp/osp/approved_state_plans.html).

“Labor law decision” means an administrative merits determination, arbitral award or decision, or civil judgment, which resulted from a violation of one or more of the laws listed in the definition of “labor laws”.

“Manufactured end product” means any end product in product and service codes (PSCs) 1000-

9999, except—

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

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

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

“Place of manufacture” means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

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

“Restricted business operations” means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets

Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

http://www.osha.gov/dcsp/osp/approved_state_plans.html

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended.

Sensitive technology—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the

President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

“Service-disabled veteran-owned small business concern”—

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

“Small business concern” means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and size standards in this solicitation.

“Small disadvantaged business concern, consistent with 13 CFR 124.1002,” means a small business concern under the size standard applicable to the acquisition, that--

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR

124.105) by--

(i) One or more socially disadvantaged (as defined at 13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at

13 CFR 124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at

13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

“Subsidiary” means an entity in which more than 50 percent of the entity is owned—

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

“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.

“Veteran-owned small business concern” means a small business concern—

(1) Not less than 51 percent of which is owned by one or more veterans(as defined at 38

U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The…