Effective Date: 04/18/2025 Revision: 02 Description This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-04. This solicitation is set-aside for: Small Business The associated North American Industrial Classification System (NAICS) code for this procurement is 339112, with a small business size standard of 1,000 Employees. The FSC/PSC is 6515 The Veterans Health Administration, Regional Procurement Office East, Network Contracting Office 1 is seeking to purchase Brand Name Medtronics PTeye Parathyroid Detection System Basic Bundle. All interested companies shall provide quotations for the following: Line Item Description Quantity Unit of Measure Unit Price Total Price 0001 Medtronics PTeye Parathyroid Detection System Basic Bundle (PT102) 1 EA Providence VA Medical Center Medtronic PTeye Parathyroid detection system Performance Work Statement Objective The purpose of this Performance Work Statement (PWS) is to outline the tasks and responsibilities of the awarded Contractor in relation to the provision, installation, and implementation of the Medtronic PTeye Parathyroid detection system. This document highlights the technical specifications and services being requested by the Providence VAMC for consideration towards the purchase of Parathyroid detection system. Vendors under this proposal shall provide all equipment, accessories, applicable training, and manuals. Project Management/Equipment Implementation Product delivery will be the responsibility of the Vendors working with the Providence VAMC project management POC, the Vendor will be responsible for coordinating and performing the delivery, implementation, and training for the devices. Project Management POC Name: Dylan Saraiva Section: TCF Biomedical Engineer Address: 830 Chalkstone Avenue Providence, RI 02908 Phone Number: Phone: (401) 273-7100 Ext. 13187 E-Mail Address: dylan.saraiva@va.gov Background The Medtronic PTeye Parathyroid detection system is an intraoperative probe-based near-infrared autofluorescence (NIRAF) detection system. Primarily used in the operating room, the Medtronic PTeye Parathyroid detection system works by emitting light at wavelengths suitable for stimulating native fluorescence in biological tissues from a small probe. Parathyroid glands, due to their biochemical composition, emit a distinct autofluorescence when illuminated by this light emitting probe. The system then captures and analyzes the emitted fluorescence in real-time, allowing physicians to detect parathyroid tissue quickly and accurately during surgical procedures. Therefore, the Medtronic PTeye Parathyroid detection system helps physicians differentiate between parathyroid glands and other tissues, reducing surgical errors by confirming the tissues targeted for removal and protecting healthy parathyroid tissues. This aids in preventing the complication of permanent hypoparathyroidism, which leads to hypocalcemia. This problem causes long-term complications related to bone and kidney health and is hard to manage on a day-to-day basis. For this reason, it can lead to life-threatening heart arrhythmias due to fluctuations in calcium levels in the blood. In a sensitive patient population, such as Veterans, preserving parathyroid tissues and their functions is essential to patient health and well-being. This technology and its capabilities are limited to Medtronic, as it is the first and only dye-free parathyroid detection system on the market. The facility s primary goals are to maintain high quality care, standardize and improve safety, more effective and efficient use of staff and overall improvement in patient care. By procuring the Medtronic PTeye Parathyroid detection system, a device that is proven to decrease surgical error and increase accuracy, clinical care can be improved. Equipment Specifications Equipment: All equipment must be new, state of the art, and not recertified nor refurbished. All equipment must be compliant with current VA requirements including vendor supported operating systems. Vendor must support equipment for 10 years from point of purchase. System Equipment Set-up and configuration of the equipment including assembly, software configuration, calibration, and user management. Other (2) User Manuals (2) Service Manuals (2) Cleaning instructions Information on disposable procurement Services Training Installation Training Provided/Training Materials Vendor will be required to provide two user manuals for the Medtronic PTeye Parathyroid detection system. Vendor will be required to provide two service manuals for the Medtronic PTeye Parathyroid detection system. Vendor will be required to provide an on-station in-service on the proper use and setup of the system. Vendor will be required to provide the cleaning methods/guidelines Medtronic PTeye Parathyroid detection system and all accessories. All employees who will be utilizing the table, including Providers, Technicians, Biomedical Engineering, and Clinic staff members ("Trainees"), must be trained by an authorized representative by Medtronic prior to using the System. No charge on a mutually agreeable date and time. Installation Contractor s Responsibilities: Based on approved deployment work schedule, the Contractor shall provide all labor necessary to install, deploy and configure the requirements of Providence VAMC. Contractor shall receive and place equipment in the pre-arranged designated areas at the Providence VAMC. The Contractor shall unpack and install all equipment in the designated area and dispose of all trash. Disposing of the trash is the responsibility of the Contractor. Contractor shall perform all installation and configuration necessary to complete the work, plus perform technical service checks to ensure product is fully operational in accordance with manufacture operating standards. Vendor will coordinate all site visits with the staff at least 24 hours in advance. The vendor will provide all technical and clinical information needed to configure the software. The vendor will provide at-least a 1-year manufacturer warranty on the device from the date of installation. Medical Center s Responsibilities: Providing access to patient care spaces, hallways, and equipment rooms during normal business hours for implementation of the general system installation requirements. Providing a single point of contact to work with in planning and implementing the services described. Assign additional clinical staff during the transitions. Provide staff and clinical resources during go-live Responsible for any structural changes (cabinets, desks, etc.). On-site assembly and installation of items and performance of services identified in this document will take place during hours defined as: 0730 to 1500 (i.e.: 7:30 am to 3:00 pm ET), Saturday or Sunday, excluding Federal Holidays High risk clinical areas may require after hours install. The Contractor is required to provide all tools, labor, and materials to complete assembly and installation of the items detailed in this document. The Contractor shall have an on-site representative for the duration of assembly and installation to serve as the primary interface with the Providence VAMC staff. The Providence VA will provide a staging area for the equipment to be staged before deployed. Security Requirements Vendor will not have access to VA Sensitive Information, patient records, or data. For repairs or services performed during normal work hours, 7:00 a.m. to 4:00 p.m. at the Providence VA Medical Center, contractor s repairman shall report to the Security Office located at the entrance of the Medical Center. Contractors shall sign-in and obtain a badge and return the badge at the end of the day. After all work is complete, the contractor s repairman shall again report in person to the room listed above, submit a written service report outlining the services performed and completed to include location and parts used. For services performed outside normal working hours, the contractor s repairman should report to the Security Office at Providence VA Medical Center. After all work is complete the contractor s repairman shall again report to the Security Office where the repairman shall submit the report required above. The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract: Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. 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 by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. 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, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. Place of Performance Providence VA Medical Center 830 Chalkstone Avenue Providence, Rhode Island 02908 The full text of FAR provisions or clauses may be accessed electronically at https://www.acquisition.gov/browse/index/far. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Products and Commercial Services FAR 52.212-3, Offerors Representations and Certifications Commercial Products and Commercial Services (MAY 2024) (DEVIATION FEB 2025) Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://sam.gov/ in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Products and Commercial Services. If paragraph (j) of the provision is applicable, a written submission is required. FAR 52.212-2 Evaluation-Commercial Products and Commercial Services The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Products and Commercial Services (Nov 2023) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products and Commercial Services (Jan 2025) [(DEVIATION FEB 2025)] The following subparagraphs of FAR 52.212-5 are applicable: 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) 52.204-10, Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020) 52.204-27, Prohibition on a ByteDance Covered Application (JUN 2023) 52.209-6, Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded (JAN 2025) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) 52.219-28, PostAward Small Business Program Rerepresentation (JAN 2025) 52.219-33, Nonmanufacturer Rule (SEP 2021) 52.222-3, Convict Labor (JUN 2003) 52.222-19, Child Labor--Cooperation with Authorities and Remedies (JAN 2025) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) 52.222-50, Combating Trafficking in Persons (NOV 2021) 52.223-23, Sustainable Products and Services (May 2024) [(DEVIATION FEB 2025)] 52.225-1, Buy American--Supplies (OCT 2022) 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) 52.232-33, Payment by Electronic Funds Transfer - System for Award Management (OCT 2018) 52.240-1, Prohibition on Unmanned Aircraft Systems Manufactured or Assembled by American Security Drone Act-Covered Foreign Entities (NOV 2024) All quoters shall submit the following: Please reference RFQ 36C24125Q0506 in the subject line of email response. Failure to include RFQ number could result in response being missed. Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. The following are the decision factors: Price, past performance, speed of delivery and installation The award will be made to the response most advantageous to the Government. Responses should contain your best terms, conditions. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "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:" Quoters shall list exception(s) and rationale for the exception(s), if any. Submission of your response shall be received not later than June 16th, 2025, 5PM EST. All quotes shall be sent via email to Kurt Fritz at kurt.fritz@va.gov Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed above. ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023) Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The version of FAR 52.212-1 in the addendum is tailored for Simplified Acquisition Procedures and supersedes the current version of FAR 52.212-1 contained in the FAR. The following provision is incorporated into 52.212-1 as an addendum to this solicitation: 52.212-1 Instructions to Offerors Commercial Products and Commercial Services (SEP 2023) (a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code(s) and small business size standard(s) for this acquisition appear elsewhere in the Request for Quote (RFQ). However, the small business size standard for a concern that submits an quote, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees, or 150 employees for information technology value-added resellers under NAICS code 541519, if the acquisition (1) Is set aside for small business and has a value above the simplified acquisition threshold; (2) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or (3) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value. (b) Submission of Quotes. Submit signed and dated quotes to the office specified in this Request for Quote (RFQ) at or before the exact time specified in this solicitation. Quotes may be submitted on letterhead stationery, or as otherwise specified in the solicitation. As a minimum, quotes must show (1) The solicitation number. (2) The time specified in the solicitation for receipt of quotations; (3) The name, address, and telephone number of the quoter; (4) A technical description of the items being quoted in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary; (5) Terms of any express warranty; (6) Price and any discount terms; (7) "Remit to" address, if different than mailing address; (8) A completed copy of the representations and certifications at Federal Acquisition Regulation (FAR) 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically); (9) Acknowledgment of Quotation Amendments; (10) Past performance information will not be considered in simplified acquisition procurements. (11) Quotes should include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Quotes 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 Quotes. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of quotes, 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 quotes. 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 Quotes. Quoters are encouraged to submit multiple quotes presenting alternative terms and conditions, including alternative line items (provided that the alternative line items are consistent with FAR subpart 4.10), or alternative commercial products or commercial services for satisfying the requirements of this solicitation. Each quote submitted will be evaluated separately. (f) Late submissions, modifications, revisions, and withdrawals of quotes. (1) Quoters are responsible for submitting quotes, 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 quotes or revisions are due. (2) Any quote received at the Government office designated in the solicitation after the exact time specified for receipt of quotes is "late" and may not be considered unless it is received before purchase order issuance and the Contracting Officer determines that accepting the late quote would not unduly delay the acquisition. (3) If an emergency or unanticipated event interrupts normal Government processes so that quotes cannot be received at the Government office designated for receipt of quotes by the exact time specified in the Request for Quote, 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 quotes 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. (g) Issuance of Purchase Order. The Government may issue a purchase order to one or more quoters as identified in the Request for Quote (RFQ). Therefore, the quoter s initial quote should contain the best terms from a price and technical standpoint. However, the Government may reject any or all quotes if such action is in the public s best interest. In addition, the Contracting Officer (CO) may issue a purchase order to other than the quoter with the lowest quoted price. (h) Multiple awards. The Government may accept issue a purchase order for any item or group of items of a quotation, unless the quoter qualifies the quotation by specific limitations. Unless otherwise provided in the quotation, offers may not be submitted for quantities less than those specified in the RFQ. The Government reserves the right to issue a purchase order for a quantity less than the quantity quoted, at the unit prices quoted, unless the quoter specifies otherwise in the quote. (i) Availability of requirements documents cited in the solicitation. (1) (i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101 29, and copies of Federal specifications, standards, and product descriptions can be downloaded from the ASSIST website at https://assist.dla.mil. (ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained from the address in paragraph (i)(1)(i) of this provision. (2) Most unclassified Defense specifications and standards may be downloaded from the ASSIST website at https://assist.dla.mil. (3) Defense documents not available from the ASSIST website may be requested from the Defense Standardization Program Office by (i) Using the ASSIST feedback module ( https://assist.dla.mil/ feedback); or (ii) Contacting the Defense Standardization Program Office by telephone at 571 767 6688 or email at assisthelp@dla.mil. (4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance. (j) Unique entity identifier.(Applies to all quotes that exceed the micro-purchase threshold, and quotes at or below the micro-purchase threshold if the Request for Quote (RFQ) requires the Contractor to be registered in the System for Award Management (SAM).) The quoter 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 Quoter's name and address. The Quoter 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 Quoter to establish additional SAM records for identifying alternative EFT accounts (see FAR subpart 32.11) for the same entity. If the Quoter 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 Quoter should indicate that it is an planning to submit a quote for a Government Request for Quote (RFQ) when contacting the entity designated at www.sam.gov for establishing the unique entity identifier. (k) [Reserved] (l) Notification. The CO will not notify unsuccessful quoters that responded to this Request for Quotation (RFQ). (End of provision)
