36C24819Q1535-001.docx

Combined Synopsis/Solicitation Notice This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. Solicitation number 36C24819Q1535 is issued as a Request for Quotation (RFQ). This document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC Number: 2019-06, Effective Date: September 10, 2019. This procurement is set-aside based on an order of priority as established in 38 U.S.C. 8127.

The associated North American Industry Classification System (NAICS) Code for this acquisition is 334516, size standard 1000 Employees.

This solicitation is set aside 100% for Service-Disabled Veteran-Owned Small Business.

Supply : Heart Lung Perfusion System Price COST Schedule

Heart Lung Perfusion System

Electronic Data Management System

DELIVERY SCHEDULE

13000 BRUCE B. DOWNS

TAMPA, FL 33612

FOB: Destination

STATEMENT OF NEED

GENERAL: The Cardio Thoracic Section of Surgical Service at the James A. Haley Veterans’ Hospital, 13000 Bruce B. Downs Blvd, Tampa, Florida 33612, has an immediate requirement for 2 Heart-Lung Machines. Heart-Lung Machines are critical equipment necessary for use during surgeries involving life-saving open-heart procedures including those performed in the Cardio-Thoracic Surgical Suite, Hybrid Operating Room, and or Cardiac Catherization Lab.

BACKGROUND: A cardiopulmonary bypass machine (CBM) is commonly known as a heart-lung bypass machine. It is a device that does the work of providing blood (and oxygen) to the body when the heart is stopped for a surgical procedure. In most cases, the machine is used to perform serious procedures that require the heart to be stopped. Patients are on the pump only if it takes to stop the heart from beating, complete open-heart surgery or a procedure on the lungs, and restart the heart.

SCOPE: The overall system should be delivered complete with drive unit, control panel, connection cable, sensor module for flow measurement, flow sensor and emergency system. The emergency system (ERC) should close the arterial line in a fraction of a second if an alarm is triggered (e.g. retrograde flow, level or bubble alarm), keeping the danger of air delivery to a minimum and thus adding an additional measure of safety to our veteran population.

Specific Need

· Integrated perfusion circuit to interface with anesthesia data management and patient records.

· Safety features including automated Venous Occluder, air-detector, level-alarm sensors, and pressure sensors.

· Heart lung machine module components should be able to run independently.

· Electronic Data-Management System should be able to interface with current data management system (Patient Management Software for Surgical Journey) (PICIS).

SPECIFIC NEED/ SALIENT CHARACTERISTIC’S

· Clear, descriptive menu-system and one-touch accessibility which will make it more convenient for the Perfusionist.

· Should be light weight and maneuverability and High-resolution displays

· Generates and exports electronic medical records and allows full customization

· Recorder to record alarm activity and actions taken

· Collects and visualizes data from HLM and other external devices such as HMS (ACT-ABG); SAT/HCT monitor; Anesthesia Monitors

· Single-touch event entries at any time

Delivery address: James A. Haley Veterans Hospital, 13000 Bruce B. Downs Blvd, Cardio Thoracic Section – Main OR, Bldg. 1, Tampa, FL 33612.

DELIVERY SCHEDULE: All items to be delivered and installed within 60 days of purchase order processing and order placement. FOB destination pricing.

WARRANTY OF EQUIPMENT: Contractor must provide manufacturer(s) warranty on all provided supplies.

The following Clauses applies to this acquisition:

The clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and no additional addenda to the clause included

The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition.

· 52.225-13

The clause at VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESS SET-ASIDE (JUL 2016)(DEVIATION)

The clause at VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

The clause at VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984)

The clause at VAAR 852.246-71 REJECTED GOODS (OCT 2018)

The clause at VAAR 852.273-70 LATE OFFERS (JAN 2003)

The following Provisions applies to this acquisition:

The provision at 52.204-7, System for Award Management (Oct 2016) ADDENDUM to 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 following provisions are incorporated into 52.212-1 as an addendum to this solicitation:

· To be considered for award, quoter is to complete price cost schedule. Quoter shall email this information to the contract specialist Calixte Saintil / Johnny Jones at Calixte.Saintil@va.gov/Johnny.Jones@va.gov on or before the due date and time for quote submission as found in block 8 of the SF1449.

· Questions: All questions must be received by September 20, 2019 at 3:30pm EST. All questions submitted for this solicitation must be electronically sent to the Contract Specialist. Questions received after the stated date and time, may be addressed at the discretion of the Contract Specialist.

· Quote Submission: The contractors shall submit complete emailed electronic copy portable document format (.pdf) or Microsoft Excel (.xls) format of:

· Government evaluation will not be based upon Price alone.

Gray Market Prevention Language

(a) Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable.

(b) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM’s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions.

(c) The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA’s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.

ADDENDUM to The provision at 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014) The Government will award a Firm-Fixed Price contract to the responsible quoter using a comparative evaluation. The comparative evaluation will be performed in accordance with FAR 13.106-2(b)(3). The government reserves the right to select a quotation that provides benefit to the government that exceeds the minimum but is not required to do so. Quoters are advised that quotation may exceed the requirements, but the government is not requesting or accepting alternate quotes; each response must respond to the solicitation requirement, stated in the RFQ.

The government will apply the following comparative evaluation process as the basis for award:

Assess the direct comparison of one quote with another in a uniform and fair manner to determine which quote provides the government what it needs, where and when in accordance with the Statement of Need (SON) and this Request for Quote. It is an assessment of which response is “best” as a whole.

Once one quotation is found acceptable, it is compared side-by-side to the remaining ones, and the “best” one is chosen for the best value to the government.

The following comparative evaluation factors shall be used:

- Technical: Each offeror’s quote shall be evaluated based on equipment specifications, to determine if the offeror provides a sound, compliant approach that meets the requirements of the Statement of Need and demonstrates a thorough knowledge and understanding of those requirements and their associated risk.

- Delivery Date: The purpose of the delivery factor is to assess the offeror’s shipment information and after receipt of order (ARO) delivery days to meet the Government’s delivery timeframe of 60 days ARO.

- Past Performance: The Government may rely on internal documentation including the Contract Performance Assessment Reporting System (CPARS) and contracting officer’s knowledge of and previous experience with supply or service being acquired for determining Past Performance. If no record of past performance is found in CPARS, the contract shall not receive a favorable or unfavorable rating Price shall be submitted using the enclosed Price Schedule or Contractor quote.

Information not contained in a vendor’s quote will not be considered during the evaluation. The Government intends to make award selection without clarification but may determine after evaluating submitted quotes that the elements stated in FAR 13.106-2(b)(3) for evaluation procedures are necessary and conduct them as appropriate. The Government reserves the right to make no award if no quotes meet the requirements of this solicitation.

The provision at 52.212-3 Offeror Representations and Certifications-Commercial Items. The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal

All quoters categorized as Veteran concern must be certified as a Service Disabled Veteran Owned Small Business (SDVOSB) in VetBiz/VIP: https://www.vip.vetbiz.gov/ prior to award. All quoters must have an active and complete registration in SAM: https://www.sam.gov/portal/SAM/ prior to award.

The Defense Priorities and Allocations System (DPAS) and assigned rating is not applicable.

Any questions concerning this solicitation shall be submitted to Calixte Saintil via email: Calixte.Saintil@va.gov, no later than September 20, 2019. All quotes shall be submitted to Calixte Saintil and Frank Lloyd via email: Calixte.Saintil@va.gov and Johnny.Jones@va.gov not later than September 23, 2019, 11:00 AM, EST.