36C25726Q0671_2.docx

SUBJECT*

Compact B-Scan Imaging Ultrasound System

GENERAL INFORMATION

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs Network Contracting Office 17 5441 Babcock Road Ste. 302 San Antonio TX 78240

POINT OF CONTACT*

Contracting Officer Rafael Rodriguez Rafael.Rodriguez2@va.gov

PLACE OF PERFORMANCE

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

See Continuation Page.

Amendment to a Previous Combined Solicitation

Amendment to a Previous Combined Solicitation

Page 1 of

Amendment to a Previous Combined Solicitation

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

07-01-2026

None

Department of Veterans Affairs Network Contracting Office 17 5441 Babcock Road Ste. 302 San Antonio TX 78240

Same as Block 6

To all Offerors/Bidders

36C25726Q0671

X

Title: Compact B-Scan Imaging Ultrasound System

1. The purpose of this amendment is to submit answers to questions submitted by Vendors.

2. A revised SOW is added to indicate Brand Name or Equal.

// See Continuation Page//

Rafael Rodriguez Contracting Officer

Questions and answers:

1. Brand-name-or-equal / salient characteristics. Several specifications in the Statement of Work — including the named keratometric and IOL calculation methods (e.g., Rosa regression, Shammas regression, and Double-K/SRK-T per Aramberri), the pseudophakic material pattern recognition (PMMA, acrylic, and silicone), and automatic scleral-spike detection — correspond closely to the published feature set of a single original equipment manufacturer. Will the Government accept a domestically manufactured, small-business system that meets the functional and clinical intent of these requirements (diagnostic B-scan imaging; A-scan biometry with post-refractive IOL calculation; DICOM connectivity) using equivalent calculation methods that may be named differently? In other words, is this requirement intended as brand-name-or-equal? Changes were made to the SOW specifying that it is Brand name or Equal. Refer to below SOW.

2. IOL / keratometric methods. Are the six specifically named calculation methods mandatory by name, or will equivalent formulas performing the same clinical functions be considered technically acceptable? Equivalent formulas performing the same clinic function will be acceptable

3. B-scan probe frequency. Is a probe operating at exactly 15 MHz required, or is a probe operating at approximately 15 MHz (for example, a dual 12.5/15 MHz transducer) acceptable? A dual transducer is acceptable so long as it performs at the level requested (15 MHz)

4. Country of origin vs. feature set. The solicitation restricts award to U.S. end items only and incorporates the Buy American Certificate (FAR 52.225-2). Please confirm that, in the event of any conflict, the domestic end-item requirement governs and that a product not manufactured in the United States cannot be considered regardless of feature alignment.

Only American Made products will be accepted

5. Nonmanufacturer rule. As a 100% small business set-aside under NAICS 339115, please confirm whether the end item must be manufactured by a small business concern in the United States, or whether an SBA class or individual waiver applies to this acquisition (NAICS 339115 / PSC 6525). It can be manufactured by a Large Business

6. Installation, testing, and training. Please confirm whether installation, system testing, biomedical safety documentation, and clinical training may be performed by a manufacturer-authorized service provider, and confirm the required completion timeline. Yes, installation, system testing, biomedical safety documentation, and clinical training may be performed by a manufacturer-authorized service provider within the required timeline.

Statement of Work General: Compact B-Scan Imaging Ultrasound System Description of Work: This statement of work defines the effort required for VA Texas Valley Coastal Bend Healthcare System (VATVCBHCS), Optometry Section of Surgical Service to procure a B-Scan Imaging Ultrasound System at one (1) location. The Optometry Department in Harlingen is requesting a new Compact B-Scan Imaging Ultrasound System to facilitate the increased demand for patient optical care. The proposed B-Scan Imaging Ultrasound System will allow the doctor to diagnose retinal detachments, tumors, and citreous pathologies.

Place of Delivery - The vendor shall deliver the described herein to:

VATVCBHCS

VA Harlingen Healthcare Center (HCC) Receiving Dock 2601 Veterans Drive Harlingen, TX 78550

System Requirements and Specifications for Compact B-Scan Ultrasound System (Brand name or Equal)

· Must be or equal to lightweight and easily transportable and cart-based unit suitable for small examination rooms.

· Must have an integrated color high-resolution touchscreen with integrated DICOM connectivity or equal to.

· Must be DICOM compatible, and must support DICOM storage, worklist, and print functionalities to interface with VA Systems.

· Must have USB ports for data export, ethernet port, and HDMI output or equal to.

· Must have B-Scan Transducer frequency of 15 MHz or equal to.

· Must have built-in pattern recognitions phakic, aphakic, PMMA, acrylic, and silicone material for pseudo-phakic eye types or equal to.

· Must have automatic detection of scleral spike or equal to.

· Must have at least six (6) different methods for keratometric correction and implant calculation: History derived, refraction derived, contact lens method, Rosa regression, Shammas regression, Double K/SRK-T (Dr. Aramberri’s formula) or equal to.

· Must have the ability to display at least four (4) different IOL calculations or equal to.

· Contractor or manufacturer-authorized service provider is responsible for installation and configuration of the newly provided Compact B-Scan Ultrasound System.

· Contractor or manufacturer-authorized service provider is responsible for comprehensive system testing for the newly provided Compact B-Scan Ultrasound System. Testing documentation shall be provided to VATVCBHCS Biomedical Engineering prior to acceptance of equipment. Contractor shall be able to certify the newly provided Compact B-Scan Ultrasound System is safe and ready for use on patients.

· Delivery of all hardware should be completed within 90 days from date of award. Implementation of all hardware should be completed within 60 days after hardware delivery. Education and training may take 60 – 90 days after hardware implementation.

· Compact B-Scan Ultrasound System must include at least a one-year warranty.

Brand Name or Equal To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must-

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by-

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.

The Contracting Officer will evaluate "equal" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation.

Documentation: Contractor shall furnish a delivery manifest once all equipment has been delivered. Payment will not be processed until all equipment has been received by Surgery Service. Payment will not be processed until a properly completed service report is received. The service report shall contain, at a minimum, the following information:

· Date and time of contractor’s arrival on station

· Complete list of instruments and consumable delivered/required

The service report shall itemize every item in the specification. Each item shall state a complete description of all work performed concerning the items.

Information Systems Officer, Information Protection: The contractor will/will not have access to VA Desktop computers nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

Privacy Officer: The contractor will/will not have access to protected Patient Health Information (PHI) nor will they have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified.

Records Manager: The NARA Records Management language (Attached) only need to be added if records could be created, maintained or dispositioned by the contract/contractor. Otherwise, this “no records” statement can be used: Records Officer: There will be no federal records created, maintained, used or dispositioned with this contract; regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.]. So short version for no records – long version for records will be created, maintained, etc.

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. VATVCBHCS and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VATVCBHCS or destroyed except for in accordance with the provisions of the agency records schedule and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VATVCBHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment are properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment are no longer required, it shall be returned to VATVCBHCS control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VATVCBHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VATVCBHCS policy.

8. The Contractor shall not create or maintain any records containing any non-public VATVCBHCS information that is not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. VATVCBHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VATVCBHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.