SOLICITATION NOTICE
65 -- Medtronic PTeye Parathyroid Detection System Basic Bundle
- Notice Date
- 3/11/2025 6:32:03 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- 241-NETWORK CONTRACT OFFICE 01 (36C241) TOGUS ME 04330 USA
- ZIP Code
- 04330
- Solicitation Number
- 36C24125Q0296
- Response Due
- 3/11/2025 2:00:00 PM
- Archive Date
- 03/21/2025
- Point of Contact
- Kurt Fritz, Contract Specialist, Phone: 203-932-5711
- E-Mail Address
-
kurt.fritz@va.gov
(kurt.fritz@va.gov)
- Small Business Set-Aside
- SBA Total Small Business Set-Aside (FAR 19.5)
- Awardee
- null
- Description
- Effective Date: 03/15/2023 Revision: 01 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 2024-07. 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. The FSC/PSC is 6515. The Network Contracting Office 1is seeking to purchase Medtronics PTeye Parathyroid Detection System Basic Bundle. All interested companies shall provide quotations for the following: Supplies/Services Line Item Description Quantity Unit of Measure Unit Price Total Price 0001 Medtronics PTeye Parathyroid Detection System Basic Bundle 1 EA White River Junction VA Healthcare System Medtronic PTeye Parathyroid detection system 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 White River Junction VAMC for consideration towards the purchase of imaging table. 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 White River Junction VAMC project management POC, the Vendor will be responsible for coordinating and performing the delivery, implementation, and training for the devices. Background/Justification 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 [If applicable] 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 WRJ VAMC Contractor shall receive and place equipment in the pre-arranged designated areas at the WRJ 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 Biomed 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 WRJ VAMC staff. The WRJ VA will provide a staging area for the equipment to be staged before deployed. Records Management 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. The A&A requirements do not apply, and a Security Accreditation Package is not required. The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. 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 Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal 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. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Products and Commercial Services (November 2023) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products and Commercial Services (January 2025) The following subparagraphs of FAR 52.212-5 are applicable: 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) 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) 52.222-21, Prohibition of Segregated Facilities (APR 2015) 52.222-26, Equal Opportunity (SEP 2016) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) 52.222-50, Combating Trafficking in Persons (NOV 2021) 52.225-1, Buy American--Supplies (OCT 2022) 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 quotes shall be sent to the All quotes shall be sent to the Veterans Health Administration, Regional Procurement Office East, Network Contracting Office 1 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, Delivery Time The award will be made to the response most advantageous to the Government. Responses should contain your best terms, conditions. ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) 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: FAR 52.212-1 Instructions to Offerors Commercial Products and Commercial Services (Nov 2021) (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 a� 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 if the� acquisition Is set aside for small business and has a value above the� simplified acquisition threshold; or Uses the� HUBZone� price evaluation preference regardless of dollar value, unless the� quoter� waives the price evaluation preference; or 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.� Quotes� may� be submitted on letterhead stationery, or as otherwise specified in the� RFQ. 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; 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� quoter� shall� complete electronically); � � � � � � � � � � � (9)� Acknowledgment Request for Quotation amendments; (10)� Past performance� will not be considered in simplified acquisition procurements. (11)� Quote 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 and certifications, information requested in (1) to (9), and accept the terms and conditions of the� solicitation� may� be excluded from consideration. (c)� Period for acceptance of� Quotes. The� quoter� agrees to hold the prices in its� quote� 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 testing. (e)� Multiple� Quotes.� Quoters� are encouraged to submit multiple� quotes� presenting 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, revisions, and withdrawals of� quotes. (1)� Quoters� are responsible for submitting� quotes 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� are due. (2)� Any� quotation 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� (CO) determines that accepting the late� quotation� would not unduly delay the� acquisition. (3)� If an� emergency� or unanticipated event interrupts normal Government processes so that� quotations cannot be received at the Government office designated for receipt of� quotes� by the exact time specified in the� solicitation, and urgent Government requirements preclude a 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. The Contracting Officer (CO) may issue a purchase order to other than the quoter with the lowest priced quotation. (h)� Multiple awards. The Government� may� 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 Schedule,� quotations� may� not be submitted for quantities less than those specified. 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� quotation. � � � � � � (1)� Availability of requirements documents cited in the� solicitation. (i)� The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of specifications, standards, and commercial item descriptions cited in this� solicitation� may� be obtained for a fee by submitting a request to- GSA Federal Supply Service Specifications Section Suite 8100 470 East L Enfant Plaza, SW Washington, DC 20407 Telephone (202) 619-8925, Facsimile (202) 619-8978. (ii)� If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this� solicitation, a single copy of specifications, standards, and commercial item descriptions cited in this� solicitation� may� be obtained free of charge by submitting a request to the addressee in paragraph (i)(1)(i) of this provision. Additional copies will be issued for a fee. (2)� Most unclassified Defense specifications and standards� may� be downloaded from the following ASSIST websites: � � � � � � � � � � � � � � � � (i)� ASSIST (� https://assist.dla.mil/online/start/). � � � � � � � � � � � � � � � � (ii)� Quick Search (� http://quicksearch.dla.mil/).� � � � � � � � � � � (3)� Documents not available from ASSIST� may� be ordered from the Department of Defense Single Stock Point (DoDSSP) by- (i)� Using the ASSIST Shopping Wizard (� https://assist.dla.mil/wizard/index.cfm); (ii)� Phoning the DoDSSP Customer Service Desk (215) 697-2179, Mon-Fri, 0730 to 1600 EST; or (iii)� Ordering from DoDSSP, Building 4, Section D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, Telephone (215) 697-2667/2179, Facsimile (215) 697-1462. (4)� Nongovernment (voluntary) standards� must� be obtained from the organization responsible for their preparation, publication, or maintenance. (j)� Unique entity identifier (UEI). Applies to all quotes� that exceed the� micro-purchase threshold, and� quotes� at or below the� micro-purchase threshold� if the� solicitation� requires the contractor to be� registered in the System for Award Management (SAM).) The� quoter� must� enter, in the block with its name and address on the cover page of its� quote, the annotation ""Unique Entity Identifier"" followed by the� unique entity identifier� that identifies the� quoters name and address. The� quoter� also� must enter its� Electronic Funds Transfer (EFT) indicator, if applicable. The EFT indicator is a four-character suffix to the� UEI. 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 UEI, it� should� contact the entity designated at� www.sam.gov� for� UEI� establishment directly to obtain one. The� quoter� should� indicate that it is a� quoter� for a Government contract when contacting the entity designated at� www.sam.gov� for establishing the� UEI. (k)� [Reserved] (l)� Requests for information. The CO will not notify unsuccessful quoters that responded to this Request for Quotation (RFQ). However, quoters may request information on purchase order(s) resulting from this solicitation with the CO. (End of Provision) 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.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/4c9b2c26c0b44967b7ced8c910c2caf2/view)
- Place of Performance
- Address: White River Junction VA Medical Center 163 Veterans Drive, White River Junction, VT 05009, USA
- Zip Code: 05009
- Country: USA
- Zip Code: 05009
- Record
- SN07368389-F 20250313/250311230044 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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