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6640--This is Not a Request for Quote Brand Name or Equal Sources Sought Luminex Verigene PCR

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36C24420Q0530Federal

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The Pittsburgh VA Healthcare System is seeking a vendor to supply the Luminex Verigene PCR system or an equivalent product for use in its Microbiology section. The contract requires delivery of the system and related consumables, including at least four processors, a reader system, reagents, and amplification trays under a reagent rental agreement with no minimum kit ordering requirements. The system must provide multiplex testing capabilities for both Gram Negative and Gram Positive organisms, including identification of multiple species and resistance markers, as well as optional respiratory virology and enteric panel testing with flexible pricing and sample options. The methodology should be highly automated with minimal hands-on time and supported by prompt customer service providing same-day ordering, tracking, and status updates. Additional contract requirements include technical support with troubleshooting guidance, onsite preventive maintenance, and repair services during business hours. Kit configurations must allow for efficient sample processing with a minimum of 20 tests per kit. The vendor is responsible for timely delivery of routine consumables and ensuring that all supplies meet quality standards. Vendor performance will be monitored by the VA’s Immunology/Microbiology supervisor, with quality oversight by third-party inspections. The contract encompasses all costs related to instrumentation, reagents, and services needed for molecular multiplex testing and is valid for an initial year with four option years for renewal. Security provisions ensure that VA sensitive information is not involved, while competitive bidding is encouraged in accordance with VA policy. No contractor travel expenses or special packaging requirements are included.

General Info

Supply and maintenance of Luminex Verigene PCR system with multiplex testing and reagent rental.

NAICS

339113 - Surgical Appliance and Supplies Manufacturing

Place of Performance

VA Pittsburgh Healthcare System;Biomed;University Drive C;Pittsburgh PA, PA, 15240, USA

Set-Aside

NONE

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Timeline

PhaseSources Sought
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Sources Sought

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → 244-NETWORK Contract Office 4 (36C244)
Contacts1 person available
OfficePITTSBURGH, PA, 15215, USA
Office AddressPITTSBURGH, PA, 15215, USA
Contacts

Full Description

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The Pittsburgh VA Healthcare System requires a Luminex Verigene PCR to be delivered to the Pittsburgh VA Medical Center Microbiology section, University Drive C, Pittsburgh PA 15240. Please provide your entities information for providing the Luminex Verigene PCR or equal product and/or an authorized distribution letter to Jason May, Contract Specialist by email contact@example.gov by 05-01-2020 at 4:00 PM EST; reference Source Sought Notice 36C24420Q0530 in the subject line of the email. This contract is required as it is driven by policy to offer the best methodologies available. Current available PCR methods offer automated, cost-effective multiplex capabilities that rapidly and accurately detect infectious pathogens and drug resistance markers without relying on time-consuming culture methods. Delivery of this time-critical information enables clinicians to provide targeted patient care more quickly, potentially leading to improved patient outcomes, lower costs, optimized antibiotic therapy, reduced spread of antibiotic resistance and importantly, saved lives. Rapid molecular testing is powering faster treatment decisions in more than half of the top US hospitals. The ease of use makes it a valuable system for use in both hospital-based and reference laboratories, regardless of size, and features: The Pittsburgh VA Medical Center has been employing this type of molecular testing for several years. Continued financial support is essential in order to maintain current diagnostic capabilities. In addition, several supplies are required by the Microbiology lab. These include processing equipment, reagents, amplification trays, and a reader system. All these items should be ordered from commercial distributors. Salient Characteristics: The selected vendor will provide the best patient care clearly demonstrating the ability to directly provide at least 4 processors, a reader system, reagents, and amplification trays included in a reagent rental agreement with no minimal kit ordering requirements. The selected vendor will offer multi-plex testing separately for both Gram Negative (GN) and Gram Positive (GP) organisms. This is to include resistance marker identification concurrently with organism identification. The selected vendor will offer at least 9 distinct GP species identification, 4 genus GP identifications, and mecA, vanA, and vanB resistant markers. The selected vendor will offer at least 5 distinct GN species identification, 4 genus GN identifications, and CTX-M (ESBL), IMP (carbapenemase), KPC (carbapenemase), NDM (carbapenemase), OXA (carbapenemase), and VIM (carbapenemase) resistant markers. The selected vendor will provide a flex option for Respiratory Virology testing in order to minimize panel costs. The selected vendor will offer user a broad panel of 16 viral and bacterial targets. Any combination of targets can be selected for an individual sample at the time of test ordering. Additional results not initially reported after test completion can be reflexed instantly at an extra cost without running an additional test. The selected vendor will provide Enteric Panel testing that would include both Norovirus and Rotavirus testing on stool samples. The selected vendor will pursue a Flex option for enteric testing. The selected vendor will work to amend the current contract to include Enteric flex pricing upon FDA approval. The selected vendor will utilize a methodology that requires minimal hands on time. This requirement should not exceed 5 minutes. The selected vendor will utilize a customer service center to provide same day ordering/tracking/status services. It is incumbent upon the vendor to provide same day service. Vendors that utilize answering machines are not acceptable. The selected vendor will provide confirmation numbers and arrival dates for all items ordered. This expectation is mandatory in order to obtain proof for invoicing. This contract includes all the costs, instrumentation, and reagents associated with performing multiplex molecular testing for GP, GN, Respiratory Virology, and Enteric bacteria and viruses. This contract is specifically for the use of the Pittsburgh VA Medical Center Microbiology section. This contract is required to provide pricing for all necessary consumables required to perform multiplex molecular testing for GP, GN, Respiratory Virology, and Enteric bacteria and viruses. The contract will provide the selected vendor to bill, monthly, for additional Respiratory pathogen target groups that are accessed for results beyond the initial kit cost. Technical Service. Provide technical and functional courses of action to remedy minor trouble shooting that can be accomplished by the technologist within 30 minutes. Provide onsite preventative maintenance and repair of analyzers Mon-Fri from 0600 until 1700. Kit Configurations To maximize sample processing efficiency, it is required that the vendor provide the ability for the ordering institution to obtain kit configurations that provide at least 20 tests/kit. Deliverables: The following routine consumables needed: Item # Description/Part Number* Verigene BC-GP Kit and extraction tray 20-005-018 Verigene BC-GP Utility Tray 20-012-018 Verigene BC-GN Kit and extraction tray 20-005-021 Verigene BC-GN Utility Tray 20-012-021 Verigene Enteric Kit and extraction tray 20-005-023 Verigene Enteric Amplification Tray 20-012-023 Verigene RP Flex kit and extraction tray 20-005-024 Verigene RP Utility Tray 20-012-024 Flex Reveal Additional Testing It will be the responsibility of the Pittsburgh VA Medical center Immunology/Microbiology Supervisor/designee to monitor all performance issues with the vendor. Timely delivery of supplies, prompt and professional technical service, Mon-Fri, will be evaluated and compared to the terms of the contract. Compliance and quality management performance of the method will be maintained by third party inspections and routine quality testing/review by the College of American Pathologists. In accordance with VA policy, contractors storage, generation, transmission or exchanging of VA sensitive information requires appropriate security controls to be in place. This is an acquisition or purchase of commodities, goods (e.g. equipment or software), and technical/field service support to maintain the analyzers. VA sensitive information is not involved in the course of these procedures (see Appendix A). No GFE or GFI will be needed in any capacity. It is the policy of the Pittsburgh VA Medical Center Immunology/Microbiology laboratory to encourage and actively solicit competitive bids from all vendors competing for similar business. a. Identification of Possible Follow-on Work. Not Applicable b. Identification of Potential Conflicts of Interest (COI). Not applicable. c. Identification of Non-Disclosure Requirements. This is an acquisition or purchase of commodities, goods (e.g. equipment or software), and technical/field service support to maintain the analyzers. VA sensitive information is not involved in the course of these procedures. d. Packaging, Packing and Shipping Instructions. There is no special packaging and shipping instructions required. All items are shipped as per the vendor s specifications to ensure quality of products and goods. e. Inspection and Acceptance Criteria. All received products and goods are examined for quality and acceptability without exception. Acceptable products are signed for by the laboratory. No additional risk will be undertaken by the laboratory as compared to any other vendor or method. The equipment and supplies will be located in room 2NW110 and 2NW111. No contractor travel expenses are included in this contract. This contract will be valid for a 1-year time period. In addition, the contract should contain 4 additional option years.

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