SPECIAL NOTICE
65 -- NOTICE OF INTENT TO SOLE SOURCE MEDISTIM FLOWMETERS AND EPICARDIAC PROBES
- Notice Date
- 1/31/2022 10:10:50 AM
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- 244-NETWORK CONTRACT OFFICE 4 (36C244) PITTSBURGH PA 15215 USA
- ZIP Code
- 15215
- Solicitation Number
- 36C24422Q0207
- Archive Date
- 02/03/2022
- Point of Contact
- Mr. LaShawn Knight, Contract Specialist, Phone: 302-287-6554
- E-Mail Address
-
lashawn.knight@va.gov
(lashawn.knight@va.gov)
- Awardee
- null
- Description
- Notice of Intent to Award a Sole Source Procurement Subject: Medistim USA, Inc Posting Date: January 31, 2022 Due Date: February 4, 2021 15:00 PM EST Solicitation No.: 36C24822Q0207 This is a Notice of Intent published in accordance with Federal Acquisition Regulation (FAR) 5.101(a)(1) requiring the dissemination of information regarding proposed contract actions. This Notice of Intent is for a proposed award of a sole source, firm-fixed price contract under the authority of 41 U.S.C. 3304(a)(1), as implemented by FAR 13.106-1(b) - Only One Responsible Source and No Other Supplies or Service Will Satisfy Agency Requirements. The primary North American Classification System Code (NAICS) is 339112 Surgical and Medical Instrument Manufacturing. The Product Service Code (PSC) is 6515 - Medical Equipment and Accessories and Supplies. The most current Business Size Rating for this NAICS is 1,000. This is not a request for competitive proposals or a request for offers. The Department of Veterans Affairs, VA Pittsburgh Healthcare System intends to award a sole source, firm-fixed price contract Medistim USA, Inc of Plymouth, MN under the authority FAR 6.302-1. Medistim USA, Inc is the Original Equipment Manufacturer (OEM) for the MEDISTIM MIRAQ FLOWMETER AND PROBES. The proposed sole source action is to establish source(s) of supply that will allow familiarity of the Medistim that the facility are attempting to replace and an addition for their Transcatheter Aortic Valve Replacement TAVR activation, this is the only device that will meet all of the Cardiac Surgery requirements. All responses received within six (5) business days after the date of publication of this notice will be reviewed by the Contracting Officer. A determination by the Contracting Officer not to compete this proposed action will be based on the responses to this notice and solely to the discretion of the Contracting Officer. All responses must be e-mailed to lashawn.knight@va.gov by 15:00 PM EST on Friday, February 4, 2022. VA Pittsburgh Healthcare System (VAPHS) SCOPE OF WORK AND GENERAL SPECIFICATIONS FOR MEDISTIM MIRAQ FLOWMETER AND PROBES Background VA Pittsburgh Cardiac Surgery program and the forthcoming activation of the Transcatheter Aortic Valve Replacement (TAVR) suite require the need to check the patency of cardiac surgery bypass grafts, intraoperatively. The Medistim flow meter/probes is the standard of care for patients who are undergoing Coronary artery bypass graft (CABG) surgery. This technology allows surgeons to check the patency of the bypass grafts in real-time and make an informed assessment of the quality of the bypass graft, to treat accordingly. There are no other alternative equipment options to meet this level of standard of care in the industry. The use of these flowmeters and probes would ultimately serve to improve the quality of care for Veterans having to undergo a CABG procedure. Specifications of Equipment/Quantity Needed The system warranty must be against, at a minimum, defective material or poor workmanship for 2 years The probe warranty must be against defective material or poor workmanship for 1 year Must include a quantity of 2 of ultimate flowmeters w/imaging Must include a quantity of 4, 15MHz epicardiac probes Probe technology that pairs with this system must utilize reliable transit time flow measurement (TTFM) technology so that accurate measurement of volumetric blood flow intraoperatively may occur Delivery Location Attn: Joshua Olexa 2A118 VA Pittsburgh Healthcare System University Drive C Building 1 Pittsburgh, PA 15240-1001 Delivery should be coordinated with the COR of the contract prior to shipping of any equipment The Contractor must comply and provide all necessary information to VAPHS. Otherwise, the delivery may be refused and require redelivery at no additional cost to the government. Normal business hours for acceptance of deliveries are 8:00am-3:30pm, Monday thru Friday excluding Federal Holidays. Deliveries must be coordinated in advance with COR once a ship date is established. The COR, Biomedical Engineering and/or Logistics Representative shall be the only VA entity signing for freight received on this requirement. The VA-issued purchase order number must be included in the packing slip. All items included in the requirement shall be shipped and delivered to site at same time. If deliveries must be broken into several shipments due to size, this must be coordinated in advance with the COR. Failure the coordinate shipment with COR, may result in failure to deliver on site and cause re-scheduling of delivery/freight at no charge to the government. The packing slip must include the VA-issued purchase order number Training Any training scheduled should be coordinated with the COR and VA staff. Additional Charges There will be no additional charge for time spent at the site during, or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts or installation. There will be no additional charges for time spent assembling the equipment. There will be no additional charges for any time spent on-site provided training to either clinical or technical staff. There will be no additional charges with the waste management protocol listed in section 8. Packaging Waste management Contractor shall remove packaging materials and all shipping debris from site and dispose of at appropriate recycling facilities. Contractor shall collect and separate for disposal all paper, plastic, polystyrene, corrugated cardboard, packaging material in appropriate bins for recycling on site if available. Contract shall fold metal and plastic banding, flatten and place in designated areas for trash. 10. Influenza Vaccination VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Health care personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical, and administrative, paid, and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. This requirement is extended to all Contractor personnel with potential to come into minimal contact (passing in the corridor) with any patients, visitors, or staff members at VAPHS. Those individuals unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center. It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation: - Documentation of vaccination, e.g., signed record of immunization from a health care provider or pharmacy, or a copy of medical records documenting the vaccination. - Completed Health Care Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine. The contractor is required to submit annual certification in the form of a memorandum to the Contracting Officer s Representative (COR) that all contract staff performing services at VA facilities follows VHA Directive 1192. 12. HIPAA Training Certificates If Contractor will be working onsite for installation and activation of equipment, all HIPAA training completion documentation must be provided to the COR listed in the awarded contract. 13. Tobacco All VA Pittsburgh property is tobacco free. Contractor personnel will comply with VA Pittsburgh tobacco and smoking policies. Violations will result in a warning and possible citation. 14. COVID-19 Related Policies Upon entering VAPHS, per CDC and federal regulations, all personnel must wear the required PPE while on-site; at a minimum this includes a cloth mask. PPE will not be provided by VAPHS. All individuals are required to enter through the main entrance for temperature screening. If Contractor s temperature exceeds the designated threshold, they will be asked to leave. In the event of an FSE being forced to vacate the premises, they shall notify the necessary Biomedical Engineering staff and provide a contact for a replacement. 15. Vendor Credentialing Vendor access to the VAPHS is by appointment only and requires credentialing through our vendor credentialing partner, Symplr at https://vcsdatabase.com/login Symplr registration is at cost to the vendor only and VAPHS is not responsible for this. All vendors are required to check-in at the Symplr kiosk using their smart phone (University Drive) or desktop check-in with Symplr login (HJH) and obtain a day badge, which will include date, time, and location of approved appointment. Company badge with photo ID is also required to be worn while onsite at any of the VAPHS sites. Vendors are only permitted to visit the location identified on their Symplr generated badge and must exit the facility promptly, checking out via their smart phone once the scheduled appointment has ended.
- Web Link
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- Record
- SN06228446-F 20220202/220131230106 (samdaily.us)
- Source
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