Inactive

Attachment 1: Combined Synopsis-Solicitation for Commercial Items VHAPM Part 813.106 SAP: Soliciting Competition & Evaluation of Quotations SOP Page 3 of 5 Original Date: 10/12/17 Revision 04 Date: 06... Attachment 1: Combined Synopsis-Solicitation for Commercial Items VHAPM Part 813.106 SAP: Soliciting Competition & Evaluation of Quotations SOP Page 3 of 5 Original Date: 10/12/17 Revision 04 Date: 06/10/20 Description 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; 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 2022-04 dated January 31, 2022 This solicitation is a sole source to Data Sciences International, INC The associated North American Industrial Classification System (NAICS) code for this procurement is 334516, with a small business size standard of 1,000 Employees. The FSC/PSC is 6640. The Network Contracting Office (NCO) 6 Regional Procurement Office (RPO) East is seeking to obtain PhysioTel Digital Telemetry Devices: CLC, TRX-1, APR-2, and DSI Implants. These devices will be used to approved translational research protocols to record of cardiac rhythm and autonomic neural signals in experimental models of cardiomyopathy. All interested companies shall provide quotations for the following: Supplies ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES QUANTITY UNIT UNIT PRICE AMOUNT 0001 1.00 EA __________________ __________________ Communication Link Controller for use with PhysioTel Digital Telemetry LOCAL STOCK NUMBER: 272-8000-001 0002 7.00 EA __________________ __________________ L03 Implant Exchange-Standard Tip 60cm; 60cm Leads 3 Biopotential CH, Temp, Act, Exchange LOCAL STOCK NUMBER: 270-0303-04-04-F1X 0003 12.00 EA __________________ __________________ L11 IMPLANT EXCHANGE- Pressure: 35cm with 12mm tip, Negative Biopotential Solid Tip Lead: 60cm, Positive Biopotential Lead Length: 60cm, Exchange LOCAL STOCK NUMBER: 270-0311-05-00-02-F1X 0004 5.00 EA __________________ __________________ M01 IMPLANT- Negative Biopotential Lead Length: 45cm solid tip, Positive Biopotential Lead Length: 60cm LOCAL STOCK NUMBER: 270-0401-00-03-F1 0005 2.00 EA __________________ __________________ TRX-1, NortH America-Telemetry Transceiver for use with PhysioTel Digital Implants Includes 15 m cable North America Use Only LOCAL STOCK NUMBER: 272-9000-001 0006 1.00 EA __________________ __________________ APR-2-Ambient Pressure Reference Provides an independent measurement of ambient pressure. LOCAL STOCK NUMBER: 275-0025-001 0007 1.00 EA __________________ __________________ Power Supply for CLC / MX2 Required if PoE is not available to power the CLC LOCAL STOCK NUMBER: 370-8000-001 0008 1.00 EA __________________ __________________ Power Cord for 110V Power Supply LOCAL STOCK NUMBER: 274-0009-001 GRAND TOTAL __________________ Statement of Work PhysioTel Digital Telemetry Devices Funded through VA Research 1.1 Purpose The purpose of this Statement of Work (SOW) is to obtain PhysioTel Digital Telemetry Devices: CLC, TRX-1, APR-2, and DSI Implants. These devices will be used to approved translational research protocols to record of cardiac rhythm and autonomic neural signals in experimental models of cardiomyopathy. A total of 5 devices will be purchased to satisfy the experimental needs of the VA Merit-funded research. The objectives of the experiments are to test the swine model to understand the mechanism of this reversible cardiomyopathy (CM). The main purpose of this study is to hopefully validate a similar PVC-Cardiomyopathy model in the swine species. The PhysioTel Digital Telemetry devices will be used with the DSI Ponemah System. 1.2 Scope of Work requires the DSI telemetry devices to perform some of the continuous heart rhythm and nerve activity recordings in ambulatory fashion in animal subjects with cardiomyopathy. The experimentation has IACUC approval. The TRX-1 receives and transmits Radiofrequency (RF) signals from the implants and sends them to the Communication Link Controller (CLC). The Communication Link Controller (CLC) manages communication between the PhysioTel Digital implants and the acquisition computer. The Ambient Pressure Reference Monitor (APR-2) is a special type of barometer that measures atmospheric pressure providing dynamic corrections via a digital signal to the computer. The DSI L03, M01, and L11 devices are pacemaker-sized devices that are implanted into the subcutaneous pocket of the animal, with wires that extend into thoracic cavity and implanted into the heart and cardiac autonomic nerves All together these devices will be used with the DSI Ponemah system which is the hardware recording system that wirelessly captures signals from the implanted devices. Which record heart rhythm and nerve activity continuously from ambulatory subjects. The stored data can be used for analysis. The data is stored offline. 1.5 Risk to the Government There is no risk to the government. The devices will be used for research use to communicate with the devices in the animals. Animals are housed within the animal research facility BC-100 (basement) in Research Service. All personnel are trained through the Safety Office and will wear appropriate personal protective equipment. After extensive research with different companies, the device meets the needs and is reliable. The devices are only compatible with the Ponemah system hardware. Together these devices and Ponemah recording system offer the best performance in nearly every category (digitized signals that does not constrain animal housing and no cross contamination between animal subjects, minimal signal to noise ratio, ease of use, reproducibility) for better experimental yield. 1.6 Contract Security Equipment will NOT be part of an outside network. This device does NOT capture, store, or disseminate patient information (i.e. name, SSN, etc.). It is considered scientific computing instrumentation and will be isolated from the VA network by network isolation (VLAN with ACL). Place of Performance/Place of Delivery Delivery address: Richmond VA Medical Center 1201 Broad Rock Blvd., Richmond, VA 23249 USA FOB Point: Destination Estimated Delivery Date: Within 30 days ARO The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. FAR 52.212-1, Instructions to Offerors Commercial Items 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 provisions are incorporated into 52.212-1 as an addendum to this solicitation FAR 52.212-3, Offerors Representations and Certifications Commercial Items All offerors must be registered in System for Award Management (SAM) at http://www.sam.gov to be considered for an award of a federal contract. The record must be complete and not missing elements such as representations and certifications. 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 Items. If paragraph (j) of the provision is applicable, a written submission is required. The following solicitation provisions apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Items (NOV 2021) Addendum to Far 52.212-4 Show FAR clauses followed by VAAR clauses in numeric order. List all clauses incorporated by reference in numeric order under 52.252-2, starting first with FAR and followed by VAAR. 52.252-2 Clauses Incorporated by Reference (FEB 1998) http://acquisition.gov/comp/far/index.html. FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders (JAN 2021) The following subparagraphs of FAR 52.212-5 are applicable: 52.219-33, Nonmanufacturer Rule (SEP 2021) 52.222-19 Child Labor Cooperation with Authorities and Remedies (JAN 2020) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) 52.225-1 Buy American-Supplies (JAN 2020) 52.232-33, Payment by Electronic Funds Transfer - System for Award Management (OCT 2018) 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998) 52.204-13 System for Award Management (OCT 2018) 52.204-18 Commercial and Government Entity Code Maintenance (AUG 2020) 52.222-50 Combatting Trafficking of Persons (OCT 2020) 52.232-33 Payment by Electronic Funds Transfer-System for Award Management (OCT 2018) 852.212-70 Provisions and Clauses Applicable to VA Acquisition Items (APR 2020) 852.203-70 Commercial Advertising (MAY 2018) 852.212-71 Gray Market Items. (APR 2020) 852.215-71 Evaluation Factors (OCT 2019) 852.232-72 Electronic Submission of Payment Requests (NOV 2018) 852.246-71 Rejected Goods (JAN 2008) 852.273-70 Late Offers GRAY MARKET AND COUNTERFEIT ITEMS INFORMATION TECHNOLOGY MAINTENANCE ALLOWING OTHER-THAN-NEW PARTS (MAR 2020) (DEVIATION) (a) Used, refurbished, or remanufactured parts may be provided. No gray market supplies or equipment shall be provided. Gray market items are OEM goods intentionally or unintentionally sold outside an authorized sales territory or sold by non-authorized dealers in an authorized sales territory. (b) No counterfeit supplies or equipment shall be provided. Counterfeit items include unlawful or unauthorized reproductions, substitutions, or alterations that have been mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified item from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitutions include used items represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics. (c) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors Contractor employees who work in or travel to VHA locations must comply with the following: Documentation requirements: If fully vaccinated, shall show proof of vaccination i.NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination If unvaccinated and granted a medical or religious exception, shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor s order or an FDA approved over-the-counter test. Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel. Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the following website: COVID-19 Screening Tool. Regularly check the website for updates. Contractor employees who work away from VA locations, but who will have direct patient contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities. 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 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 12:00 on March 14, 2022, at Ronnie.Gregory@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 below. Point of Contact Ronnie Gregory, Ronnie.Gregory@va.gov See attached document: PO3 -JNA - redacted.