Statement of Work VISN 8 Molecular Pathogen Detection_draft.docx

STATEMENT OF WORK

Project Name & ID: Molecular Pathogen Detection Analyzers and Test Panels

1. Background:

1.1 The Government has a requirement for Molecular Pathogen Detection reagents supply purchase with equipment lease capable of running the following in-vitro diagnostics (IVD) test/panels with accompanying verification kits for all Pathology & Laboratory Medicine Service (P&LMS) locations in VISN 08 to provide the best patient care to our Veteran population.

1.1.1. Gastrointestinal (GI) Panel

1.1.2. Meningitis/Encephalitis (ME) Panel

1.1.3. Joint Infection (JI) Panel

1.1.4. Pneumonia (PN) Panel

1.1.5. Blood Culture Identification (BCID) Panel

1.1.6. Respiratory (RP) Panel

1.2. The requirement is for the below list of participating VISN 08 Sites:

Bay Pines, FL 33744

Gainesville, FL 32608-1197

Miami, FL 33125

Orlando, FL 32827

Tampa, FL 33612

West Palm Beach, FL 33410-6400

San Juan, PR 00921-3201

2. Scope:

2.1 The multiplexed molecular diagnostic testing platforms shall provide molecular pathogen detection as describe above (1.1). Additional testing and testing sites may be added based on Veteran care needs and availability. Equipment should meet or exceed the below specifications for brand name or equivalent Biomerieux Biofire FilmArray (FA) Torch Multiplex PCR system.

3. Requirements:

3.1 Analyzer capabilities and performance:

The multiplexed molecular diagnostic testing platform offered under this contract shall comply with all general requirements stated herein. The contractor shall provide the following systems with all equipment and accessories to all VISN 08 P&LMS sites:

a. FDA-approved automated multiplex PCR testing capability that integrates sample preparation, amplification, detection, and analysis into one easy-to-use single computer/instrument configuration platform with panel test completion in about 1 hour.

b. Performs Deoxyribonucleic Acid/Ribonucleic Acid (DNA/RNA) extraction, purification, and highly multiplexed polymerase chain reaction (PCR) testing.

c. Generates, detects, and analyzes 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.

d. Utilizes fluorescence acquisition Light Emitting Diode (LED) excitation.

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

f. Integrated computer and analysis software with printer provided for each system.

g. Touch screen interface and integrated barcode scanner with each system.

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

i. Fully automated following initial run set-up and start.

j. System does not require monitoring during run.

k. All in one compact benchtop lease unit integrated system including the system base, duplex (module enclosure) and modules (main analyzer).

3.2 Software:

a) The offered clinical system software shall have the immediate capability to interface with Government’s approved middleware system.

b) Contractor must provide all necessary software/hardware (drivers) for bidirectional interface with VISTA.

c) Shall provide the supporting documentation required to maintain or improve the level of data retrieval, which may be used for epidemiology measures.

d) Must be capable of printing/displaying calibration verification and all internal QC.

e) Shall be compatible with all barcode style formats.

f) The contractor must provide all updates/upgrades to the operating system software, without additional cost to the Government.

g) Manufacturer’s system documents/ operator’s manuals shall be furnished with each model supplied. Electronic formats are acceptable. Procedures shall be provided in accordance with the Clinical and Laboratory Standards Institute (CLSI) format.

3.3 Instrument space, electrical and ambient requirements:

a. Each system must fit within general space dimensions of a minimum (Width x Depth x Height) Countertop: 20” W x 30” D x 36” H.

b. Power requirements for each system: 100-240 VAC, 50-60 Hz.

c. Contractor provided Uninterruptible Power Supply (UPS) for each system.

d. All models shall perform satisfactorily at recommended laboratory temperature between 59- to 89-degrees F (15 to 32 degrees Celsius) and recommended laboratory relative humidity of less than 80% without condensation.

e. The contractor must provide all updates/upgrades to the hardware covered under standard warranty, without additional cost to the Government.

3.4 Testing Requirements:

Functionality and performance specifications of FDA-approved sample-to-answer pathogen testing panels using a single patient sample with test results in about one hour as describe below:

a. Gastrointestinal (GI) panel testing capable of simultaneously testing for 22 of the most causes of gastroenteritis infections including bacteria, viruses, and parasites targets.

b. Meningitis/Encephalitis (ME) panel testing capable of simultaneously testing for 14 spinal fluid causing pathogens including bacteria, viruses, and yeast.

c. Joint Infection (JI) panel testing capable of simultaneously testing for 39 bacteria, yeast, and antimicrobial resistance pathogens.

d. Pneumonia (PN) panel testing capable of simultaneously testing for 33 bacterial, viral, and antimicrobial resistance gene targets using lower respiratory samples.

e. Blood culture identification (BCID2) panel testing capable of simultaneously testing for 43 different organism and organism groups that cause bloodstream infections and three genetic markers that are known to confer antimicrobial resistance. Includes rapid, direct identification of bacteria in positive blood cultures.

f. Respiratory 2.1 (RP2.1) panel testing capable of simultaneously testing for 22 respiratory pathogens including COVID-19.

g. Multiplex panel testing turn-around time of about one hour.

h. Reagent panel test kits can be stored at room temperature.

i. Reagent panel test kits contain all necessary reagents for sample prep, PCR, internal controls, and detection.

j. Assay panels requires less than 3 minutes of hands-on time.

k. All assays contain all necessary internal controls.

l. Verification Kits included for all panel assays and applicable test validations.

m. User training for government personnel.

3.5 Annual estimated quantities for each VISN 8 Site:

*All locations, Miami VA, West Palm Beach VA, Gainesville VA, San Juan VA, Bay Pines VA, and Tampa VA, will keep the existing number of analyzers, including base(s) units, duplex unit(s) and modules.

**Orlando VAMC wishes to add to their existing number of analyzers two (2) new Torch duplex units and four (4) new Torch modules.

Quantities are estimates only.

4. Delivery:

4.1 Delivery location/time lease instruments: Delivery of new analyzers, including base systems, duplex housing, modules, and hardware accessories (printers/UPS) will be delivered to each VISN 08 location (see section 1.2), Monday-Friday (M-F), excluding Weekends and Holidays during regular business hours from 0730-1600 (ET) within ten (10) business days after receipt of the award.

4.2 Delivery location/time supplies: Delivery of verification kits, reagents, and consumables will be delivered to each VISN 08 location (see section 1.2), Monday-Friday, excluding Weekends and Holidays during regular business hours from 0730-1600 (ET) within two (2) business days after receipt of order (ARO).

4.3 Delays of shipments must be communicated to COR and arrangements made for earliest shipment. Allocation schedule subject to change due to allocation procedures, if any.

4.4 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 when applicable. Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the COR 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. All work is to be performed in accordance with the guidelines established by Federal, State, and Local ordinances, with the FDA and manufacturer’s guidelines, and with all terms, conditions, provisions, schedules, and specifications provided herein.

4.4 The contractor must provide all operational updates/upgrades to the equipment hardware and operating system software that materially affects the performance of the equipment covered under the standard warranty, without additional charge to the government. These enhancements to the contractor’s equipment shall be delivered to the government site and installed by the contractor within ten (10) working days of their issuance or date of first commercial availability.

4.5 Ownership of the instrument shall remain with the contractor for the life of the lease agreement. All equipment accessories (hardware and software) furnished by the contractor shall accompany the equipment when returned to the contractor. The contractor, upon expiration of order(s) at termination and/or replacement of equipment, will remove the equipment and turn in any hard drives containing VA sensitive information to VA IT. The contractor will disconnect the equipment and will be responsible for all decontaminating, packing, and shipping required to remove the equipment within ten (10) business days.

4.6 Operational use time for performance testing for a system is defined as the accumulated time during which the equipment is in actual use. System failure downtime is that period when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the government makes a bona fide attempt to contact the contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the government in proper operating condition.

4.7 During the contract period, should the repair record of any laboratory equipment reflect a downtime of 10% or more: of the normal working days in one (1) calendar month, a determination may be made by the designated representative of the Government (COR) at the using facility to replace the initial laboratory equipment with new equipment covered under the standard warranty.

5. Training of Operating Personnel:

7. Delivery Locations/Payments/Period of performance:

7.1 Deliverables: Analyzers (including base unit, duplex, modules), reagents, verification kits and any other supply or items ordered to ship FOB destination. Each order placed by each site/medical center will specify person of contact, section, service, delivery address, items, and quantities needed.