36C24820Q1563.docx

Contract Opportunity Presolicitation Notice

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* = Required Field Contract Opportunity Presolicitation Notice Supply: SARS-CoV-2 molecular testing modules Emergency 33637 36C24820Q1563 09-18-2020 11:00

EASTERN TIME, NEW YORK, USA

N 325413 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Suite 525 Tampa FL 33637 Michael A Shook Contract Specialist Michael.Shook@va.gov 813-972-2000 Ext 3635 James A Haley Veterans Hospital 13000 Bruce B. Downs BLVD.

Tampa

Florida 33612 United States https://www.va.gov Department Of Veterans Affairs micahel.shook@va.gov Contract Specialist This is a PRE-SOLICITATION ANNOUNCEMENT to announce that the Department of Veterans Affairs (VA), Regional Procurement Office (RPO) 8, James A Haley Veterans Hospital Tampa FL, intends to issue a Request for Quote (RFQ) for Molecular Analyzers. North American Industry Classification System code applicable for this procurement is 325413 Surgical and Medical Manufacturing (standard size 1000 Employees).

The RFQ solicitation 36C24820Q1563 will be posted to the Contract Opportunities website on or before 18th September 2020. All solicitation packages and amendments must be accessed at this website. All amendments issued to this solicitation will also be available at this website and will not be mailed. Offerors are advised that they are responsible for obtaining amendments. Point of contact: Michael Shook, Contract Specialist email: micahel.shook@va.gov and Leslie Hawkins,l Contracting Officer email: leslie.hawkins@va.gov.

STATEMENT OF NEED

GENERAL: James A. Haley Veterans’ Hospital (JAHVH), Pathology & Laboratory Medicine Service (P&LMS), 13000 Bruce B. Downs Blvd, Tampa, Florida 33612, has an emergency requirement for four (4) testing modules capable of running SARS-CoV-2 molecular testing to meet the increased testing demand.

BACKGROUND: JAHVH, P&LMS is currently unable to keep up with the increasing demands of SARS-CoV-2 patient testing with the current molecular systems. This is causing hours of unnecessary delays for our veterans who are kept in the emergency department waiting for their SARS-CoV-2 test results before being admitted to the hospital. Other veterans with routine procedures are being delayed due to the backlog of SARS-CoV-2 samples awaiting testing due to high volume workload we are currently experiencing.

PURPOSE: The addition of these four (4) molecular testing modules with 45-minute SARS-CoV-2 turn-around-time will be a vital component in minimizing SARS-CoV-2 testing delays and providing a higher level of service to our veteran population. These molecular diagnostics modules must be capable of performing SARS-CoV-2 testing.

PHYSICAL CHARACTERISTICS: Equipment must have the physical characteristics to enable the government to perform SARS-CoV-2 molecular testing:

· Can perform Deoxyribonucleic Acid/Ribonucleic Acid (DNA/RNA) extraction, purification and highly multiplexed polymerase chain reaction (PCR).

· Can generate, detect and analyze PCR melting curves. The analysis includes a meta-analysis of all applicable controls and gene targets required for determination of a single result for each organism included in the multiplex reaction.

· Can support fluorescence acquisition Light Emitting Diode (LED) excitation.

· Processes reagent pouches to detect multiple nucleic acid targets contained in clinical specimens.

· Sensitivity and specificity of the System is comparable to that of common commercially available real-time PCR instruments.

· Requires approximately two minutes for set up and completes a run in about one hour.

· Is capable of simultaneous analysis of up to 22 respiratory targets.

· Is fully automated following initial run set-up.

· The systems must improve overall productivity in the Molecular Diagnostics Lab, reducing the need for repeat testing thus reducing reagent waste. The system should not require monitoring during run and should be 100% “walk-away” system.

· Random access operation.

· All in one compact, benchtop modules.

· System must fit within space dimensions (Length, width) Countertop: 48” H x 20” W x 30” D

FUNCTIONAL AND PERFORMANCE CHARACTERISTICS: Equipment must provide the following functional and performance capabilities to ensure equipment is utilized and maintained according to requirements of the system:

· Simultaneously tests for 22 respiratory pathogens and designed to run on a single computer/instrument configuration.

· Automated multiplex PCR testing capability that integrates sample preparation, amplification, detection, and analysis into one easy-to-use system with a test turn-around time of about 45 minutes.

SOFTWARE: Contractor will be responsible for the software system integration and installation to the current VA system to include all fees, parts and work required to accomplish the installation

TRAINING: Contractor is to provide a one-time training at installation of equipment (if applicable). Government will not require additional training.

INSTALLATION: The contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable. Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the customer point of contact, of any issues which may be anticipated in connection with installation or which will affect optimum performance once installation is completed. In the event progress of the installation is interrupted through no fault of the contractor, the installation may be suspended until such time as the cause of delay has been eliminated. The Contractor shall resume the subject installation within 24 hours after the contractor has been notified.

WARRANTY OF EQUIPMENT: Government requirement for standard manufacturer industry warranty term. Government does not accept extended warranty, which requires advance payment.

DELIVERY SCHEDULE: All items to be delivered and or installed within 30 days of purchase order processing and order placement.

PLACE OF DELIVERY: Warehousing Department, James A. Haley Veterans Hospital, 13000 Bruce B. Downs Blvd, Tampa, FL 33612.